Prep Plus: Upper Limb Stroke Rehabilitation in the Community

Study Overview
=================
Brief Summary
-----------------
PREP Plus aims to create support for those who have survived stroke(s) and are still experiencing weakness in the upper limbs. In conjunction with the PREP programme, and based on the GRASP programme, the aim is to evaluate the feasibility, acceptability, and efficacy of an upper limb intervention support for survivors. Integration of an evidence based upper limb programme to an established physical activity programme will be a feasible method to support long term upper limb rehabilitation to community dwelling stroke survivors.

Detailed Description
-----------------
The main objectives for overall study is to assess acceptability of the demand of the trial as well as the PREP Plus intervention placed on survivors and their carers. Within this mixed methods study, the investigators aim to recruit participants in a total of three waves. Each site will deliver 6 weeks of the intervention / control with a new set of participants before post intervention qualitative measures (focus groups and 1:1 interviews) are used to inform the design of the next wave. With having the trial in three waves, their objective is to optimise the design of upper limb rehab and the delivery by therapists with preparing them with adequate training and resources aimed toward upper limb rehab in survivors of stroke. Participant recruitment will integrate into the current PREP programme design. All participants will complete one hour of circuit-based exercises followed by one hour of education. The exercise stations will focus on lower body/cardiovascular fitness station and upper limb strength exercises. Each week the amount of time spent at each station will be increased by 30 seconds resulting in a final 3 minutes at each station. Those in the intervention group, will have an additional five exercises that focus on upper limb stretching, arm stretching, hand stretching, coordination, and hand skills.

Official Title
-----------------
Prep Plus: Supporting Upper Limb Practice in Community Dwelling Stroke Survivors

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: PREP Plus
* Other: PREP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of stroke Have completed statutory rehabilitation Able to follow two part written or spoken commands Are medically fit to complete exercise, as determined by their GP Having an impairment of their upper limb, as identified by the participant and/ or their community stroke team. Exclusion Criteria: Pain score of 5/more in their impaired upper limb. Not participating in any other trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each site will deliver 6 weeks of the intervention / control with a new set of participants before post intervention qualitative measures are used to inform the design of the next wave.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PREP group<br>Control group | Other: PREP<br>* Group based exercise<br>|
| Experimental: PREP Plus group<br>Intervention group | Other: PREP Plus<br>* Group based exercise in addition to PREP exercises<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 meter walk test: Measuring change in walking speed from baseline to 6 weeks | functional performance measure | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Warwick Questionnaire: Measuring change in mental wellbeing from baseline to 6 weeks | Mental wellbeing and quality of life measure | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical activity, Rehabilitation, Upper limb