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

Stroke Clinical Trial

Official title:

Examination of Therapeutic Intervention Methods on the Brain Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721668
• Other study ID #: REB1213
• 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

• Paresis
• Stroke
• Upper Extremity Paresis

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