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

This study is currently recruiting participants.
Verified January 2014 by Baycrest
Sponsor:
Information provided by (Responsible Party):
Deirdre Dawson, Baycrest
ClinicalTrials.gov Identifier:
NCT01721668
First received: November 1, 2012
Last updated: January 8, 2014
Last verified: January 2014

November 1, 2012
January 8, 2014
November 2012
September 2015   (final data collection date for primary outcome measure)
  • Change in performance on Action Research Arm Test [ Time Frame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01721668 on ClinicalTrials.gov Archive Site
  • Brain structure [ Time Frame: Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up ] [ Designated as safety issue: No ]
    Structural MRI
  • Brain Function [ Time Frame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up ] [ Designated as safety issue: No ]
    Brain functions related to sensory and motor systems assessed by MEG
Same as current
Not Provided
Not Provided
 
Improving Arm and Hand Functions in Chronic Stroke (CIHR 2012-2015)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stroke Patients With Hemiparetic Arm/Hand Functions
  • Behavioral: Music Supported Rehabilitation
  • Behavioral: Conventional Upper Extremity Therapy
  • Experimental: MSR (Music Supported Rehabilitation)
    Behavioral: Music Supported Rehabilitation Using musical exercises to improve hand and arm motor functioning.
    Intervention: Behavioral: Music Supported Rehabilitation
  • Experimental: CPT (Conventional Upper Extremity Therapy)

    Experimental: CPT (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.

    Intervention: Behavioral: Conventional Upper Extremity Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
September 2015
September 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Deirdre R Dawson, PhD 416-785-2500 ext 2136 ddawson@research.baycrest.org
Canada
 
NCT01721668
REB1213
Yes
Deirdre Dawson, Baycrest
Baycrest
Not Provided
Principal Investigator: Deirdre R Dawson, PhD Baycrest
Principal Investigator: Bernhard Ross, PhD Baycrest
Principal Investigator: Takako Fujioka, PhD Stanford University
Baycrest
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP