Parkinson’s disease (PD) is the second most common neurodegenerative disorder, its principal symptom being deterioration of motor function. Current treatment options are limited to symptom management but there is evidence that physical activity can provide motor benefits. More recently there is evidence to suggest that rhythmic auditory stimulation may improve gait and balance in PD. Sparky Samba is a community initiative in South Wales, UK, founded by a person living with PD. Sessions incorporate the following samba rhythms from a trained facilitator and are held weekly in a community setting.
The Sparky Samba trial is a multi-site, non-blinded, randomised controlled feasibility trial of Sparky Samba compared with activity as usual. A total of 60 people with PD will be randomised 1:1 to take part in a local Sparky Samba group for 12 weeks or continue their normal activities for the same length of time. The primary outcome is feasibility defined by recruitment, retention, data completeness and intervention adherence. Secondary outcomes relating to motor function, cognition, well-being and self-efficacy will also be assessed at baseline and at 12 weeks. Additionally, we will conduct a process evaluation to understand contextual mechanisms surrounding Sparky Samba. This will be achieved through qualitative interviews and structured participant questionnaires following individual trial completion and through structured questionnaires with intervention delivery staff, supplemented with qualitative interviews.
Feasibility outcomes will be assessed according to pre-defined criteria. For secondary outcomes, means and standard deviations (or medians and IQRs) will be calculated by arm, alongside 95% CIs for change from baseline to 12-week follow-up. Qualitative data will be subject to thematic analysis using NVivo software.
This study received a favourable ethical opinion from the North of Scotland Research Ethics Committee in April 2025 (REC reference 25/NS/0037). Study results will be disseminated through the peer-review literature, the ISRCTN registry and directly to participants, which will be facilitated by the study’s public and patient involvement steering group.
Improved survival from critical illness has led to an increase in patients with long-term physical and psychological morbidity. Postintensive care rehabilitation services are variable and it is recognised that there is a need for inclusive and accessible interventions to support recovery after critical illness. We engaged with people with lived experience of critical care admission to co-produce a virtual reality mediated intervention (ViRtual REality to AiD recoverY post intensive care unit (ICU) (VR READY).
Our primary objective was to determine the feasibility and acceptability of VR READY to improve the patient experience during recovery from critical illness. Secondary objectives included assessment of the feasibility and acceptability of selected outcome measures for use in future efficacy and cost-effectiveness studies for ICU recovery.
The co-developed intervention (VR READY) was evaluated in a single arm, non-randomised feasibility trial with embedded process evaluation in patients leaving critical care.
District General Hospital in Wales.
Adults who had been admitted to an ICU requiring organ support for more than 48 hours during their current hospital admission. Patients were approached at the point of stepping down from the ICU to a general ward (±48 hours). 87 patients were screened for eligibility, 37 were approached and 22 participants were recruited.
Participants were asked to use VR READY for at least 5 min per day for 14 days.
The primary outcome was feasibility defined by prespecified criteria. Secondary outcomes prioritised by patients and pertaining to recovery and well-being were assessed at baseline and 14 days. A qualitative interview was conducted 4–6 weeks later.
22 participants were recruited with 91% completion of baseline measures, 49.5% completion at 14-day follow-up and 27.3% completing the qualitative interview. Intervention adherence was poor (37.9%), however qualitative findings suggested that participants that engaged with the intervention considered VR READY beneficial to their recovery. While feasibility criteria were met for recruitment and data completion, criteria for retention and intervention adherence were not.
Critical illness is a traumatic experience. Our co-developed rehabilitation intervention VR READY was not feasible in its current format, potentially as a result of being offered too early in recovery when patients were struggling with fatigue, motivation and resilience. VR READY may be beneficial to recovery but further research is needed into optimal mode and timing.