Stroke Clinical Trial
Official title:
Examination of Therapeutic Intervention Methods on the Brain Recovery
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Baycrest Centre for Geriatric Care | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Baycrest |
Canada,
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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