Prep Plus: Upper Limb Stroke Rehabilitation in the Community
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PREP Plus
PREP
Sponsored by

About this trial
This is an interventional supportive care trial for Stroke focused on measuring Upper limb, Physical activity, Rehabilitation
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
Sites / Locations
- Ulster University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
PREP group
PREP Plus group
Arm Description
Control group
Intervention group
Outcomes
Primary Outcome Measures
10 meter walk test: Measuring change in walking speed from baseline to 6 weeks
functional performance measure
Secondary Outcome Measures
Edinburgh Warwick Questionnaire: Measuring change in mental wellbeing from baseline to 6 weeks
Mental wellbeing and quality of life measure
Full Information
NCT ID
NCT05090163
First Posted
September 22, 2021
Last Updated
May 10, 2023
Sponsor
University of Ulster
Collaborators
Northern Ireland Chest Heart and Stroke
1. Study Identification
Unique Protocol Identification Number
NCT05090163
Brief Title
Prep Plus: Upper Limb Stroke Rehabilitation in the Community
Official Title
Prep Plus: Supporting Upper Limb Practice in Community Dwelling Stroke Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulster
Collaborators
Northern Ireland Chest Heart and Stroke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Upper limb, Physical activity, Rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PREP group
Arm Type
Active Comparator
Arm Description
Control group
Arm Title
PREP Plus group
Arm Type
Experimental
Arm Description
Intervention group
Intervention Type
Other
Intervention Name(s)
PREP Plus
Intervention Description
Group based exercise in addition to PREP exercises
Intervention Type
Other
Intervention Name(s)
PREP
Intervention Description
Group based exercise
Primary Outcome Measure Information:
Title
10 meter walk test: Measuring change in walking speed from baseline to 6 weeks
Description
functional performance measure
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Edinburgh Warwick Questionnaire: Measuring change in mental wellbeing from baseline to 6 weeks
Description
Mental wellbeing and quality of life measure
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Timed Get up and Go [TUG] test: Measuring change in lower limb function from baseline to 6 weeks
Description
lower limb functional performance test
Time Frame
6 weeks
Title
Rating of Everyday Arm-use in the Community and Home (REACH) Scale: Measuring change in upper limb use from baseline to 6 weeks
Description
upper limb use
Time Frame
6 weeks
Title
Focus group with participants
Description
Overall experience: Stroke survivor experience
Time Frame
end of 6 weeks
Title
1:1 interviews with intervention therapist
Description
Determine optimum design considering acceptability, practicality and resources. Therapist experience and practicality of delivery
Time Frame
end of 6 weeks
Title
Caregivers questionnaire provided at post intervention.
Description
Overall experience: View accessibility of the group from a carer point of view
Time Frame
end of 6 weeks
Title
Recruitment log
Description
Recruitment rate: Percentage of eligible participants approached and agreed to participate Refusal reason: Participant reason for refusal linked to (A) Study process, (B) Intervention
Time Frame
Throughout the study completion, an average of 1 year
Title
Weekly attendance records
Description
Retention rates: Percentage of participants who completed the 6 week programme
Time Frame
Throughout the study completion, an average of 1 year
Title
Fidelity: Apriori checklists
Description
Determine delivery of content and session duration
Time Frame
Throughout the 6 weeks, total of 30 weeks
Title
Intervention delivery costs
Description
Additional staff time record
Transaction list of equipment
Consumables Impact for future service delivery
Time Frame
Throughout the study completion, an average of 1 year
Title
Motor Activity Log: Use of upper limb in everyday life
Description
Percentage of change in overall score (Amount of movement and quality of movement)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katy Pedlow
Organizational Affiliation
Ulster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulster University
City
Jordanstown
State/Province
Northern Ireland
ZIP/Postal Code
BT37 0QB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://pure.ulster.ac.uk/en/persons/katy-pedlow
Citations:
PubMed Identifier
21571152
Citation
Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
Results Reference
background
PubMed Identifier
24505342
Citation
Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
Results Reference
background
PubMed Identifier
25533758
Citation
Rand D, Eng JJ. Predicting daily use of the affected upper extremity 1 year after stroke. J Stroke Cerebrovasc Dis. 2015 Feb;24(2):274-83. doi: 10.1016/j.jstrokecerebrovasdis.2014.07.039. Epub 2014 Dec 18.
Results Reference
background
PubMed Identifier
23227818
Citation
Pollock A, St George B, Fenton M, Firkins L. Top 10 research priorities relating to life after stroke--consensus from stroke survivors, caregivers, and health professionals. Int J Stroke. 2014 Apr;9(3):313-20. doi: 10.1111/j.1747-4949.2012.00942.x. Epub 2012 Dec 11.
Results Reference
background
PubMed Identifier
23896334
Citation
Kwah LK, Harvey LA, Diong J, Herbert RD. Models containing age and NIHSS predict recovery of ambulation and upper limb function six months after stroke: an observational study. J Physiother. 2013 Sep;59(3):189-97. doi: 10.1016/S1836-9553(13)70183-8. Erratum In: J Physiother. 2013 Dec;59(4):218.
Results Reference
background
PubMed Identifier
17039223
Citation
Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56.
Results Reference
background
PubMed Identifier
16401430
Citation
Pang MY, Harris JE, Eng JJ. A community-based upper-extremity group exercise program improves motor function and performance of functional activities in chronic stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2006 Jan;87(1):1-9. doi: 10.1016/j.apmr.2005.08.113.
Results Reference
background
PubMed Identifier
21693771
Citation
Rand D, Eng JJ. Disparity between functional recovery and daily use of the upper and lower extremities during subacute stroke rehabilitation. Neurorehabil Neural Repair. 2012 Jan;26(1):76-84. doi: 10.1177/1545968311408918. Epub 2011 Jun 21.
Results Reference
background
PubMed Identifier
29025365
Citation
Arwert H, Schut S, Boiten J, Vliet Vlieland T, Meesters J. Patient reported outcomes of hand function three years after stroke. Top Stroke Rehabil. 2018 Jan;25(1):13-19. doi: 10.1080/10749357.2017.1385232. Epub 2017 Oct 12.
Results Reference
background
Links:
URL
https://www.stroke.org.uk/sites/default/files/stroke_association_ni_struggling_to_recover_report_18.2.2019.pdf
Description
Stroke Association
URL
https://www.who.int/data/global-health-estimates
Description
Global Health Estimates
URL
https://www.rcplondon.ac.uk/guidelines-policy/stroke-guidelines
Description
Stroke Guidelines
Learn more about this trial
Prep Plus: Upper Limb Stroke Rehabilitation in the Community
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