Self-directed Adapted Gaming Exercises for Stroke Survivors — SAGE  

Stroke Clinical Trial

Official title: A Multicentre Pilot Randomised Control Trial of an Adapted Mobile Rehabilitation System for Self-directed Rehabilitation and Improved Upper Limb Outcomes in Stroke Survivors With Upper Limb Weakness

Status Completed

Clinical Trial Summary

A pilot multicentre randomised control trial (RCT), examining upper limb (UL) outcomes amongst stroke survivors implementing a technology-based, self-directed UL intervention as an adjunct to conventional care.

Clinical Trial Description

Title: A multicentre pilot randomised control trial (RCT) of an adapted mobile rehabilitation system (GripAble) for self-directed upper limb (UL) rehabilitation and improved UL outcomes in stroke survivors with UL weakness.

Design: Interventional (clinical trial). A multicentre pilot RCT, parallel design, comparing intervention group (self-selected dose of self-directed technology-based UL exercise as an adjunct to conventional care) with a control group receiving conventional care only. A mixed methods research design will be implemented. This will be an assessor-blinded protocol, due to the nature of the intervention, participants cannot be blinded. This will be an internal pilot, if no changes are made to the protocol and additional funding is secured, the data from this pilot work will be used be used as part of an adequately powered RCT.

Aims: To test research design considerations in preparation for a definitive multicentre RCT. To explore the hypothesis that stroke survivors with UL weakness will engage in self-directed exercise (without direct professional supervision) as an adjunct to conventional care and demonstrate significant improvement in UL outcomes when provided with an adapted mobile rehabilitation system, compared with a control group participating in conventional care only.

Outcome Measures: The primary end point outcome will be based on intention to treat analysis on the Fugl Meyer Upper Extremity Assessment (FM-UE) at 6months post randomisation, controlled for baseline.

Additional/ secondary outcome measures will include: The Action Arm Research Test (ARAT), Apple watch activity monitors (implementing tailor-made machine learning methods to interpret UL movement data), Barthel Index (BI), Modified Rankin Scale (mRS), Hospital Anxiety and Depression Scale (HADS), Faces Pain Rating Scale (FPRS), Stanford Fatigue Visual Numeric Scale (SFVNS).

Assessments administered for the purpose of sample description (sub group analysis) and stratification will include: National Institutes of Health Stroke Scale (NIHSS), Edinburgh Handedness Scale (EHS), Montreal Cognitive Assessment (MOCA), Likert scale participant feedback forms (devised for the purposes of the current study). For purposively sampled sub-groups of participants, sub studies will explore bilateral naturalistic UL activity patterns in free living (intervention and control groups) and qualitative interviews will examine the mechanisms of behavioral change as relevant to the intervention (intervention group only).

Population: A convenience sample of 72 stroke survivors will be screened and consented by delegated health care practitioners (HCPs) or researchers at participating sites (i.e Co-Investigators (Co-Is)). Co-Is will also be invited to complete end-point feedback forms.

Eligibility: Participants will be 18yrs or over, acute/sub-acute stroke survivors with new UL impairment, fitting inclusion criteria specified herewith.

Duration: Participants' enrolment in the study will last up to 6months. The study recruitment phase will open for a total of 12months. The overall research period, including analysis and write up is anticipated to last 21months. ;

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

• NCT number: NCT04475692
• Study type: Interventional
• Source: Imperial College London
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Completion date: June 30, 2023