Prep Plus: Upper Limb Stroke Rehabilitation in the Community

Stroke Clinical Trial

Official title:

Prep Plus: Supporting Upper Limb Practice in Community Dwelling Stroke Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05090163
• Other study ID #: 21/NI/0043
• Status: Completed
• Phase: N/A
• Start date: January 19, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2024
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 1, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• PREP Plus
Group based exercise in addition to PREP exercises
• PREP
Group based exercise

Locations

Country	Name	City	State
United Kingdom	Ulster University	Jordanstown	Northern Ireland

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	Northern Ireland Chest Heart and Stroke

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Focus group with participants	Overall experience: Stroke survivor experience	end of 6 weeks
Other	1:1 interviews with intervention therapist	Determine optimum design considering acceptability, practicality and resources. Therapist experience and practicality of delivery	end of 6 weeks
Other	Caregivers questionnaire provided at post intervention.	Overall experience: View accessibility of the group from a carer point of view	end of 6 weeks
Other	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
Other	Weekly attendance records	Retention rates: Percentage of participants who completed the 6 week programme	Throughout the study completion, an average of 1 year
Primary	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	Edinburgh Warwick Questionnaire: Measuring change in mental wellbeing from baseline to 6 weeks	Mental wellbeing and quality of life measure	6 weeks
Secondary	10 meter walk test: Measuring change in walking speed from baseline to 6 weeks	functional performance measure	6 weeks
Secondary	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

External Links

•   Global Health Estimates
•   Stroke Association
•   Stroke Guidelines