Prep Plus: Upper Limb Stroke Rehabilitation in the Community

NCT ID: NCT05090163

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-19

Study Completion Date

2023-04-01

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PREP group

Control group

Group Type ACTIVE_COMPARATOR

PREP

Intervention Type OTHER

Group based exercise

PREP Plus group

Intervention group

Group Type EXPERIMENTAL

PREP Plus

Intervention Type OTHER

Group based exercise in addition to PREP exercises

Interventions

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PREP Plus

Group based exercise in addition to PREP exercises

Intervention Type OTHER

PREP

Group based exercise

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Ireland Chest Heart and Stroke

OTHER

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role lead

Responsible Party

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Katy Pedlow

Dr Katy Pedlow, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katy Pedlow

Role: PRINCIPAL_INVESTIGATOR

Ulster University

Locations

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Ulster University

Jordanstown, Northern Ireland, United Kingdom

Site Status

Countries

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United Kingdom

References

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Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

Reference Type BACKGROUND
PMID: 21571152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24505342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25533758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23227818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23896334 (View on PubMed)

Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56.

Reference Type BACKGROUND
PMID: 17039223 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16401430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21693771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29025365 (View on PubMed)

Pedlow K, Kennedy NC, Klempel N, Eng JJ, Adamson G, Hylands J, Hughes N, Campbell Z, McDonough S. Post-rehabilitation programme to support upper limb recovery in community-dwelling stroke survivors: a mixed methods cluster-feasibility controlled trial. BMJ Open. 2024 Oct 15;14(10):e088301. doi: 10.1136/bmjopen-2024-088301.

Reference Type DERIVED
PMID: 39414298 (View on PubMed)

Pedlow K, McDonough S, Klempel N, Hylands J, Hughes N, Campbell Z, Eng JJ, Stephenson A, Kennedy N. PREP Plus combined postrehabilitation programme to support upper limb recovery in community-dwelling stroke survivors: protocol for a mixed-methods, cluster-assigned feasibility study. BMJ Open. 2023 Jan 20;13(1):e069016. doi: 10.1136/bmjopen-2022-069016.

Reference Type DERIVED
PMID: 36669847 (View on PubMed)

Related Links

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Other Identifiers

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21/NI/0043

Identifier Type: -

Identifier Source: org_study_id

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