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

NCT ID: NCT01721668

Last Updated: 2016-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Stroke Upper Extremity Paresis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MSR - Music Supported Rehabilitation

Behavioral: Music Supported Rehabilitation

Group Type EXPERIMENTAL

Music Supported Rehabilitation

Intervention Type BEHAVIORAL

Music Supported Rehabilitation -using musical exercises to improve hand and arm motor functioning.

CU/ET

Experimental: CU/ET (Conventional Upper Extremity Therapy)

Group Type ACTIVE_COMPARATOR

Conventional Upper Extremity Therapy

Intervention Type BEHAVIORAL

-GRASP (Graded Repetitive Arm Supplementary Program-developed Janice Eng, PhD, PT/OT Jocelyn Harris, PhD, OT, Andrew Dawson, MD, FRCP, Bill Miller, PhD, OT) protocol will be used to improve arm and hand function in people living with stroke.

Interventions

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Music Supported Rehabilitation

Music Supported Rehabilitation -using musical exercises to improve hand and arm motor functioning.

Intervention Type BEHAVIORAL

Conventional Upper Extremity Therapy

-GRASP (Graded Repetitive Arm Supplementary Program-developed Janice Eng, PhD, PT/OT Jocelyn Harris, PhD, OT, Andrew Dawson, MD, FRCP, Bill Miller, PhD, OT) protocol will be used to improve arm and hand function in people living with stroke.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baycrest

OTHER

Sponsor Role lead

Responsible Party

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Dr. Deirdre Dawson

Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deirdre R Dawson, PhD

Role: PRINCIPAL_INVESTIGATOR

Baycrest

Bernhard Ross, PhD

Role: PRINCIPAL_INVESTIGATOR

Baycrest

Takako Fujioka, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Baycrest Centre for Geriatric Care

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB1213

Identifier Type: -

Identifier Source: org_study_id

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