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

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ClinicalTrials.gov Identifier: NCT00643864
Recruitment Status : Terminated (lack of enrollment)
First Posted : March 26, 2008
Last Update Posted : February 10, 2012
Sponsor:
Information provided by (Responsible Party):
Mark Hirsch, Carolinas Healthcare System

Brief Summary:
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 or disease Intervention/treatment
Stroke Behavioral: motor training

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mirror-Box Training in Adults With Chronic Hemiparesis Secondary to Stroke: A Descriptive Case Series and Pilot Study
Study Start Date : February 2006
Primary Completion Date : February 2012
Study Completion Date : February 2012

Intervention Details:
    Behavioral: motor training
    Mirror training and motor imagery


Primary Outcome Measures :
  1. Fugl-Meyer Test of Motor Recovery, Upper Extremity [ Time Frame: preintervention and post intervention ]

Secondary Outcome Measures :
  1. Arm Motor Ability Test [ Time Frame: preintervention and post intervention ]


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643864


Locations
United States, North Carolina
Carolinas Rehabilitation
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Mark A Hirsch, PhD CHS
Study Director: Flora M Hammond, MD CHS

Additional Information:
Responsible Party: Mark Hirsch, Research Scientist, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT00643864     History of Changes
Other Study ID Numbers: 12-05-14B
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012

Keywords provided by Mark Hirsch, Carolinas Healthcare System:
mirror training
stroke
hemiparesis
rehabilitation

Additional relevant MeSH terms:
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms