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StrokeNCT05090163

Prep Plus: Upper Limb Stroke Rehabilitation in the Community

A study testing PREP Plus and PREP in people with Stroke, run by University of Ulster at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
PREP Plus and PREP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited Kingdom
Study dates
19 Jan 2022to 1 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Ulster University

    Jordanstown, Northern Ireland, BT37 0QB

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
Stroke
Being tested
PREP Plus, PREP
Keywords
Upper limb, Physical activity, Rehabilitation
Medical subject headings
Stroke, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PREP PlusOther

    Group based exercise in addition to PREP exercises

  • PREPOther

    Group based exercise

Study groups in NCT05090163
Study groupRoleWhat they receive
PREP groupActive comparatorControl group
Receives: Other: PREP
PREP Plus groupExperimentalIntervention group
Receives: Other: PREP Plus

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 weeks

Secondary outcomes (3)

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

    Mental wellbeing and quality of life measure

    Measured: 6 weeks

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

    functional performance measure

    Measured: 6 weeks

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

    lower limb functional performance test

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2021
  2. Study start19 Jan 2022
  3. Primary completion28 Feb 2023
  4. Study completion1 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05090163
Sponsor's protocol ID
21/NI/0043
Status last verified
Feb 2024
First submitted
22 Sep 2021
Last updated
1 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Any published data from the study will be available on the Ulster University data repository

Publications

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

    PubMed 21571152

  • 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.

    PubMed 24505342

  • 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.

    PubMed 25533758

  • 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.

    PubMed 23227818

  • 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.

    PubMed 23896334

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

    PubMed 17039223

  • 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.

    PubMed 16401430

  • 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.

    PubMed 21693771

  • 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.

    PubMed 29025365

  • 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.

    PubMed 39414298

  • 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.

    PubMed 36669847

Questions about this trial

What is this clinical trial studying?

A study testing PREP Plus and PREP in people with Stroke, run by University of Ulster at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05090163, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.

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Clinical Trial NCT05090163 | AzTrials