Clinical trial NCT00643864: Mirror-Box Training in Adults With Chronic Hemiparesis Secondary to Stroke
Official title: Mirror-Box Training in Adults With Chronic Hemiparesis Secondary to Stroke: A Descriptive Case Series and Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: mirror training
stroke
hemiparesis
rehabilitation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 3
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: The Fugl-Meyer Assessment of Motor Function After Stroke
timeFrame: preintervention and post intervention
Secondary outcomes:
measure: Arm Motor Ability Test
timeFrame: preintervention and post intervention
measure: Arm Motor Ability Test - Timed
timeFrame: pre intervention and post intervention
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Rehabilitation
state: North Carolina
Study officials:
affiliation: CHS
name: Mark A Hirsch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHS
name: Flora M Hammond, MD
role: STUDY_DIRECTOR
References: