Improving Arm and Hand Functions in Chronic Stroke (CIHR 2012-2015)

Not Applicable

Completed

• Conditions: Stroke; Upper Extremity Paresis
• Interventions: Behavioral: Music Supported Rehabilitation; Behavioral: Conventional Upper Extremity Therapy

• Registration Number: NCT01721668
• Lead Sponsor: Baycrest

Brief Summary

Improving arm and hand function after stroke has been difficult to achieve within the rehabilitation service provided in the acute stage often due to the limited resource in health care. While spontaneous recovery plateaus after 6 months, the prolonged disability affects quality of life and social participation in stroke survivors. This study is aimed at improving chronic motor impairment arm and hand impairment by providing the intervention with intensive training schedule. This study will compare two types of rehabilitation intervention using a randomized controlled trial. Measurements also will be taken on various brain functions non-invasively to help discover how each of the intervention strategies works differently to repair the brain.

Detailed Description

After unilateral stroke, incomplete recovery of arm and hand movement is common and its long-lasting negative effects include increased care giving costs and overall reduced quality of life. Recent evidence suggests that a novel behavioral intervention could improve motor functions in sub-acute patients with added benefits in cognitive and brain functions. However few studies have addressed whether chronic stage patients can also benefit from the intervention and how brain plasticity works over the course of rehabilitation. This study will investigate the benefits of two types of intervention methods that are extendable for community-based intervention services in the future. It also will examine changes in integrity of motions before and after the intervention. Further comparisons between brain functions and structure will be made using magnetoencephalography (MEG) and magnetic resonance imaging (MRI), non-invasively. These behavioural and physiological measures will inform the mechanisms of stroke recovery and training.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-05
• Study First Posted: 2012-11-06
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• post-acute stroke patients with unilateral first-time MCA stroke sustained . (more than 6 months ago prior to the enrolment to the study).
• Patients' residual motor impairments in the affected hand and arm should be greater than stage 3 on the Chedoke McMaster scale.

Exclusion Criteria

• Patients with moderate apraxia, aphasia or dementia, and patients with severe sensory loss in the paretic hand, severe language-communication disability, posture problems, involuntary movements, high-blood pressure, depression or other psychological disorders, metal in body that interferes with MEG and MRI measurements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSR - Music Supported Rehabilitation	Music Supported Rehabilitation	Behavioral: Music Supported Rehabilitation
CU/ET	Conventional Upper Extremity Therapy	Experimental: CU/ET (Conventional Upper Extremity Therapy)

Primary Outcome Measures

Name	Time	Method
Change in performance on Chedoke Arm and Hand Inventory	Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up	Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.
Change in performance on Action Research Arm Test	Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up	Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.
Change in status on Stroke Impact Scale	Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up	Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.

Secondary Outcome Measures

Name	Time	Method
Brain structure	Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up	Structural MRI
Brain Function	Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up	Brain functions related to sensory and motor systems assessed by MEG

Trial Locations

Locations (1)

Baycrest Centre for Geriatric Care; 🇨🇦 Toronto, Ontario, Canada