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Completed

NCT Number: NCT05090163

Prep Plus: Upper Limb Stroke Rehabilitation in the Community

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ulster University

Jordanstown, Northern Ireland, BT37 0QB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PREP Plus

Other

Group based exercise in addition to PREP exercises

PREP

Other

Group based exercise

Primary outcomes

  1. Rating of Everyday Arm-use in the Community and Home (REACH) Scale: Measuring change in upper limb use from baseline to 6 weeks

    Time frame: 6 weeks

    upper limb use

Secondary outcomes

  1. Edinburgh Warwick Questionnaire: Measuring change in mental wellbeing from baseline to 6 weeks

    Time frame: 6 weeks

    Mental wellbeing and quality of life measure

  2. 10 meter walk test: Measuring change in walking speed from baseline to 6 weeks

    Time frame: 6 weeks

    functional performance measure

  3. Timed Get up and Go [TUG] test: Measuring change in lower limb function from baseline to 6 weeks

    Time frame: 6 weeks

    lower limb functional performance test

Other outcomes

  1. Focus group with participants

    Time frame: end of 6 weeks

    Overall experience: Stroke survivor experience

  2. 1:1 interviews with intervention therapist

    Time frame: end of 6 weeks

    Determine optimum design considering acceptability, practicality and resources. Therapist experience and practicality of delivery

  3. Caregivers questionnaire provided at post intervention.

    Time frame: end of 6 weeks

    Overall experience: View accessibility of the group from a carer point of view

  4. Recruitment log

    Time frame: 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

  5. Weekly attendance records

    Time frame: Throughout the study completion, an average of 1 year

    Retention rates: Percentage of participants who completed the 6 week programme

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Northern Ireland Chest Heart and Stroke

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2021
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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