Upper Limb Stroke Rehabilitation Via the VirtualRehab Platform
- Conditions
- Stroke
- Interventions
- Other: Exercise-based games via the VirtualRehab platform
- Registration Number
- NCT04517812
- Lead Sponsor
- University of East Anglia
- Brief Summary
This study will deliver a 12-week exercise-based upper limb virtual reality, non-immersive, rehabilitation programme for stroke survivors. The aims are to:1. to assess the acceptability and usability of the VirtualRehab platform for delivery of stroke rehabilitation at home:
2. to find if stroke survivors adhere to 'prescribed' use of the VirtualRehab platform over a 12-week period; 3. to assess the viability of using randomised length of baselines and repeated measures during the intervention period to inform subsequent study to find the optimum therapeutic dose 4. to estimate how a 12-week period of using the VirtualRehab platform could change motor impairment and functional capacity.
- Detailed Description
Background and objectives:
This study is driven by the hypothesis that provision of task-orientated training via a non-immersive virtual reality platform enhances upper limb motor and neural function more than current routine physical therapy for people with stroke. Before this hypothesis can be tested in a randomised controlled clinical trial. If evidence of concept is found, then the next step is identification of the optimum therapeutic dose of exercised-based therapy delivered via the Virtualrehab Platform as a precursor to a clinical efficacy trial. The specific objectives of the study reported here were:
1. to assess the acceptability and usability of the VirtualRehab platform for delivery of stroke rehabilitation at home:
2. to find if stroke survivors adhere to 'prescribed' use of the VirtualRehab platform over a 12-week period;
3. to assess the viability of using randomised length of baselines and repeated measures during the intervention period to inform subsequent study to find the optimum therapeutic dose
4. to estimate how a 12-week period of
Design:
A series of replicated single case studies with an AB design (2.1). During the A, control, phase participants will not receive the experimental intervention. Participants will receive the experimental intervention during the B phase. At the beginning of the control phase, participants will complete the measurement battery. These will be the baseline-one measures. The measurement battery will be repeated at the end of the baseline phase (baseline-two) and at the end of the intervention phase (outcome). Progress measures will be made at the end of every week of the intervention (B) phase.
Both sets of baselines and the outcome measures will be taken in the Movement and Exercise Laboratory (MovExLab) at the University of East Anglia (UEA). Progress measures will be made in participants' homes. The control phase will last for a randomised period of between one and four weeks. The time period for the control phase will be decided for each participant by a randomised sequence generated before the study begins, by a researcher independent of the research team for this study. The intervention phase will last for 12 weeks. During the intervention phase, each participant will undertake weekly progress measures in their home. These will be administered by the researchers prescribing and monitoring training. At the end of the control and the intervention phase, all participants will participate in a 1:1 semi-structured interview with the researcher.
A group of adults without any reported neurological damage undertook the measurement battery to provide reference values. The measurement battery and progress measures are described below.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention group Exercise-based games via the VirtualRehab platform The intervention group will carry out a 12-week exercise-based intervention delivered via the VirtualRehab platform. The exercise-games have been designed from conventional physiotherapy exercises for stroke rehabilitation. A personalised training programme will be created for individual participants by a qualified physiotherapist member of the research team. Each participant will be asked to undertake their set exercise-based training programme for one hour a day, six days a week for 12 weeks.
- Primary Outcome Measures
Name Time Method Surface Electromyography, change over intervention period baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks) Time to onset for muscle activity during a reaching task
Change in motor impairment, over intervention period baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks) The Motricity Index (scores)
Change in functional ability, pre to post baseline 1, baseline 2, post-intervention (3 weeks) The Wolf Motor Function Test (WMFT) scores
Change in motor impairment, pre to post baseline 1, baseline 2, post-intervention (3 weeks) Hand grip force forces (KG) will be made using a Myometer.
Change in functional ability, over intervention period baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks) iThe Action Reaction Arm Test (ARAT).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The University of East Anglia Movement and Exercise Physiology Lab
🇬🇧Norwich, Norfolk, United Kingdom