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

Primary Purpose

Stroke, Upper Extremity Paresis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Music Supported Rehabilitation
Conventional Upper Extremity Therapy
Sponsored by
Baycrest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baycrest Centre for Geriatric Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MSR - Music Supported Rehabilitation

CU/ET

Arm Description

Behavioral: Music Supported Rehabilitation

Experimental: CU/ET (Conventional Upper Extremity Therapy)

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Brain structure
Structural MRI
Brain Function
Brain functions related to sensory and motor systems assessed by MEG

Full Information

First Posted
November 1, 2012
Last Updated
August 3, 2016
Sponsor
Baycrest
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1. Study Identification

Unique Protocol Identification Number
NCT01721668
Brief Title
Improving Arm and Hand Functions in Chronic Stroke (CIHR 2012-2015)
Official Title
Examination of Therapeutic Intervention Methods on the Brain Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baycrest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Paresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MSR - Music Supported Rehabilitation
Arm Type
Experimental
Arm Description
Behavioral: Music Supported Rehabilitation
Arm Title
CU/ET
Arm Type
Active Comparator
Arm Description
Experimental: CU/ET (Conventional Upper Extremity Therapy)
Intervention Type
Behavioral
Intervention Name(s)
Music Supported Rehabilitation
Intervention Description
Music Supported Rehabilitation -using musical exercises to improve hand and arm motor functioning.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Upper Extremity Therapy
Intervention Description
-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.
Primary Outcome Measure Information:
Title
Change in performance on Action Research Arm Test
Description
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.
Time Frame
Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
Title
Change in performance on Chedoke Arm and Hand Inventory
Description
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.
Time Frame
Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
Title
Change in status on Stroke Impact Scale
Description
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.
Time Frame
Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
Secondary Outcome Measure Information:
Title
Brain structure
Description
Structural MRI
Time Frame
Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up
Title
Brain Function
Description
Brain functions related to sensory and motor systems assessed by MEG
Time Frame
Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deirdre R Dawson, PhD
Organizational Affiliation
Baycrest
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernhard Ross, PhD
Organizational Affiliation
Baycrest
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Takako Fujioka, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baycrest Centre for Geriatric Care
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A2E1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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