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Clinical Trials/NCT01721668
NCT01721668
Completed
Not Applicable

Examination of Therapeutic Intervention Methods on the Brain Recovery

Baycrest1 site in 1 country29 target enrollmentNovember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Baycrest
Enrollment
29
Locations
1
Primary Endpoint
Change in performance on Chedoke Arm and Hand Inventory
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Baycrest
Responsible Party
Principal Investigator
Principal Investigator

Dr. Deirdre Dawson

Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute

Baycrest

Eligibility 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.

Outcomes

Primary Outcomes

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 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 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 Outcomes

  • Brain structure(Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up)
  • Brain Function(Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up)

Study Sites (1)

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