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

NCT01721668 | Completed DMC

• 1 other identifier: REB1213
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Upper Extremity Paresis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• Brain structure

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

• Brain Function

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

Study Arms (2)

MSR - Music Supported Rehabilitation

EXPERIMENTAL

Behavioral: Music Supported Rehabilitation

Behavioral: Music Supported Rehabilitation

CU/ET

ACTIVE COMPARATOR

Experimental: CU/ET (Conventional Upper Extremity Therapy)

Behavioral: Conventional Upper Extremity Therapy

Interventions

Music Supported Rehabilitation BEHAVIORAL

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

MSR - Music Supported Rehabilitation

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.

CU/ET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baycrest: lead

Study Sites (1)

Baycrest Centre for Geriatric Care

Toronto, Ontario, M6A2E1, Canada

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Deirdre R Dawson, PhD

  Baycrest

  PRINCIPAL INVESTIGATOR

• Bernhard Ross, PhD

  Baycrest

  PRINCIPAL INVESTIGATOR

• Takako Fujioka, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 6, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 5, 2016

Record last verified: 2016-08

Locations

CA (1)