Mirror-Box Training in Adults With Chronic Hemiparesis Secondary to Stroke - Full Text View

Sponsored by:	Carolinas Healthcare System
Information provided by:	Carolinas Healthcare System
ClinicalTrials.gov Identifier:	NCT00643864

Purpose

The purpose of this project is to assess the effects of four weeks of mirror-box training on weakness of one arm secondary to stroke. Primary measures are function and strength. Secondary measures will evaluate muscle tone, flexibility, and the subject's perception of their everyday function and improvement. Research Hypothesis: For chronic upper limb hemiparesis secondary to stroke, four weeks of mirror-box training with movement of the unaffected limb only results in a mean increase of 10 points on the Fugl-Meyer Test of Motor Recovery (Upper Extremity).

Condition	Intervention
Stroke	Behavioral: motor training

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Mirror-Box Training in Adults With Chronic Hemiparesis Secondary to Stroke: A Descriptive Case Series and Pilot Study

Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:

Fugl-Meyer Test of Motor Recovery, Upper Extremity [ Time Frame: preintervention and post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Arm Motor Ability Test [ Time Frame: preintervention and post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Mirror training and motor imagery

Detailed Description:

Due to the relatively new nature of mirror training, there are few randomized controlled studies. This pilot case series will serve as our initial step in trying to identify the frequency, duration, and treatment exercises needed in this population. Additionally, this pilot will allow us to ensure our outcome measures are appropriate to detect meaningful treatment changes. After obtaining informed consent, patients will undergo two separate baseline assessments of strength, function, and tone 4 weeks apart. Training sessions will consist of supervised activities using the unaffected arm while observing its mirror reflection; the affected arm will remain still. Sessions will be one hour a day, five days a week, for four weeks. Patients will be tested for strength, function and tone in the affected arm at completion of the four week treatment period by the same occupational therapist that performed the pretests.

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

First unilateral ischemic stroke resulting in hemiparesis at least 6 months prior to enrollment.
Age at time of enrollment: 30-80 years.
Voluntary informed consent of patient.
Patient willing to comply with protocol and is available for all scheduled visits.
Residual upper extremity hemiparesis.
No changes in medications planned during 8-week participation.
No other motor rehabilitative therapy during 8-week participation, including E-stim and acupuncture.
At least 20 degrees of active wrist extension and 10 degrees of active finger extension against gravity in the affected upper limb, as measured by goniometry.

Exclusion Criteria:

Serious cognitive deficits, as evidenced by score of <20 on Modified Mini-Mental Status Exam
Hemorrhagic or bilateral strokes
Excessive spasticity at the elbow, wrist, or hand, defined as a Modified Ashworth Scale score of >2
History of botulinum toxin injection in affected upper extremity in the past 4 months
Lacking >40 degrees of passive elbow extension
Less than 45 degrees of passive shoulder flexion
Global or receptive aphasia present on physical exam
Hemispatial neglect present on physical exam
Patient participating in constraint-induced therapy during study time period
Severe visual deficits or visual field deficits as determined by ability to ascertain number of fingers held up on visual field testing
Deformity/amputation of unaffected upper limb

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643864

Contacts

Contact: Vu Nguyen, MD

704-355-9330

Vu.Nguyen@carolinashealthcare.org

Locations

United States, North Carolina
Carolinas Rehabilitation	Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Mark A Hirsch, PhD
Principal Investigator: Mark A Hirsch, PhD

Sponsors and Collaborators

Carolinas Healthcare System

Investigators

Principal Investigator:	Mark A Hirsch, PhD	CHS
Study Director:	Flora M Hammond, MD	CHS

More Information

Responsible Party:	Carolinas Healthcare System ( Mark A. Hirsch, PhD., Research Faculty )
Study ID Numbers:	12-05-14B
Study First Received:	March 20, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00643864
Health Authority:	United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:

mirror training
stroke
hemiparesis
rehabilitation

Study placed in the following topic categories:

Paresis
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases

Cerebrovascular Disorders
Signs and Symptoms
Neoplasm Metastasis
Neurologic Manifestations
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009