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

NCT ID: NCT00643864

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2012-02-29

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mirror training

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.

Group Type: OTHER

mirror training

Intervention Type: 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.

Interventions

mirror training

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark A Hirsch, PhD

Role: PRINCIPAL_INVESTIGATOR

CHS

Flora M Hammond, MD

Role: STUDY_DIRECTOR

CHS

Locations

Carolinas Rehabilitation

Charlotte, North Carolina, United States

Countries

United States

Related Links

http://www.carolinasmedicalcenter.org/body.cfm?id=1571

Related Info

Other Identifiers

12-05-14B

Identifier Type: -

Identifier Source: org_study_id