Various treatment options are available for degenerative joint disease (DJD). During clinical visits, patients and clinicians collaboratively make decisions regarding the optimal treatment for DJD; this is the essence of shared decision-making (SDM). Here, we collated and assessed the SDM-related experiences and perspectives of outpatients with DJD in Taiwan.
In-depth interviews and thematic analysis.
Primary care clinics of a regional teaching hospital in Taiwan, October 2021–May 2022.
21 outpatients with at least three visits for DJD and who were aware of SDM.
Four main themes emerged in this study: first, equipping themselves with knowledge: outpatients obtained disease-related and treatment-related knowledge in various ways—seeking relevant information online, discussing with family and friends, learning from their own experiences or learning from professionals. Second, shared or not shared: physicians had different patterns for communicating with patients, particularly when demonstrating authority, performing mutual discussion, respecting patient preferences or responding perfunctorily. Third, seldom saying no to physician-prescribed treatment plans during clinical visits: most patients respected physicians’ professionalism; however, some patients rejected physicians’ recommendations indirectly, whereas some responded depending on their disease prognosis. Fourth, whose call?—participants decided to accept or reject a treatment plan independently or by discussing it with their families or by obeying their physicians’ recommendations.
In general, patients with DJD sought reliable medical information from various sources before visiting doctors; however, when having a conversation with patients, physicians dominated the discussion on treatment options. The patient–physician interaction dynamics during the SDM process determined the final medical decision, which was in accordance with either patients’ original autonomy or physicians’ recommendations. To alleviate medical paternalism and physician dominance, patients should be empowered to engage in medical decision-making and share their opinions or concerns with their physicians. Family members should also be included in SDM.
Key to improving outcomes for patients with multimorbidity is increasing mobility through prescription of a physical activity programme, but this can be difficult to achieve in acute hospital settings. One approach that would assist physiotherapists to increase levels of physical activity is delegation of rehabilitation to allied health assistants. We aim to conduct a randomised controlled trial to determine the feasibility of an allied health assistant providing daily inpatient mobility rehabilitation for patients with multimorbidity.
Using a parallel group randomised controlled design, participants will be allocated to allied health assistant mobility rehabilitation or physiotherapist mobility rehabilitation. Adult inpatients (n=60) in an acute hospital with a diagnosis of multimorbidity who walked independently preadmission will be included. The experimental group will receive routine mobility rehabilitation, including daily mobilisation, from an allied health assistant under the supervision of a physiotherapist. The comparison group will receive routine rehabilitation from a physiotherapist. Feasibility will be determined using the following areas of focus in Bowen’s feasibility framework: Acceptability (patient satisfaction); demand (proportion of patients who participate); implementation (time allied health assistant/physiotherapist spends with participant, occasions of service); and practicality (cost, adverse events). Staff involved in the implementation of allied health assistant rehabilitation will be interviewed to explore their perspectives on feasibility. Secondary outcomes include: Physical activity (daily time spent walking); daily mobilisation (Y/N); discharge destination; hospital readmission; falls; functional activity (Modified Iowa Level of Assistance Scale); and length of stay. Descriptive statistics will be used to describe feasibility. Secondary outcomes will be compared between groups using Poisson or negative binomial regression, Cox proportional hazards regression, survival analysis, linear regression or logistic regression.
Ethics approval was obtained from Peninsula Health (HREC/97 431/PH-2023). Findings will be disseminated in peer-reviewed journals and conference presentations.
Australian and New Zealand Clinical Trial Registry ACTRN12623000584639p.
Muscle strengthening training (MST) and behavioural graded activity (BGA) show comparable effects on knee osteoarthritic (KOA) pain, but the mechanisms of action remain unclear. Both exercise-induced anti-inflammation and central sensitisation are promising pathways for pain relief in response to exercise therapy in patients with KOA: MST has the potential to decrease inflammation and BGA has the potential to decrease central sensitisation. Hence, this study aims to examine inflammation and central sensitisation as mediators for the effect of MST and/or BGA on pain in patients with KOA.
The Knee OsteoArthritis PAIN trial started on 10 January 2020 (anticipated end: April 2024). The three-arm clinical trial aims to recruit 90 KOA patients who will be randomly allocated to 12 weeks of (1) MST, (2) BGA or (3) care as usual. Assessments will be performed at baseline, 13 and 52 weeks after finishing the intervention. Outcomes, including pain (Knee injury and Osteoarthritis Outcome Score), were chosen in line with the OARSI recommendations for clinical trials of rehabilitation interventions for OA and the IMMPACT/OMERACT recommendations for the assessment of physical function in chronic pain clinical trials. Inflammation as well as features of central sensitisation (including conditioned pain modulation, offset analgesia, temporal summation of pain and event-related potentials following electrical stimulation), will be considered as treatment mediators. A multiple mediators model will be estimated with a path-analysis using structural equation models. In July 2023, all 90 KOA patients have been included and 42 participants already finished the study.
This study obtained ethics approval (B.U.N. 143201941843). Unravelling the mechanisms of action of exercise therapy in KOA will not only be extremely valuable for researchers, but also for exercise immunology and pain scientists and clinicians.
Osteoarticular pain is experienced by approximately 50% of patients with breast cancer under hormone therapy and can increase the risk of therapy discontinuation. Among complementary therapies, yoga has shown efficacy regarding reduction of fatigue, anxiety, pain due to hormone therapy and inflammation. Personalised patient education programmes increase engagement and motivation, and induce effective behavioural changes. The SKYPE programme, an integrated intervention combining physiotherapy, yoga and patient education, showed promising efficacy on hormone therapy-induced pain in a previous pilot study. In this study, we hypothesised that using theory-based patient education favour learning and practising 15 min of at-home yoga every day to decrease hormone therapy-induced pain.
This multicentre randomised study will assess the efficacy of the SKYPE programme on pain reduction compared with standard care in patients with breast cancer reporting osteoarticular pain due to hormone therapy. Main secondary objectives will describe pain evolution and characteristics, patient adhesion to yoga sessions and home practice, forward flexibility, quality of life, fatigue, anxiety and compliance to hormone therapy. Patients in the intervention group will participate in 1 weekly educational yoga session of 90 min for 6 weeks, supervised by physiotherapists (period 1). They will also perform daily at-home 15 min yoga sessions for 12 weeks, the total duration of the intervention (periods 1 and 2). Pain will be evaluated during physiotherapy check-ups at baseline (T0), at 6 weeks (T1) and at 12 weeks (T2).
This study was approved by the ethics committee (CPP Ile de France 8 on 22 June 2020). The results will be disseminated to patients and healthcare professionals, and published in a peer-reviewed journal.
Patient-reported outcome measures (PROMs) are required for patient-centred care. There are limited PROMs with good psychometric properties, and limitations to any language-based scale are often constrained by the written words or numerals used. Therefore, we developed the Functional Activity Scoring Tool (FAST), a self-reporting pictorial scale. FAST measures the impact of knee osteoarthritis on essential activities of daily living (ADL) and the significant changes in the self-perceived functional status over time.
This study aims to (1) develop FAST with adaptation from the Wong-Baker FACES pain rating scale, (2) validate FAST against the Patient-Specific Functional Scale (PSFS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) and (3) establish the reliability, validity and responsiveness of FAST in individuals with knee osteoarthritis.
The prospective study protocol investigates the validity, responsiveness and reliability of FAST. The PSFS and KOOS will be gold standard comparisons. Participant recruitment will occur at four public polyclinics that offer physiotherapy outpatient services in Singapore. Onsite physiotherapists familiar with the study eligibilities will refer potential participants to the investigators after the routine physiotherapy assessment. After providing written consent, eligible participants will complete outcome measurements with FAST, the PSFS and KOOS during baseline and follow-up assessments. The Global Rating of Change (GROC) scale will determine how the participant’s knee status was changed compared with the beginning of the physiotherapy intervention.
SingHealth Centralised Institutional Review Board approved the study (CIRB reference number: 2022/2602). The final results will be published via scientific publication. FAST will benefit the evaluation and management of those who suffer knee osteoarthritis regardless of English proficiency or language barriers.
Long head of biceps brachii tendinopathy (LHBT) is characterised by persistent pain and disability of shoulder joint, impairing patients’ quality of life. Extracorporeal shock wave therapy (ESWT) is a non-invasive treatment, which promotes tissue regeneration and repair. However, ESWT has a side effect that often causes short-term pain and swelling in the treatment area. It is known that the effects of Kinesio taping (KT) on relieving swelling and pain. Due to insufficient clinical evidence from current limited studies, this randomised controlled study aims to explore the effects of ESWT combined with KT on upper limb function during individuals with LHBT.
A 2x2 factorial design, double-blind, randomised controlled trial will be conducted. A total of 144 participants will be randomly allocated into one of four groups (KT+ESWT, KT+sham ESWT, sham KT+ESWT or sham KT+sham ESWT) to participate in a 4-week treatment programme. Measurements will be taken at pretreatment (baseline), immediately after treatment and 6 weeks after treatment. The primary endpoint will be the Constant-Murley score (CMS), the secondary endpoints will include the pain Numerical Rating Scale, range of motion, pressure pain threshold and soft tissue hardness of biceps, speed test and global rating of change. Repeated measures analysis of variance will be used to compare differences among the effects of different interventions.
Ethics approval was obtained from the Ethics Committee of the Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. In addition to international conference reports, findings will be disseminated through international publications in peer-reviewed journals.
ChiCTR2100051324.
Rotator cuff calcific tendinopathy (RCCT) involves calcific deposits in the rotator cuff. Non-surgical interventions such as extracorporeal shockwave therapy (ESWT) and ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) are recommended for its early management. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been formally tested in RCCT. The main objective of this study is to compare the effectiveness of an ET programme with ESWT and US-PICT in people with RCCT. As a secondary aim, this study aims to describe the natural history of RCCT.
A randomised, single-blinded four-group clinical trial will be conducted. Adults from 30 to 75 years diagnosed with RCCT who accomplish eligibility criteria will be recruited. Participants (n=116) will be randomised into four groups: ET group will receive a 12-week rehabilitation programme; ESWT group will receive four sessions with 1 week rest between sessions during 1 month; US-PICT group will receive two sessions with 3 months of rest between sessions; and (actual) wait-and-see group will not receive any intervention during the 12-month follow-up. The primary outcome will be shoulder pain assessed with the Shoulder Pain and Disability Index at baseline, 2 weeks, 4 months, 6 months and 12 months from baseline. The primary analysis will be performed at 12 months from baseline. Secondary outcomes will include pain, range of motion, patient satisfaction and imaging-related variables. Moreover, the following psychosocial questionnaires with their corresponding outcome measure will be assessed: Central Sensitization Inventory (symptoms related to central sensitization); Pain Catastrophizing Scale (pain catastrophizing); Tampa Scale for Kinesiophobia 11 items (fear of movement); Fear Avoidance Belief Questionnaire (fear avoidance behaviour); Hospital Anxiety and Depression Scale (anxiety and depression); Pittsburgh Sleep Quality Index (sleep quality); and the EuroQol-5D (quality of life). An intention-to-treat analysis will be performed to reduce the risk of bias using a worst-case and best-case scenario analysis.
Ethics committee approval for this study has been obtained (reference number: 1718862). The results of the main trial will be submitted for publication in a peer-reviewed journal.
With the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, children with developmental coordination disorder learn to use a problem-solving strategy to deal with their motor difficulties and perform daily activities of their choice. Therapists use guided discovery to enable children to find their own solutions. Although CO-OP is recommended in a group setting, studies are needed to support its effectiveness.
A single-case study design with multiple baselines across participants and four systematic replications will be used. In each of the five groups, four children (aged 8–12 years) will be randomly included at the baseline. The baseline includes 5–8 measurements, and the CO-OP intervention stage is comprised of 10 sessions. The follow-up stage includes five measurements. Prior to baseline, each child in each of the five groups will choose five activities of which three will be carried out during the intervention sessions. Children’s performance in each of these activities will be scored using the Performance Quality Rating Scale (PQRS) as the main measure. Three secondary measures will be collected: perceived activity performance using the Canadian Occupational Performance Measure, quality of life using the Kidscreen-27 and spontaneous motor rhythm using a computerised typing task. Graphed data will be analysed visually at the individual level with the Visual Aid Implying an Objective Rule (VAIOR) protocol which provides a colour code based on the level and trend of two consecutive phases, facilitating an objective visual analysis. Statistics will be performed for PQRS scores at the individual level and at the group level.
The protocol has been approved by the Comité de protection des personnes Sud-Est I (CPP 2021070) and the Comité d’éthique de la recherche avec les êtres humains de l’Université du Québec à Trois-Rivières (CER-22-294-07.03). Results will be published in a peer-reviewed scientific journal.
Perioperative rehabilitation (PORT) has shown a positive effect on patients undergoing cardiac surgery. However, there are minimal data on the impact of short-term PORT in cardiac surgery, which is associated with higher postoperative morbidity and mortality. The trial will assess the efficacy of short-term PORT in reducing in-hospital mortality, postoperative pulmonary complications and length of stay, compared with the usual care in cardiac surgical patients.
This is a single-centre prospective, randomised, open, controlled trial with a 1:1 ratio. Consecutive 800 adult patients undergoing elective valve surgery will be randomised to either usual care or in-hospital short-term PORT that consists of education, inspiratory muscle training, active cycle of breathing techniques and early mobilisation. The primary outcome of this study will be a composite of in-hospital all-cause mortality, incidence of postoperative pulmonary complications and the ratio of postoperative hospitalisation >7 days.
The PORT study was granted by the Medical Research Ethics Committee of Guangdong Provincial People’s Hospital in August 2018. Findings will be disseminated to patients, clinicians and commissioning groups through peer-reviewed publication.
The ageing populations in developed countries are a global concern, with increasing numbers of older adults facing physical, cognitive and psychological challenges, resulting in reduced quality of life and higher healthcare costs. Healthcare expenditure worldwide has been on the rise, especially among older adults, emphasising the importance of enabling independent living while reducing healthcare costs. Occupational therapy holds promising outcomes in promoting functional independence and enhancing the quality of life for older adults, but research on its cost-effectiveness remains limited. This systematic review aims to evaluate the recent evidence on the cost-effectiveness of occupational therapy interventions for older adults from a pragmatic perspective.
This systematic review will cover full economic evaluations, including cost-effectiveness, cost-utility and cost–benefit analyses, by reviewing randomised and cluster randomised controlled trials. The participants will be aged over 65 years without disease or disability restrictions. Primary outcomes will be assessed using functional status and quality-of-life assessments. Studies published before July 2023 will be searched in PubMed, Web of Science and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases, with no language restrictions.
Ethical approval is not required for this literature-based systematic review. The study’s findings will update the evaluation of occupational therapy’s cost-effectiveness in older adults and will be made public by publishing them in scholarly journals.
CRD42023453558.
This study aimed to explore the perceptions and experiences of barriers and facilitators to accessing Long COVID community rehabilitation.
We used a qualitative descriptive design over two rounds of data collection with three participant groups: (1) people with experience of rehabilitation for Long COVID (PwLC); (2) National Health Service (NHS) staff delivering and/or managing community rehabilitation services (allied health professionals (AHPs)) and (3) NHS staff involved in strategic planning around Long COVID in their health board (Long COVID leads).
Four NHS Scotland territorial health boards.
51 interviews: eight Long COVID leads (11 interviews); 15 AHPs (25 interviews) and 15 PwLC (15 interviews).
Three key themes were identified: (1) accessing care for PwLC, (2) understanding Long COVID and its management and (3) strengths and limitations of existing Long COVID rehabilitation services.
Organisational delivery of Long COVID community rehabilitation is complex and presents multiple challenges. In addition, access to Long COVID community rehabilitation can be challenging. When accessed, these services are valued by PwLC but require adequate planning, publicity and resource. The findings presented here can be used by those developing and delivering services for people with Long COVID.
Repetitive transcranial magnetic stimulation (rTMS) is an evidence-based treatment widely recommended to promote hand motor recovery after ischaemic stroke. However, the therapeutic efficacy of rTMS over the motor cortex in stroke patients is currently restricted and heterogeneous. This study aimed to determine whether excitatory rTMS over the contralesional dorsal premotor cortex (cPMd) facilitates the functional recovery of the upper limbs during the postacute stage of severe ischaemic stroke.
This study will be conducted as a single-blind, controlled, randomised study, in which 44 patients with poststroke hemiplegia with a course of disease ranging from 1 week to 3 months and Fugl-Meyer upper limb score ≤22 will be enrolled. The study participants will be randomly assigned to groups A (n=22) and B (n=22). The two groups are based on routine rehabilitation training and drug treatment; group A will be treated with low-frequency (1 Hz) rTMS over the contralesional primary motor cortex (cM1), and group B will be treated with high-frequency (10 Hz) rTMS over cPMd. For 2 weeks, rTMS will be administered once a day, 5 days a week. The primary outcome is the Fugl-Meyer assessment of the upper limb. The secondary outcomes include the Arm Subscore of the Motricity Index, Hong Kong edition of Functional Test for the Hemiplegic Upper Extremity, Modified Barthel Index and Modified Ashworth Scale score of the paralysed pectoralis major and biceps brachii. Furthermore, data of diffusion tensor imaging and functional MRI will be collected. These outcomes will be assessed before and after the completion of the intervention.
This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (2020 SR-266). The findings of this study will be spread through networks of scientists, professionals and the general public as well as peer-reviewed scientific papers and presentations at pertinent conferences.
ChiCTR2000038049
To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery.
Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.
National Health Service (NHS) providers in five English hospitals.
Community-dwelling adults, aged 60 years and over, who undergo hip fracture surgery and their informal caregivers.
Usual care: usual NHS care. Experimental: usual NHS care plus a caregiver–patient dyad training programme (HIP HELPER). This programme comprised three, 1 hour, one-to-one training sessions for a patient and caregiver, delivered by a nurse, physiotherapist or occupational therapist in the hospital setting predischarge. After discharge, patients and caregivers were supported through three telephone coaching sessions.
Central randomisation was computer generated (1:1), stratified by hospital and level of patient cognitive impairment. There was no blinding.
Data collected at baseline and 4 months post randomisation included: screening logs, intervention logs, fidelity checklists, acceptability data and clinical outcomes. Interviews were conducted with a subset of participants and health professionals.
102 participants were enrolled (51 patients; 51 caregivers). Thirty-nine per cent (515/1311) of patients screened were eligible. Eleven per cent (56/515) of eligible patients consented to be randomised. Forty-eight per cent (12/25) of the intervention group reached compliance to their allocated intervention. There was no evidence of treatment contamination. Qualitative data demonstrated the trial and HIP HELPER programme was acceptable.
The HIP HELPER programme was acceptable to patient–caregiver dyads and health professionals. The COVID-19 pandemic impacting on site’s ability to deliver the research. Modifications are necessary to the design for a viable definitive RCT.
Although task-oriented training (TOT) may provide added therapeutic value to stroke survivors, current TOT guidance offers insufficient advice on standardisation, particularly choices of intensity, for clinical practice. Therefore, this study aims to explore the effects of different intensities of TOT on motor function and self-care ability of stroke survivors.
This randomised controlled clinical trial will recruit 72 participants from a tertiary hospital, diagnosed with decreased self-care ability and upper limb motor dysfunction post-stroke. All participants will be randomly assigned to one of three experimental groups or the control group to undergo intervention for 8 weeks. The participants in the control group (n=18) will receive traditional occupational therapy, while those in the experimental groups will receive different intensities of TOT (50%, 75% and 100% intensity for groups A, B and C, respectively). This protocol designed a more innovative and optimised TOT programme to explore the optimal intensity of TOT on stroke survivors. The primary outcome is Canadian Occupational Performance Measure, and the secondary outcomes include Modified Barthel Index, Wolf Motor Function Test and Motor Activity Log.
The Second Affiliated Hospital of Hainan Medical University Ethics Committee approved the medical and ethical protocol for this study (LW2022015). All participants will sign an informed consent form. The results will be presented in scientific conferences and published in peer-reviewed journals.
ChiCTR2200056390.
Individuals with Parkinson’s disease (PD) often experience initial hesitation, slowness of movements, decreased balance and impaired standing ability, which can significantly impact their independence. Transcranial magnetic stimulation and transcranial direct current stimulation are two widely used and promising non-invasive brain stimulation (NIBS) modalities for treating PD. The supplementary motor area (SMA), associated with motor behaviour and processing, has received increasing attention as a potential stimulation target to alleviate PD-related symptoms. However, the data on NIBS over SMA in PD individuals are inconsistent and has not been synthesised. In this article, we will review the evidence for NIBS over SMA in PD individuals and evaluate its efficacy in improving PD function.
Randomised controlled clinical trials comparing the effects of NIBS and sham stimulation on motor function, activities of daily living and participation for people with PD will be included. A detailed computer-aided search of the literature will be performed from inception to February 2023 in the following databases: PubMed, EMBASE, Physiotherapy Evidence Database (PEDro), Web of Science (WOS) and The Chinese National Knowledge Infrastructure (CNKI). Two independent reviewers will screen articles for relevance and methodological validity. The PEDro scale will be used to evaluate the risk of bias of selected studies. Data from included studies will be extracted by two independent reviewers through a customised, preset data extraction sheet.
Ethical approval is not required for this systematic review. The study’s findings will be presented at scientific meetings and published in peer-reviewed journals.
CRD42023399945.
Fibromyalgia treatment trends vary globally; however, the trend in South Korea has not been investigated yet. This study aimed to analyse the fibromyalgia treatment trends in South Korea.
Retrospective, observational study using serial cross-sectional data.
The National Patient Samples of the Korean Health Insurance Review & Assessment Service from 2011 to 2018 were used.
A total of 31 059 patients with fibromyalgia were included in this study. The basic characteristics of the patients were stratified by sex, age and comorbidity. A patient was considered to have a condition if it was recorded as a principal diagnosis at least once in a year.
Trends in the types of medical visits and prescribed treatments were investigated and the values are presented as rates per 100 patients. The types of pharmacological treatment were presented according to the existing clinical guidelines. Additionally, combination prescription trends and associated characteristics were investigated.
Of the patients, 66.2% were female. Visits to internal medicine departments showed the most significant increase (2011: 11.34; 2018: 21.99; p
Our findings provide basic reference data for the development and application of national guidelines for fibromyalgia.
To compare the efficacy of a traditional cock-up splint, which supports the wrist only, with a modified splint that supports the wrist and the metacarpophalangeal (MCP) joints of the medial four digits in the treatment of carpal tunnel syndrome (CTS).
An assessor-blind randomised controlled trial.
Hospital-based hand therapy clinics.
Fifty-nine adults with mild-to-moderate CTS were randomly assigned to wear a wrist splint (control group) or an MCP splint (intervention group) for 6 weeks.
The standardised outcome measures used included grip and pinch strength, the static two-point discrimination test, Phalen’s manoeuvre test, Tinel’s sign and the Boston CTS Questionnaire.
Both groups improved significantly from splint use in some clinical features. The wrist splint and the MCP splint groups had significant improvements in lateral pinch strength (p=0.032 and p=0.002, respectively), two-point discrimination of the thumb (p=0.003 and p=0.041, respectively), two-point discrimination of the index (p=0.035 and p=0.023, respectively) and the Phalen’s manoeuvre symptoms (p=0.025 and p=0.002, respectively). The MCP splint group had additional improvements over the wrist splint group in tip pinch (p=0.012) and Palmar pinch (p=0.011) strength.
Splinting is a practical and effective intervention option for improving the symptoms of CTS. A wrist splint that incorporates the MCP joints is more effective than the traditional wrist-only splint, with long-lasting improvements that remained consistent after 6 months of the splint intervention. Using the more effective MCP splint may consequently reduce disability, facilitate return to work and lower the associated costs.
Millions of people survive injuries to the central or peripheral nervous system for which neurorehabilitation is required. In addition to the physical and cognitive impairments, many neurorehabilitation patients experience pain, often not widely recognised and inadequately treated. This is particularly true for multiple sclerosis (MS) patients, for whom pain is one of the most common symptoms. In clinical practice, pain assessment is usually conducted based on a subjective estimate. This approach can lead to inaccurate evaluations due to the influence of numerous factors, including emotional or cognitive aspects. To date, no objective and simple to use clinical methods allow objective quantification of pain and the diagnostic differentiation between the two main types of pain (nociceptive vs neuropathic). Wearable technologies and artificial intelligence (AI) have the potential to bridge this gap by continuously monitoring patients’ health parameters and extracting meaningful information from them. Therefore, we propose to develop a new automatic AI-powered tool to assess pain and its characteristics during neurorehabilitation treatments using physiological signals collected by wearable sensors.
We aim to recruit 15 participants suffering from MS undergoing physiotherapy treatment. During the study, participants will wear a wristband for three consecutive days and be monitored before and after their physiotherapy sessions. Measurement of traditionally used pain assessment questionnaires and scales (ie, painDETECT, Doleur Neuropathique 4 Questions, EuroQoL-5-dimension-3-level) and physiological signals (photoplethysmography, electrodermal activity, skin temperature, accelerometer data) will be collected. Relevant parameters from physiological signals will be identified, and AI algorithms will be used to develop automatic classification methods.
The study has been approved by the local Ethical Committee (285-2022-SPER-AUSLBO). Participants are required to provide written informed consent. The results will be disseminated through contributions to international conferences and scientific journals, and they will also be included in a doctoral dissertation.
Stroke is a significant worldwide cause of death and a prevalent contributor to long-term disability among adults. Survivors commonly encounter a wide array of motor, sensory and cognitive impairments. Rehabilitation interventions, mainly targeting the upper extremities, include a wide array of components, although the evidence indicates that the intensity of practice and task-specific training play crucial roles in facilitating effective results. Assisted therapy with electronic devices designed for the affected upper extremity could be employed to enable partial or total control of this limb, while simultaneously incorporating the aforementioned characteristics in the rehabilitation process.
32 adults who had a subacute or chronic stroke, aged over 18 years old, will be included for this randomised controlled trial aiming to determine the non-inferiority effect of the inclusion of a robotic device (ALBA) to regular treatment against only regular rehabilitation. Participants will be assessed before and after 4 weeks of intervention and at 3 months of follow-up. The primary outcome will be the Fugl-Meyer assessment for upper extremities; secondary outcomes will include the questionnaires Functional Independence Measure, Medical Outcomes Study 36-item Short-Form Health Survey as well as the System Usability Scale.
Full ethical approval was obtained for this study from the scientific and ethical review board Servicio de Salud Metropolitano Oriente of Santiago (approval number: SSMOriente030522), and the recommendations of the Chilean law no 20120 of 7 September 2006, concerning scientific research in the human being, its genome and human cloning, will be followed. Ahead of inclusion, potential participants will read and sign a written informed consent form. Future findings will be presented and published in conferences and peer-reviewed journals.
International ClinicalTrials.gov Registry (NCT05824416;
The objective of this study was to determine the feasibility and effectiveness of using SUpported Motivational InTerviewing (SUMIT) to increase physical activity in people with knee osteoarthritis (KOA).
Randomised controlled trial.
We recruited people who had completed Good Life with osteoArthritis Denmark (GLA:D) from private, public and community settings in Victoria, Australia.
Participants were randomised participants to receive SUMIT or usual care. SUMIT comprised five motivational interviewing sessions targeting physical activity over 10 weeks, and access to a multimedia web-based platform.
Thirty-two participants were recruited (17 SUMIT, 15 control) including 22 females (69%).
Feasibility outcomes included recruitment rate, adherence to motivational interviewing, ActivPAL wear and drop-out rate. Effect sizes (ESs) were calculated for daily steps, stepping time, time with cadence >100 steps per minute, time in bouts >1 min; 6 min walk distance, Knee Osteoarthritis Outcome Score (KOOS) subscales (pain, symptoms, function, sport and recreation, and quality of life (QoL)), Euroqual, systolic blood pressure, body mass index, waist circumference, 30 s chair stand test and walking speed during 40 m walk test.
All feasibility criteria were achieved, with 32/63 eligible participants recruited over seven months; with all participants adhering to all motivational interviewing calls and achieving sufficient ActivPAL wear time, and only two drop-outs (6%).
12/15 outcome measures showed at least a small effect (ES>0.2) favouring the SUMIT group, including daily time with cadence >100 steps per minute (ES=0.43). Two outcomes, walking speed (ES= 0.97) and KOOS QoL (ES=0.81), showed a large effect (ES>0.8).
SUMIT is feasible in people with knee osteoarthritis. Potential benefits included more time spent walking at moderate intensity, faster walking speeds and better QoL.
ACTRN12621000267853.