Prep Plus: Upper Limb Stroke Rehabilitation in the Community

February 28, 2024 updated by: Katy Pedlow, University of Ulster

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Northern Ireland
      • Jordanstown, Northern Ireland, United Kingdom, BT37 0QB
        • Ulster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PREP group
Control group
Other: PREP
Group based exercise
Experimental: PREP Plus group
Intervention group
Other: PREP Plus
Group based exercise in addition to PREP exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 meter walk test: Measuring change in walking speed from baseline to 6 weeks
Time Frame: 6 weeks
functional performance measure
6 weeks
Edinburgh Warwick Questionnaire: Measuring change in mental wellbeing from baseline to 6 weeks
Time Frame: 6 weeks
Mental wellbeing and quality of life measure
6 weeks
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
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Focus group with participants
Time Frame: end of 6 weeks
Overall experience: Stroke survivor experience
end of 6 weeks
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
end of 6 weeks
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
end of 6 weeks
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
Throughout the study completion, an average of 1 year
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
Throughout the study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulster

Collaborators

Northern Ireland Chest Heart and Stroke

Investigators

  • Principal Investigator: Katy Pedlow, Ulster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

October 11, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/NI/0043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Any published data from the study will be available on the Ulster University data repository

IPD Sharing Time Frame

September 2023

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on PREP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe