Prep Plus: Upper Limb Stroke Rehabilitation in the Community

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: PREP; Other: PREP Plus

• Registration Number: NCT05090163
• Lead Sponsor: University of Ulster

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.

Study Timeline

• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-22
• Study Start: 2022-01-19
• Primary Completion: 2023-02-28
• Study Completion: 2023-04-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PREP group	PREP	Control group
PREP Plus group	PREP Plus	Intervention group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Edinburgh Warwick Questionnaire: Measuring change in mental wellbeing from baseline to 6 weeks	6 weeks	Mental wellbeing and quality of life measure

Trial Locations

Locations (1)

Ulster University; 🇬🇧 Jordanstown, Northern Ireland, United Kingdom