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

This study has been terminated.
(lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Mark Hirsch, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00643864
First received: March 20, 2008
Last updated: February 9, 2012
Last verified: February 2012
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 3
Study Start Date: February 2006
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: motor training
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Mark Hirsch, Research Scientist, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT00643864     History of Changes
Other Study ID Numbers: 12-05-14B
Study First Received: March 20, 2008
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 24, 2014