Clinical trial NCT01721668: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Lead sponsor: Baycrest
Sponsor class: OTHER
First posted: 2012-11-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in performance on Action Research Arm Test
timeFrame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
measure: Change in performance on Chedoke Arm and Hand Inventory
timeFrame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
measure: Change in status on Stroke Impact Scale
timeFrame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
Secondary outcomes:
measure: Brain structure
timeFrame: Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up
measure: Brain Function
timeFrame: Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Centre for Geriatric Care
state: Ontario
Study officials:
affiliation: Baycrest
name: Deirdre R Dawson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baycrest
name: Bernhard Ross, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Takako Fujioka, PhD
role: PRINCIPAL_INVESTIGATOR
References: