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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Baycrest
Sponsor:
Information provided by (Responsible Party):
Deirdre Dawson, Baycrest
ClinicalTrials.gov Identifier:
NCT01721668
First received: November 1, 2012
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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
Stroke Patients With Hemiparetic Arm/Hand Functions
Behavioral: Music Supported Rehabilitation
Behavioral: Conventional Upper Extremity Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Structural MRI

  • Brain Function [ Time Frame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up ] [ Designated as safety issue: No ]
    Brain functions related to sensory and motor systems assessed by MEG


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MSR (Music Supported Rehabilitation)
Behavioral: Music Supported Rehabilitation Using musical exercises to improve hand and arm motor functioning.
Behavioral: Music Supported Rehabilitation
Experimental: CPT (Conventional Upper Extremity Therapy)

Experimental: CPT (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.

Behavioral: Conventional Upper Extremity Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721668

Contacts
Contact: Deirdre R Dawson, PhD 416-785-2500 ext 2136 ddawson@research.baycrest.org

Locations
Canada, Ontario
Baycrest Centre for Geriatric Care Recruiting
Toronto, Ontario, Canada, M6A2E1
Contact: Rebecca Wright, BMT    416-785-2500 ext 5626    rwright@research.baycrest.org   
Principal Investigator: Deirdre D Dawson, PhD         
Principal Investigator: Bernhard Ross, PhD         
Sponsors and Collaborators
Baycrest
Investigators
Principal Investigator: Deirdre R Dawson, PhD Baycrest
Principal Investigator: Bernhard Ross, PhD Baycrest
Principal Investigator: Takako Fujioka, PhD Stanford University
  More Information

No publications provided

Responsible Party: Deirdre Dawson, Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute, Baycrest
ClinicalTrials.gov Identifier: NCT01721668     History of Changes
Other Study ID Numbers: REB1213
Study First Received: November 1, 2012
Last Updated: January 8, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 29, 2014