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

Sponsor
Baycrest (Other)
Overall Status
Completed
CT.gov ID
NCT01721668
Collaborator
(none)
29
1
2
40
0.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music Supported Rehabilitation
  • Behavioral: Conventional Upper Extremity Therapy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Examination of Therapeutic Intervention Methods on the Brain Recovery
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: MSR - Music Supported Rehabilitation

Behavioral: Music Supported Rehabilitation

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

Active Comparator: CU/ET

Experimental: CU/ET (Conventional Upper Extremity Therapy)

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Change in performance on Action Research Arm Test [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.

  2. Change in performance on Chedoke Arm and Hand Inventory [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.

  3. Change in status on Stroke Impact Scale [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 Outcome Measures

  1. Brain structure [Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up]

    Structural MRI

  2. Brain Function [Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up]

    Brain functions related to sensory and motor systems assessed by MEG

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baycrest Centre for Geriatric Care Toronto Ontario Canada M6A2E1

Sponsors and Collaborators

  • Baycrest

Investigators

  • Principal Investigator: Deirdre R Dawson, PhD, Baycrest
  • Principal Investigator: Bernhard Ross, PhD, Baycrest
  • Principal Investigator: Takako Fujioka, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Deirdre Dawson, Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute, Baycrest
ClinicalTrials.gov Identifier:
NCT01721668
Other Study ID Numbers:
  • REB1213
First Posted:
Nov 6, 2012
Last Update Posted:
Aug 5, 2016
Last Verified:
Aug 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2016