Stroke
Conditions
Keywords
Upper limb, Physical activity, Rehabilitation
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.
Interventions
OTHERPREP Plus
Group based exercise in addition to PREP exercises
OTHERPREP
Group based exercise
Sponsors
Northern Ireland Chest Heart and Stroke
University of Ulster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rating of Everyday Arm-use in the Community and Home (REACH) Scale: Measuring change in upper limb use from baseline to 6 weeks | 6 weeks | upper limb use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh Warwick Questionnaire: Measuring change in mental wellbeing from baseline to 6 weeks | 6 weeks | Mental wellbeing and quality of life measure |
| 10 meter walk test: Measuring change in walking speed from baseline to 6 weeks | 6 weeks | functional performance measure |
| Timed Get up and Go [TUG] test: Measuring change in lower limb function from baseline to 6 weeks | 6 weeks | lower limb functional performance test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Focus group with participants | end of 6 weeks | Overall experience: Stroke survivor experience |
| Weekly attendance records | Throughout the study completion, an average of 1 year | Retention rates: Percentage of participants who completed the 6 week programme |
| 1:1 interviews with intervention therapist | end of 6 weeks | Determine optimum design considering acceptability, practicality and resources. Therapist experience and practicality of delivery |
| Caregivers questionnaire provided at post intervention. | end of 6 weeks | Overall experience: View accessibility of the group from a carer point of view |
| Recruitment log | Throughout the study completion, an average of 1 year | Recruitment rate: Percentage of eligible participants approached and agreed to participate Refusal reason: Participant reason for refusal linked to (A) Study process, (B) Intervention |
Countries
United Kingdom
Outcome results
None listed