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| Name | Class |
|---|---|
| Northern Ireland Chest Heart and Stroke | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREP group | Active Comparator | Control group |
|
| PREP Plus group | Experimental | Intervention group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREP Plus | Other | Group based exercise in addition to PREP exercises |
| |
| 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 | upper limb use | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Edinburgh Warwick Questionnaire: Measuring change in mental wellbeing from baseline to 6 weeks | Mental wellbeing and quality of life measure | 6 weeks |
| 10 meter walk test: Measuring change in walking speed from baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Focus group with participants | Overall experience: Stroke survivor experience | end of 6 weeks |
| 1:1 interviews with intervention therapist | Determine optimum design considering acceptability, practicality and resources. Therapist experience and practicality of delivery |
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
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| Name | Affiliation | Role |
|---|---|---|
| Katy Pedlow | Ulster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulster University | Jordanstown | Northern Ireland | BT37 0QB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21571152 | Background | Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5. | |
| 24505342 | Background | 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. |
| Label | URL |
|---|---|
| Global Health Estimates | View source |
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Any published data from the study will be available on the Ulster University data repository
September 2023
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| PREP |
| Other |
Group based exercise |
|
functional performance measure
| 6 weeks |
| Timed Get up and Go [TUG] test: Measuring change in lower limb function from baseline to 6 weeks | lower limb functional performance test | 6 weeks |
| end of 6 weeks |
| Caregivers questionnaire provided at post intervention. | Overall experience: View accessibility of the group from a carer point of view | end of 6 weeks |
| Recruitment log | 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 | Retention rates: Percentage of participants who completed the 6 week programme | Throughout the study completion, an average of 1 year |
| 25533758 | Background | 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. |
| 23227818 | Background | 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. |
| 23896334 | Background | 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. |
| 17039223 | Background | Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56. |
| 16401430 | Background | 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. |
| 21693771 | Background | 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. |
| 29025365 | Background | 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. |
| 39414298 | Derived | 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. |
| 36669847 | Derived | 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. |
| Stroke Guidelines | View source |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |