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

This study has been completed.
Information provided by (Responsible Party):
Dr. Deirdre Dawson, Baycrest Identifier:
First received: November 1, 2012
Last updated: August 3, 2016
Last verified: August 2016
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.

Condition Intervention
Upper Extremity Paresis
Behavioral: Music Supported Rehabilitation
Behavioral: Conventional Upper Extremity Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examination of Therapeutic Intervention Methods on the Brain Recovery

Resource links provided by NLM:

Further study details as provided by Baycrest:

Primary Outcome Measures:
  • Change in performance on Action Research Arm Test [ Time Frame: 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 Chedoke Arm and Hand Inventory [ Time Frame: 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 [ Time Frame: 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:
  • Brain structure [ Time Frame: Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up ]
    Structural MRI

  • Brain Function [ Time Frame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up ]
    Brain functions related to sensory and motor systems assessed by MEG

Enrollment: 29
Study Start Date: November 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MSR - Music Supported Rehabilitation
Behavioral: Music Supported Rehabilitation
Behavioral: Music Supported Rehabilitation
Music Supported Rehabilitation -using musical exercises to improve hand and arm motor functioning.
Active Comparator: CU/ET
Experimental: CU/ET (Conventional Upper Extremity Therapy)
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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01721668

Canada, Ontario
Baycrest Centre for Geriatric Care
Toronto, Ontario, Canada, M6A2E1
Sponsors and Collaborators
Principal Investigator: Deirdre R Dawson, PhD Baycrest
Principal Investigator: Bernhard Ross, PhD Baycrest
Principal Investigator: Takako Fujioka, PhD Stanford University
  More Information

Responsible Party: Dr. Deirdre Dawson, Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute, Baycrest Identifier: NCT01721668     History of Changes
Other Study ID Numbers: REB1213
Study First Received: November 1, 2012
Last Updated: August 3, 2016

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on May 25, 2017