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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01721668
Other study ID # REB1213
Secondary ID
Status Completed
Phase N/A
First received November 1, 2012
Last updated August 3, 2016
Start date November 2012
Est. completion date March 2016

Study information

Verified date August 2016
Source Baycrest
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review CommitteeCanada: Canadian Institutes of Health Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Baycrest Centre for Geriatric Care Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Baycrest

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in performance on Action Research Arm Test 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. Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up No
Primary Change in performance on Chedoke Arm and Hand Inventory 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. Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up No
Primary Change in status on Stroke Impact Scale 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. Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up No
Secondary Brain structure Structural MRI Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up No
Secondary Brain Function Brain functions related to sensory and motor systems assessed by MEG Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up No
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