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

NCT00643864 | Terminated Results DMC

• 1 other identifier: 12-05-14B
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Keywords

mirror training; stroke; hemiparesis; rehabilitation

Outcome Measures

Primary Outcomes (1)

• The Fugl-Meyer Assessment of Motor Function After Stroke

  The Fugl-Meyer Assessment of Motor Function After Stroke, a widely used scale of motor recovery after stroke. The subscale upper extremity motor function was used. This test requires progressively more complex movements and hand grasps and measure speed and coordination. Each item is graded on a 3-point ordinal scale (0=cannot perform; 1=partially performs; 2=performs fully) with a minimum score of 0 and a maximum score of 66 for the upper extremity. Higher scores indicate better outcome.

  preintervention and post intervention

Secondary Outcomes (2)

• Arm Motor Ability Test

  preintervention and post intervention

• Arm Motor Ability Test - Timed

  pre intervention and post intervention

Study Arms (1)

Mirror training

OTHER

Training will be performed one-on-one by an investigator in a quiet room, one hour a day, five days a week, for four weeks. The mirror-box apparatus consists of an 18" x 24" vertical mirror secured in the center of a wooden platform. During training, the mirror-box will be placed on a table in front of the subject so that the mirror is perpendicular to the chest, slightly lateral of midline. Subjects will be asked to attend to the mirror reflection of their unaffected hand performing a series of tasks, while keeping their affected limb still. At the end of the four week training period, posttests will be administered by the same therapist who performed the pretests.

Behavioral: mirror training

Interventions

mirror training BEHAVIORAL

Training will be performed one-on-one by an investigator in a quiet room, one hour a day, five days a week, for four weeks. Attendance will be recorded. The mirror-box apparatus consists of an 18" x 24" vertical mirror secured in the center of a wooden platform. During training, the mirror-box will be placed on a table in front of the subject so that the mirror is perpendicular to the chest, slightly lateral of midline. Subjects will be asked to attend to the mirror reflection of their unaffected hand performing a series of tasks, while keeping their affected limb still. At the end of the four week training period, posttests will be administered by the same Occupational Therapist who performed the pretests.

Mirror training

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Mark Hirsch, Senior Scientist
• Organization: CarolinasHS

mark.hirsch@carolinashealthcare.org

704 355 7673

Study Officials

• Mark A Hirsch, PhD

  CHS

  PRINCIPAL INVESTIGATOR

• Flora M Hammond, MD

  CHS

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: March 26, 2008
• Study Start: February 1, 2006
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 21, 2022
• Results First Posted: August 5, 2019

Record last verified: 2019-08

Locations

US (1)