Total hip arthroplasty (THA) is a highly effective procedure for improving pain and function in patients with advanced joint degeneration; however, revision surgery may be required because of complications or implant wear. Revision THA (rTHA) has a higher in-hospital mortality rate, longer hospital length of stay, are at higher risk of re-revision surgery and have worse physical and mental health outcome measures compared with primary THAs. The introduction of specialist revision hubs also means that patients frequently travel further for surgery. No specific guidelines have been established for rehabilitation after rTHA, leading to large variations in practice and potentially inadequate provision. We hypothesise that delivering a tailored physiotherapy intervention will improve and sustain greater functional outcomes and health-related quality of life compared with standard protocols currently in place. The aim of this study is to determine the feasibility and explore the acceptability of a trial investigating the effectiveness of a tailored physiotherapy intervention after rTHA.
Multicentre, parallel two-arm feasibility randomised controlled trial with an embedded qualitative study. A total of 60 participants will be recruited from at least four UK NHS secondary care hospitals and randomly allocated (1:1 ratio) to either the tailored physiotherapy rehabilitation (THRIVE) programme or a standardised usual care arm. Eligible adults will be undergoing a single or final stage rTHA and participating in outpatient physiotherapy. Feasibility outcomes include recruitment rate, retention rate, adherence rate, intervention fidelity, outcome measure completion and acceptability of the intervention. Research assessments consisting of patient-reported and performance-based measures will occur preoperatively (baseline), with follow-ups at 4 and 8 months postoperatively. Feasibility data will be analysed using descriptive statistics. The embedded qualitative study will include trial participants and physiotherapists from the THRIVE arm to explore their experience of the trial and understand measures to improve the delivery of a future trial.
The study has received ethical approval (West of Scotland REC 25/WS/0080), and all participants will provide informed consent. It will assess trial feasibility while exploring operational and safety challenges, including recruitment barriers and the potential value of a hub-and-spoke model for delivering physiotherapy. Findings will be disseminated through trial registry reporting, peer-reviewed open-access publication, conference presentations and participant summaries, with reporting aligned to CONSORT guidelines for pilot and feasibility trials.
Multiple sclerosis (MS) frequently leads to mobility impairment, fatigue and a significant decline in health-related quality of life (QoL). Home-based assistive technology, such as robotic exoskeletons, offers a promising solution to enhance independent mobility and increase the intensity of motor training. Long-term functional and quality of life benefits of light lower-limb exoskeleton home use have yet to be determined.
The primary objective of this study is to determine the efficacy of an 8-week period, home-based use of a robotic exoskeleton in improving QoL in individuals with MS, compared with a no-device control period.
This is a multicentre, randomised, controlled and single-blinded cross-over trial. A total of 28 patients with confirmed MS (Expanded Disability Status Scale (EDSS) score 5.0–7.0) will be recruited across three rehabilitation centres. Participants will be randomly assigned to two 8-week phases: intervention (daily home-based exoskeleton use) or control (physical activity advice), separated by an 8-week wash-out period. The primary outcome is the change in the MS Quality of Life assessed by the Functional Assessment of Multiple Sclerosis (FAMS) physical composite score from baseline to the end of each phase. Secondary outcomes include changes in walking performance (2-minute Walk, 10 M Walk, Timed Up-and-Go, Four Square Step Test and Sit-to-Stand Test), fatigue severity (Fatigue Severity Scale and Fatigue Impact Measurement Scale (EMIF)-MS), and strength capacity (Manual Muscle Testing, Tardieu scale), self-confidence (Rosenberg), anxiety and depression (Hospital Anxiety and Depression Scale), satisfaction to use (Technical Aid Satisfaction Scale) and intention to use (Unified Theory of Acceptance and Use of Technology).
This study was registered on ClinicalTrials.gov on 1 February 2024 (Trial registration number: NCT05835622 https://clinicaltrials.gov/ct2/show/NCT05835622). Patient recruitment is currently underway and is anticipated to be completed by January 2026. Primary endpoint data collection is expected to be completed in June 2026.
This study protocol describes a rigorous trial designed to provide high-level evidence on the impact of a home-based robotic exoskeleton on QoL in individuals with MS. By determining intervention effectiveness, the results will provide clinical guidelines, potentially facilitating the widespread adoption of home-based assistive robotics to substantially improve the independence and overall QoL for patients with MS.
This study explored the lived experiences, challenges and coping strategies of Arab male patients with spinal cord injury (SCI) who rely on intermittent catheterisation (IC) to manage neurogenic bladder.
A descriptive qualitative approach was employed, with data analysed using a phenomenological framework.
Rehabilitation Hospital, King Fahad Medical City, Riyadh, Saudi Arabia.
Male patients with SCI undergoing rehabilitation and performing IC were included in the study. Although both male and female patients were approached to participate, all eligible female patients declined participation. During the recruitment process, some female patients informally expressed privacy concerns and discomfort related to discussing bladder management issues and genital care, which may have contributed to their decision to decline participation.
10 male participants with SCI were recruited after eligible female patients declined participation. Three main themes, each with associated subthemes, emerged to reflect the participants’ experiences. Theme 1: Frequent use of IC in daily life, comprised four subthemes: (1) frequency of practice, (2) environmental and health-related challenges, (3) privacy during IC and (4) fluid intake and output. Theme 2: Cleanliness and general care included two subthemes: (1) catheter cleaning and (2) incontinence. Theme 3 focused on body image and sexuality. Cultural and social norms, including privacy concerns and sensitivities surrounding intimate care in the local context, played a significant role in shaping participants’ experiences and coping strategies.
IC was associated with challenges affecting multiple aspects of daily life among patients with SCI, including social interactions and body image. Participants described various coping strategies used to manage the physical and psychological demands associated with IC. These experiences appeared to be influenced by cultural considerations, including privacy, modesty and sensitivity surrounding urinary care within the local Saudi context.
Major depressive disorder (MDD) is a prevalent mental illness characterised by persistent sadness, loss of interest in activities and cognitive impairment. While pharmacological and psychotherapeutic treatments remain the standard for MDD management, non-pharmacological interventions, such as aerobic exercise, have gained attention for their potential benefits in reducing depressive symptoms and improving quality of life. Although several studies have explored the effectiveness of aerobic exercise in managing MDD, there is still no comprehensive synthesis of the existing evidence. This study aims to synthesise existing evidence on the effects of aerobic exercise interventions in the management of individuals diagnosed with MDD.
The systematic review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. A comprehensive search will be conducted across Cochrane, Medline, PEDro, CINAHL, Scopus, Web of Science and BioMed Central databases. Search terms will be developed using the Population, Intervention, Comparison, Outcome and Study design (PICOS) framework, incorporating keywords and Medical Subject Headings related to ‘Major Depressive Disorder’, ‘Aerobic Exercise’, ‘Depression’, and ‘Quality of Life’. Only intervention studies, including randomised controlled trials, quasi-experimental and pre–post intervention studies, will be included involving adults aged 18 years or older diagnosed with MDD according to standardised criteria (eg, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition and International Statistical Classification of Diseases and Related Health Problems -10 (ICD-10)). For included intervention studies, the comparator will be standard care, placebo or no-exercise control groups. The primary outcome is change in depressive symptoms, and secondary outcomes include quality of life, anxiety and stress-related biomarkers. Three independent reviewers will screen studies, extract data using Covidence software (Veritas Health Innovation in partnership with Cochrane) and assess study quality using the updated Cochrane Risk of Bias 2.0 (Rob-2) tool alongside the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. If feasible, a meta-analysis will be conducted using RevMan V.5.4 (Cochrane's Review Manager), with effect sizes determined by mean differences, standardised mean differences or ORs, depending on the outcome type. This study is currently at the proposal stage, with article searches expected to begin in November 2025 and data extraction anticipated to be completed by January 2026.
No ethical approval is required as this review uses existing published data. Findings will be disseminated through a peer-reviewed journal and presented at academic conferences.
CRD420251151897.
To summarise the evidence on long-term and infrequent harms following selected spinal and paraspinal injections and denervation procedures for chronic non-cancer spine pain.
Systematic review and meta-analysis.
MEDLINE, EMBASE and Cumulative Index to Nursing and Allied Health Literature from inception to October 2023.
Non-randomised studies reporting on harms of selected interventional procedures administered to adults living with chronic axial or radicular non-cancer spine pain with ≥4 weeks of follow-up.
A parallel guideline panel provided input on the scope, design and interpretation of this systematic review, including selection of adverse events for consideration. Systematic literature screening, data abstraction and risk of bias appraisal were conducted independently and in duplicate by pairs of reviewers. We used random-effects models for all meta-analyses and the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the certainty of evidence.
We included 60 longitudinal studies (56 non-comparative, 4 comparative) that enrolled 4966 patients with chronic non-cancer spine-related pain. 31 studies investigated radiofrequency ablation or denervation, 22 epidural injections and 11 joint injections or nerve blocks. Low certainty evidence suggests that joint targeted steroid injection and epidural steroid injection for chronic spine pain may result in temporary altered level of consciousness (incidence: 2.1%; 95% CI 1.1% to 4.0%), joint radiofrequency nerve ablation, joint targeted steroid injection and epidural injection of local anaesthetic and steroids may result in deep infection (incidence: 0.7%; 95% CI 0.3% to 2.0%), epidural steroid injection, joint radiofrequency nerve ablation and joint targeted injection of local anaesthetic and steroids may result in dural puncture (incidence: 1.4%; 95% CI 0.5% to 4.3%), and dorsal root ganglion radiofrequency and joint radiofrequency nerve ablation with or without joint-targeted injection of steroids may result in prolonged pain or stiffness (incidence: 8.6%; 95% CI 6.3% to 11.6%). Several interventional procedures may result in metabolic complications and prolonged sensory deficits, but the supporting evidence was only very low certainty. Most complications resolved spontaneously or with conservative management.
Low certainty evidence suggests that several common interventional procedures for chronic spine pain show risk of deep infection, dural puncture, temporary altered level of consciousness and prolonged pain or stiffness. Other harms are uncertain due to very low certainty evidence, and catastrophic outcomes were not reported in the small studies that contributed to our analyses.
Poststroke cognitive impairment (PSCI) is a prevalent complication of stroke, characterised by deficits in one or more cognitive domains (eg, memory, attention, executive function). Beyond increasing mortality and disability risks, PSCI frequently co-occurs with motor dysfunction, which impairs activities of daily living and reduces quality of life. Due to the complexity of neural networks involved in PSCI, clinical practice currently lacks targeted therapeutic strategies; existing interventions (eg, pharmacotherapy, traditional cognitive training) are limited in scope and variable in efficacy. Here, we developed an innovative dynamic cognitive training system integrated with virtual reality (VR) technology, based on principles of neuroplasticity and multisensory integration. This study aimed to explore the intervention effects of this system on cognitive function in patients with PSCI while incorporating exploratory neuroimaging assessments to provide descriptive and hypothesis-generating information regarding brain functional changes associated with the intervention.
This single-centre, randomised controlled, evaluator-blinded clinical trial will assess the rehabilitative efficacy of VR-based cognitive training in patients with PSCI. A total of 60 patients who had a stroke will be enrolled and randomised to either a conventional rehabilitation group or a VR intervention group. The intervention will last 2 weeks, with five sessions of 60 min each training session per week. During the 60-minute training session, both groups will receive 30 min of conventional rehabilitation training. For the remaining 30 min, the control group will undergo traditional cognitive rehabilitation while the experimental group will be subjected to VR-based cognitive rehabilitation training. The primary outcome measure is the Montreal Cognitive Assessment; secondary outcomes include the Mini-Mental State Examination, Trail Making Test and Stroop Test. Assessments will be conducted at three time points: baseline (T0), immediately postintervention (T1) and 4 weeks after completing the intervention (T2). This study aims to evaluate the preliminary effectiveness of a VR-based intervention in improving multidimensional cognitive function, while incorporating exploratory neuroimaging outcomes to generate hypothesis-forming insights into potential neural correlates.
The trial was approved by the Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (2025–1933-273-02).
The results will be submitted to a peer review journal or at a conference.
ChiCTR2600116040.
Balance impairment is a major contributor to falls, reduced mobility and loss of independence in individuals after stroke. Vibration therapy (VT) has been increasingly investigated as a non-invasive intervention to improve postural control and balance in individuals with stroke. However, the reported effects remain inconsistent, and a comprehensive synthesis focusing specifically on balance-related outcomes is lacking. This review aims to evaluate the effectiveness of VT on balance function and to explore the influence of intervention characteristics and outcome constructs.
This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. Randomised and non-randomised controlled studies will be systematically identified from major electronic databases. Balance-related outcomes will be categorised using a predefined construct-based framework (eg, static postural control, dynamic balance, limits of stability, functional mobility and gait performance). Meta-analyses will be conducted only within conceptually homogeneous constructs; otherwise, findings will be synthesised narratively. Risk of bias will be assessed using Cochrane Risk of Bias 2 and Risk of Bias in Non-randomised Studies of Interventions. Random-effects models will be applied where appropriate, and meta-regression analyses will be exploratory.
Ethical approval is not required because this study will use only previously published data and will not involve individual-level human participant data. The findings will be disseminated through publication in a peer-reviewed journal and presentation at relevant academic conferences.
CRD420251110102.
Postoperative pulmonary complications affect approximately 40% of individuals undergoing lung cancer surgery. A number of clinical trials and meta-analyses have shown that postoperative telehabilitation may reduce the incidence of postoperative adverse events while reducing transport time and outpatient costs and improving patient motivation. However, optimal telehabilitation strategies remain undetermined. The primary objective of this protocol is thus to compare the effects of different telehabilitation methods used after pulmonary surgery in patients with lung cancer by conducting a network meta-analysis.
Two researchers will independently search six databases (PubMed, the Cochrane Library, Embase, Web of Science, Medline and the Chinese National Knowledge Infrastructure (CNKI)) and two clinical trial registries (ClinicalTrials.gov and WHO ICTRP). The time range will be from database inception to March 2026. EndNote X V.21 will be used for screening based on predetermined inclusion criteria. All Chinese and English randomised controlled trials examining the effects of telehabilitation on lung function after lung cancer surgery will be included. The primary outcome measures will be forced vital capacity (FVC), forced expiratory volume over 1 s (FEV1), FEV1/FVC and 6 min walking test. The secondary outcome measures will be the incidence of adverse events, intervention completion rate, incidence of postoperative pulmonary complications and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score. Risk of bias assessment will be performed using the Cochrane Risk of Bias V.2 (RoB V.2.0) tool, while certainty of evidence will be evaluated using the Grading of Recommendations Assessment and Evaluation (GRADE). Stata V.18.0 (StataCorp, College Station, Texas) and R (V.4.1.2) will be used to conduct traditional pairwise meta-analysis and network meta-analysis.
Ethical approval is not required for this study. The results will be submitted to a peer-reviewed journal or conference.
CRD420251275899.
Pain experienced during functional activities, referred to as movement-evoked pain (MEP), is a common and disabling symptom in individuals with knee osteoarthritis (KOA). Unlike pain at rest, MEP may better reflect the real-life burden of KOA and is increasingly recognised as a core outcome in musculoskeletal pain trials. However, its clinical utility remains limited by a lack of evidence on its measurement properties. This study aims to evaluate the test-retest reliability and validity of MEP assessments during functional tasks in individuals with KOA.
This study includes two components: (1) a test-retest reliability assessment conducted over two sessions separated by approximately 7 days and (2) a cross-sectional analysis of convergent validity. We will recruit 62 participants with symptomatic KOA from the local communities. MEP will be assessed using an 11-point Numeric Rating Scale during five standardised functional tasks: 30-Second Chair Stand Test, One-Step Stair Climb Test, 40m Fast-Paced Walk Test, Timed Up and Go Test and Six-Minute Walk Test. Test-retest reliability will be evaluated using intraclass correlation coefficients (ICC3,1). Convergent validity will be assessed separately for each functional task by calculating correlation coefficients between MEP ratings and the pain subscale of the Knee injury and Osteoarthritis Outcome Score.
This study was approved by the Ethics Committee from Shanghai University of Sport (Ref: 102772025RT193). The study protocol was registered on the Open Science Framework (10.17605/OSF.IO/B9N7G). The findings will be disseminated through presentations at national and international scientific conferences and submitted for publication in a peer-reviewed journal.
This study aimed to (1) examine if activity fluctuations over 1 week differ between two groups: individuals who have received fatigue management advice versus those who have not, (2) examine the associations between activity fluctuations and fatigue, engagement in pacing, perceived risk of overactivity, quality of life, self-regulation and physical activity (PA) and if they differ for the two groups and (3) explore whether there are distinct pacing patterns across the week in adults with chronic conditions.
Exploratory cross-sectional observational study.
Participants were recruited from a fatigue management clinic in the UK and through university networks.
29 adults with chronic conditions who experience fatigue (18 received fatigue management advice; 11 did not).
The primary outcome was activity fluctuations (SD of accelerometer-derived vector magnitude counts per minute), measured using the ActiGraph wGT3X-BT over 7 consecutive days. Secondary outcomes included fatigue (Fatigue Severity Scale), engagement in activity pacing, perceived risk of overactivity, quality of life (Functional Assessment of Cancer Therapy-General Instrument), self-regulation of PA (Physical Activity Self-Regulation scale) and self-reported PA (International Physical Activity Questionnaire-short form).
No difference in activity fluctuations during the day was found between groups. Associations between self-regulation of PA and device-based PA with activity fluctuations significantly differed between groups (respectively, standardised regression (β)=1686.14; p=0.006 and β=288.83; p=0.042). Five distinct activity pacing patterns were identified through visual inspection of individual activity profiles: (1) high fluctuations in the morning, (2) high fluctuations in the afternoon, (3) high fluctuations at two time points, (4) consistent pacing pattern and (5) varied pacing patterns.
Individuals who received fatigue management advice demonstrated significant associations between activity fluctuations and self-regulation, suggesting a goal-directed approach, which could indicate that tailored support and goal setting could help in balancing rest and activity. This study also identified five distinct activity pacing patterns in individuals with chronic conditions, emphasising the need for tailored fatigue management instead of a ‘one-size-fits-all’ approach.
This scoping review intended to map the existing literature on chronic stroke rehabilitation interventions in primary healthcare (PHC) settings, with a particular focus on intervention dosage—frequency, intensity, type and duration—as well as the mode of delivery, which encompasses intervention location, format and provider.
A scoping review was conducted following the guidelines outlined in the Joanna Briggs Institute Manual for Evidence Synthesis.
A comprehensive search of 16 databases was conducted on the EBSCOhost platform on 10 February 2022. A supplementary Google search was conducted to identify grey literature up to 19 November 2022.
Sources published in English between 2010 and 2022 with full-text availability, addressing interventions for chronic stroke survivors delivered by various stakeholders in PHC, community or home-based settings.
Two reviewers independently screened the identified sources to determine eligibility for inclusion. Data were extracted independently, compared between reviewers, analysed and synthesised narratively with descriptive statistics.
In total 34 sources are included in the review, with most (n=28) originating from high-income countries. Interventions predominantly targeted the body function and structure component of the International Classification of Functioning, Disability and Health framework (n=29) through physical exercise (n=21). However, few interventions addressed the activity (n=17) and participation (n=11) components. Contextual factors (n=9) were seldom considered in intervention design. Intervention dosage varied widely. Most interventions were delivered by the multidisciplinary team (n=9) and were provided either at home (n=16) or in the community (n=13). Individual sessions (n=18) were more commonly offered than group sessions (n=8).
The optimal dosage for chronic stroke interventions remains uncertain, and current interventions, along with their modes of delivery, are often misaligned with PHC settings. Further research is essential to establish best practices in both well-resourced and under-resourced environments to address the current evidence gap and to enable the development of effective rehabilitation protocols that meet the needs of chronic stroke survivors and their families in PHC settings.
Spinal cord injury (SCI) impairs autonomic functions, which are ranked among the highest priorities for recovery. The loss of autonomic control, including bowel, bladder, sexual and cardiovascular functions, interferes with rehabilitation and decreases health-related quality of life (HRQoL). Preliminary evidence indicates that non-invasive transcutaneous spinal cord stimulation (TCSCS) has the potential to improve autonomic stability in people with SCI. However, the optimal stimulation site for improving autonomic responses remains to be determined. This pilot randomised clinical trial aims to explore the efficacy of non-invasive mid-thoracic and lumbosacral TCSCS (proof-of-concept) for blood pressure stability (orthostatic hypotension and autonomic dysreflexia burden) alongside end-organ autonomic functions (lower urinary tract, bowel and sexual function) and HRQoL.
30 participants with chronic (>1 year) motor-complete SCI (American Spinal Injuries Association Impairment Scale A and B) at or above T6 will be enrolled in this open-label, two-arm randomised pilot clinical trial. Participants will be block randomised into either the mid-thoracic or lumbosacral TCSCS group. Participants will then undergo 8 weeks of TCSCS (3 times per week for 60 min; 24 sessions total) while in a seated position. Post-treatment effects will be recorded following the 8-week intervention and follow-up effects will be recorded 8 weeks after the end of the intervention. Primary and secondary outcomes will assess resting blood pressure, autonomic dysreflexia, orthostatic hypotension and lower urinary tract, bowel and sexual functions as well as HRQoL.
This study is approved by The University of British Columbia’s Clinical Research Ethics Board (UBC CREB H22-00365), and by Health Canada for Investigational Testing Authorisations (ITA) for Class II medical devices used in this trial (ITA#346875 TESCoN; ITA#381 154 SCONE). The findings will be disseminated through peer-reviewed publications, conferences, seminars and SCI community outreach.
Stroke is the leading cause of death and disability among adults in China, with a growing disease burden. Data from the China Stroke Prevention and Treatment Report 2023 show that the incidence rate of stroke in China is approximately 246.8 per 100 000 population, with over 2 million new cases annually. Among surviving patients, 60%–70% experience varying degrees of hand dysfunction after discharge, and only 10%–20% can recover to near-normal levels. As the most refined and core motor function of the human body, hand function recovery essentially reflects motor cortical neuroplasticity (synaptic remodelling and cortical reorganisation). Its recovery directly affects the independence of activities of daily living (ADLs) such as eating, dressing and personal hygiene, markedly reducing quality of life and increasing family care burden and social medical costs.
Currently, clinical rehabilitation interventions for patients who had a stroke are mostly concentrated during hospitalisation, focusing on acute-phase stability and basic function recovery. However, postdischarge rehabilitation follow-up coverage is fewer than 40%, and community rehabilitation resources are disparately distributed, leaving most patients facing the dilemma of ‘interrupted rehabilitation after discharge’. Additionally, existing studies mostly focus on short-term follow-up (3–6 months) and lack systematic investigation of the long-term trajectory of hand function recovery (6 months to 1 year), key turning points and influencing factors—especially the regulatory role of multidisciplinary intervention on neuroplasticity. The integrated ‘hospital-community-family’ multidisciplinary collaborative management model remains underdeveloped.
This study aims to describe the dynamic trajectory of hand function and overall rehabilitation outcomes in patients who had a stroke at 6 months and 1 year postdischarge, analyse the key influencing factors of hand function recovery (with a focus on the regulatory role of multidisciplinary collaborative intervention on motor cortical neuroplasticity), verify the effectiveness of the multidisciplinary collaborative management model on complications and rehabilitation satisfaction, and ultimately construct a continuous rehabilitation management model adapted to the current status of primary medical care in China.
A single-centre, prospective cohort study design will be used. A total of 120 patients who had a stroke with hand dysfunction discharged from the Department of Rehabilitation Medicine, The Second People’s Hospital of Hefei Guangde Road Campus between February 2026 and February 2027 will be enrolled. A multidisciplinary team (MDT) consisting of rehabilitation physicians, rehabilitation therapists, community doctors/nurses and family caregivers will be established to implement a three-stage intervention: discharge connection, community intervention and online support (incorporating neuroplasticity initiation, enhancement and maintenance strategies).
Hand function (primary outcome) will be assessed using the Fugl-Meyer Assessment for Hand (FMA-Hand) at baseline (1–3 days predischarge, T0), 3 months postdischarge (T1), 6 months postdischarge (T2) and 12 months postdischarge (T3). Secondary outcomes include overall motor function (FMA Total Score, FMA-Total) and ADL (Modified Barthel Index). Influencing factor data will be collected using structured questionnaires, and neuroplasticity will be indirectly evaluated using transcranial magnetic stimulation-derived motor evoked potentials.
SPSS V.26.0 software will be used for statistical analyses. Quantitative data will be expressed as (x±s) or (M (IQR)) depending on normality; categorical data will be presented as (n (%)). Repeated measures analysis of variance will compare functional changes across time points, and multiple linear regression will identify independent influencing factors of hand function recovery.
Patients will show progressive hand function recovery within 1 year after discharge, with the fastest recovery at 3–6 months and stabilisation from 6 to 12 months. Younger age, higher baseline function, better rehabilitation adherence and active multidisciplinary intervention are associated with greater neuroplasticity and better hand function recovery. The MDT model may reduce complications and improve rehabilitation satisfaction and ADL.
The results of this study will fill the data gap in long-term postdischarge rehabilitation trajectories of patients who had a stroke, clarify the regulatory role of multidisciplinary collaborative intervention on motor cortical neuroplasticity and provide scientific evidence and practical references for optimising postdischarge rehabilitation follow-up programmes and improving the primary rehabilitation service system.
This study was approved by the Biomedical Research Ethics Committee of The Second People’s Hospital of Hefei (No. 2024-KY-089). Written informed consent was obtained from all participants. The results will be published in peer-reviewed journals and disseminated to participants and community health institutions.
ChiCTR2600119007.
Adolescent idiopathic scoliosis (AIS) requires long-term conservative management to prevent curve progression. While physiotherapeutic scoliosis-specific exercises, specifically the Schroth method, are considered the gold standard for conservative treatment, their clinical efficacy is often limited by accessibility barriers, high costs and suboptimal treatment adherence. This study aims to evaluate the efficacy of a novel artificial intelligence (AI)-based digital therapeutic system, which uses computer vision for remote, personalised posture analysis and adaptive exercise prescription compared with traditional outpatient Schroth therapy.
This parallel-group randomised controlled trial will be conducted at Guangzhou Women and Children’s Medical Center (Guangzhou, China). 300 adolescents aged 10–18 years with AIS who present with a Cobb angle between 10° and 30° and a Risser sign of 0–2 will be recruited and randomised in a 1:1 ratio into an intervention group and a control group. The intervention group will use a smartphone application to capture standardised bi-weekly images. These images will be processed by an AI algorithm to classify curve patterns and assign personalised exercise modules with adaptive dosing ranging from maintenance to high-intensity levels. The control group will receive standard outpatient Schroth care. The primary outcome is the absolute change in the major curve Cobb angle from baseline to 6 months. Secondary outcomes include the angle of trunk rotation, trunk appearance perception, Scoliosis Research Society-22 Revised (SRS-22r) quality-of-life scores and adherence rates. Statistical analysis will follow the intention-to-treat principle using linear mixed models to account for repeated measures.
Ethical approval has been obtained from the Medical Ethics Committee of Guangzhou Women and Children’s Medical Center (Guangzhou, China) (approval no. [2025]497A01). Written informed assent and consent will be obtained from participants and their legal guardians respectively. Results will be disseminated through peer-reviewed journals and international conferences.
ClinicalTrials.gov, NCT07341633.
Diabetic foot ulcers (DFUs) are a complication of uncontrolled and long-standing diabetes, often associated with peripheral neuropathy, and can result in amputation, prolonged hospitalisation and reduced quality of life. Orthotic insoles are commonly used to redistribute plantar pressure, offload the ulcer site and potentially accelerate wound healing. This systematic review aims to evaluate the effectiveness of offloading insoles in the healing of DFUs, with a focus on ulcer size reduction, recovery time, pain management, pressure redistribution and limb function, such as balance. A secondary objective is to compare the effects of different insole materials on healing outcomes, including satisfaction level towards the insole and overall quality of life.
A comprehensive literature search will be conducted in PubMed, MEDLINE, CINAHL and Google Scholar. Randomised controlled trials (RCTs) will be prioritised, while non-randomised studies that meet the eligibility criteria will also be considered. Studies published in English between 2000 and 2026 will be included. Eligible studies must assess the impact of orthotic insoles on DFUs, with outcome measures including pain intensity, pressure redistribution, wound healing and recovery time. Methodological quality will be assessed using the PEDro scale, while the Cochrane Risk of Bias tool (RoB 2) and the Risk of Bias in Non-randomised Studies of Interventions (ROBINS-I) will be applied as appropriate. Data will be extracted using a standardised form.
This review does not require ethical approval. The results will be shared through publications in peer-reviewed journals and conference presentations.
CRD420251145215.
In recent years, virtual reality (VR) training has gained momentum in stroke rehabilitation for reducing falls by enhancing balance and stability.
VR interventions offer superior immersion, interactivity and creative engagement compared with conventional therapies. However, the precise mechanisms by which VR influences dynamic stability remain unclear. Moreover, there is currently limited information regarding user experience (UX) in this context.
This study protocol outlines a randomised controlled trial designed to evaluate the effects of an immersive VR intervention on the dynamic stability of gait parameters in stroke survivors, incorporating an assessment of UX. Two groups of subjects will be enrolled in this study, including patients with a stroke within the previous 6–12 months who will receive (1) 3 weeks of immersive VR training (intervention) or (2) conventional rehabilitation (control).
The primary outcome of the study will be dynamic stability measures and the UX. The secondary outcomes include anxiety and depression, fatigue, functional mobility, functional walking ability, static balance, fear of falling and adverse effects. All participants will be assessed at baseline, after 3 weeks and after 2 months of the initiation of the study.
The study ethics were approved by the ethical committee of Tehran University of Medical Sciences (registration No IR.TUMS.NI.REC.1401.091, registered on 8 January 2023). Written consent is going to be taken from all of the participants. The study adheres to the principles outlined in the Declaration of Helsinki. Dissemination of study findings will occur through peer-reviewed publications and knowledge translation activities targeting clinicians, researchers and rehabilitation professionals. Data generated from this study will be anonymised and curated in accordance with institutional and national data protection standards
IRCT20231031059916N1.
Anomia is a primary feature of aphasia that negatively impacts quality of life. Although current anomia treatments improve word retrieval, long-term retention and generalisation of trained words to discourse-level communication are rarely measured. Treatment that produces lasting naming gains and generalises to real-world use is one of the top priorities of people living with aphasia. Here, we report the protocol for a randomised clinical trial that investigates individualised anomia treatment through adaptive naming deadlines to achieve ‘desirable difficulty’ to promote learning retention and generalisation.
We implement a within-subject sequential, crossover design in which 30 participants with chronic post-stroke aphasia will complete three anomia treatment conditions in randomised order: (1) an adaptive condition where the naming deadline (ie, amount of time the participant is given to name the item) dynamically adjusts between 1.5 and 10 s based on ongoing participant performance and (2) a static Effort-Maximised condition where there is a fixed 10-second naming deadline for all treatment sessions and (3) a static Accuracy-Maximised condition where items are presented immediately in auditory and orthographic form and are repeated by the participant. In each condition, participants are treated on 40 unique non-overlapping words across eight treatment sessions. Before and after each condition, participants complete naming probes and discourse probes. Treatment outcomes from the adaptive treatment will be tested against the two static conditions using linear mixed-effects modelling. Our primary outcome is performance on noun picture naming at 3 months post-treatment. We evaluate production of treated words in discourse probes as a secondary analysis. We predict that our novel, adaptive naming treatment will produce more successful outcomes compared with the static treatment conditions.
The Institutional Review Board of the University of Pittsburgh approved the trial protocol (Study 21120130). Following study completion, results will be disseminated in peer-reviewed journals. If hypothesised results are observed, the adaptive treatment will be a novel, empirically based intervention for long-term retention of anomia treatment gains, positively impacting the lives and recovery of individuals living with aphasia.
The Comprehensive High-dose Aphasia Treatment (CHAT) programme is an intensive comprehensive aphasia programme, which aims to address evidence-practice gaps in aphasia rehabilitation where there are known barriers to service delivery requiring implementation strategies. The aims of this study are to (1) evaluate the clinical implementation of the CHAT programme, (2) assess the clinical effectiveness of CHAT compared with usual care in rehabilitation services and (3) determine whether the real-world implementation of CHAT compared with usual care is cost-effective.
Four participant groups will be recruited across six hospital and health services Australia-wide to participate in a type 3 hybrid effectiveness-implementation study: (1) people with aphasia, (2) support persons, (3) treating clinicians and students and (4) clinical stakeholders (eg, managers). This before-and-after study will include three time periods: (1) ‘usual care’ where people with aphasia will receive their usual care aphasia therapy, (2) ‘implementation transition’ where clinicians will be trained to deliver CHAT and (3) ‘intervention implementation’ where people with aphasia will receive the CHAT programme (ie, 50 hours of evidence-based aphasia therapy over 8 weeks). Evidence-based implementation strategies will be used to facilitate implementation within participating rehabilitation services. The primary outcome is delivery of evidence-based aphasia treatment (ie, CHAT) as measured by a composite score of quality indicators. Clinical effectiveness outcomes, measuring change in language impairment, communication effectiveness, confidence and quality of life, and implementation outcomes will also be examined. We will also conduct an embedded mixed-methods process evaluation and economic evaluation.
This study has been approved by the Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC/2021/QRBW/72154). Outputs will include conference presentations, publications and a training package to optimise implementation of aphasia treatment in rehabilitation service contexts.
Australian New Zealand Clinical Trials Registry (ANZCTR) prospective registration ACTRN12621001765819. Trial registered 23 December 2021. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381365&isReview=true.
Rare skeletal disorders (RSDs) cause lifelong functional impairment, chronic pain and reduced quality of life. Evidence-based rehabilitation strategies remain underdeveloped, particularly for adolescents and young adults. We previously demonstrated preliminary feasibility of a 5-day adapted sailing intervention but observed benefit attenuation at 3-month follow-up. This pilot trial evaluates feasibility, acceptability and safety of intensive adapted sailing therapy followed by home-based telerehabilitation maintenance versus telerehabilitation alone.
This is a prospective, randomised, assessor-blinded, parallel two-arm pilot feasibility trial. 24 participants aged 12–30 years with confirmed RSDs will randomise with a 1:1 allocation ratio to: (1) 5-day adapted sailing therapy followed by 3-month telerehabilitation (n=12) or (2) 3-month telerehabilitation alone (n=12). Primary outcomes assess feasibility through recruitment efficiency (≥80% eligible patients enrolled), intervention adherence (≥75% sessions completed), participant retention (≥80% at 6-month follow-up), and safety (zero serious adverse events attributable to interventions). Secondary outcomes include sensor-based motor function (balance, gait, upper extremity mobility via inertial measurement units) and patient-reported outcomes (health-related quality of life, functional capacity, kinesiophobia, pain), measured at baseline, 3-month and 6-month follow-up. Exploratory analyses will estimate preliminary between-group effect sizes. Statistical analysis uses intention-to-treat principles with linear mixed-effects models.
The study received approval from the Area Vasta Emilia Centro Ethics Committee (363/2025/Sper/IOR) on 7 July 2025. The study is ongoing, and data collection is expected to be completed by March 2026. Results will be disseminated through peer-reviewed open-access publications, conference presentations, patient organisation partnerships and plain-language summaries.
Long covid affects a significant proportion of people following SARS-CoV-2 infection and is associated with persistent symptoms such as fatigue, cognitive dysfunction and breathlessness which can negatively impact a person’s ability to return to and remain in work. Although tiered vocational rehabilitation (VR) models have been proposed, these are often generic, lack empirical validation and may not address the complex, fluctuating needs of this population.
To co-design a VR intervention (the COVID-19-VR intervention) to support return to work (RTW) for people with long covid (pwLC).
Primary and secondary care.
Mixed-methods target population-centred, person-based approach in three stages: Stage 1: interviews (n=21) with pwLC to identify issues and challenges faced in working with long covid. Stage 2: three co-design workshops with pwLC and service providers to (a) generate guiding principles, (b) identify key intervention features to address work needs, (c) create a logic model to illustrate how the intervention could work and (d) develop a treatment plan and resources. Stage 3: feasibility and acceptability testing in six cases (three critical care admissions, three primary care referrals).
PwLC described work-related problems relating to: fluctuating symptoms (cognition, fatigue and breathlessness), employer, coworker and family’s understanding of long covid and workplace adjustments. We developed a 6-session, 12-week individually tailored, remotely delivered intervention that included vocational goal setting, RTW planning, fatigue/symptom management, financial advice, and where permitted, education for family/employers, employer engagement and negotiation of a phased RTW. Following feasibility testing, changes included accommodating the long-term nature of long covid, addressing unmet psychological needs, and adding content on adjustment, processing traumatic experience and performance/symptom anxiety, with extended delivery including monitoring, review and case coordination.
PwLC may need specialist help to RTW. Our COVID-19-VR appears feasible and acceptable and warrants further evaluation using a staged approach, prior to any definitive effectiveness trial.