Improving Arm and Hand Functions in Chronic Stroke (CIHR 2012-2015)
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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 Physical 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 |
- 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.
- 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 Physical Therapy)
Experimental: CPT (Conventional Physical 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 Physical 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 |
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| Contact: Deirdre R Dawson, PhD | 416-785-2500 ext 2136 | ddawson@research.baycrest.org |
| Canada, Ontario | |
| Baycrest Centre for Geriatric Care | Recruiting |
| Toronto, Ontario, Canada, M6A2E1 | |
| Contact: Pratika Bandari, BSc 416-785-2500 ext 3377 pbandari@research.baycrest.org | |
| Principal Investigator: Deirdre D Dawson, PhD | |
| Principal Investigator: Bernhard Ross, PhD | |
| 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: | November 5, 2012 |
| 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 May 19, 2013