NCT05090163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 19, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

September 22, 2021

Last Update Submit

February 28, 2024

Conditions

Stroke

Keywords

Upper limbPhysical activityRehabilitation

Outcome Measures

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

    upper limb use

    6 weeks

Secondary Outcomes (3)

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

    6 weeks

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

    6 weeks

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

    6 weeks

Other Outcomes (5)

  • Focus group with participants

    end of 6 weeks

  • 1:1 interviews with intervention therapist

    end of 6 weeks

  • Caregivers questionnaire provided at post intervention.

    end of 6 weeks

  • +2 more other outcomes

Study Arms (2)

PREP group

ACTIVE COMPARATOR

Control group

Other: PREP

PREP Plus group

EXPERIMENTAL

Intervention group

Other: PREP Plus

Interventions

PREP PlusOTHER

Group based exercise in addition to PREP exercises

PREP Plus group
PREPOTHER

Group based exercise

PREP group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pain score of 5/more in their impaired upper limb. Not participating in any other trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulster University

Jordanstown, Northern Ireland, BT37 0QB, United Kingdom

Location

Related Publications (11)

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

    PMID: 21571152BACKGROUND

  • 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.

    PMID: 24505342BACKGROUND

  • 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.

    PMID: 25533758BACKGROUND

  • 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.

    PMID: 23227818BACKGROUND

  • 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.

    PMID: 23896334BACKGROUND

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

    PMID: 17039223BACKGROUND

  • 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.

    PMID: 16401430BACKGROUND

  • 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.

    PMID: 21693771BACKGROUND

  • 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.

    PMID: 29025365BACKGROUND

  • 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.

    PMID: 39414298DERIVED

  • 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.

    PMID: 36669847DERIVED

Related Links

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Katy Pedlow

    Ulster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Katy Pedlow, Principal Investigator

Study Record Dates

First Submitted

September 22, 2021

First Posted

October 22, 2021

Study Start

January 19, 2022

Primary Completion

February 28, 2023

Study Completion

April 1, 2023

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
September 2023
More information

Locations

GB(1)