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NCT Number: NCT01721668

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Extremity Paresis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baycrest Centre for Geriatric Care

Toronto, Ontario, M6A2E1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music Supported Rehabilitation

Behavioral

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

Conventional Upper Extremity Therapy

Behavioral

-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 outcomes

  1. Change in performance on Action Research Arm Test

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Brain structure

    Time frame: Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up

    Structural MRI

  2. Brain Function

    Time frame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up

    Brain functions related to sensory and motor systems assessed by MEG

Sponsors and collaborators

Lead sponsor

Baycrest

Other

Registry information

Official study title

Examination of Therapeutic Intervention Methods on the Brain Recovery

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2012
Registry last updated
Aug 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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