Back to resultsMirror-Box Training in Adults With Chronic Hemiparesis Secondary to Stroke
Primary Purpose
Stroke
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mirror training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring mirror training, stroke, hemiparesis, rehabilitation
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
Sites / Locations
- Carolinas Rehabilitation
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mirror training
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Arm Motor Ability Test
The Arm Motor Ability Test evaluates disabilities in upper extremity function in activities of daily living using a quantitative and qualitative measure. The Functional Ability Scale and the Quality of Movement Scale are rated on an ordinal scale from 0-5. The score for the Functional Ability Scale ranges from 0 to 140. The score for the Quality of Movement Scale ranges from 0 to 140. Higher scores on the Functional Ability and Quality Scale of the Arm Motor Ability Test indicate more normal movement and a better outcome.
Arm Motor Ability Test - Timed
The time in seconds to complete 28 tasks is recorded. The tasks are: 1 pick up utensils, 2 cut meat, 3 fork to mouth, 4 pick up sandwich, 5 sandwich to mouth, 6 pick up spoon, 7 bean in spoon, 8 spoon to mouth, 9 grasp mug handle, 10 mug to mouth, 11pick up comb, 12 comb hair, 13 grasp jar top, 14 open jar, 15 tie lace, 16 phone to ear, 17 press phone number, 18 wipe up water, 19 throw away towel, 20 paretic arm in sleeve, 21 button two buttons, 22 arms in T-shirt, 23 shirt over head, 24 straighten shirt, 25 prop on extended arm, 26 turn on light, 27 open door, 28 close door. The total time in seconds to complete all 28 tasks is recorded - as a total summary score. There is no minimum value. There is no maximum value. Lower scores (e.g., less time to complete the 28 tasks) indicate faster performance and better outcome.
Full Information
NCT ID
NCT00643864
First Posted
March 20, 2008
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00643864
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollment
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
mirror training, stroke, hemiparesis, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mirror training
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mirror training
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Fugl-Meyer Assessment of Motor Function After Stroke
Description
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.
Time Frame
preintervention and post intervention
Secondary Outcome Measure Information:
Title
Arm Motor Ability Test
Description
The Arm Motor Ability Test evaluates disabilities in upper extremity function in activities of daily living using a quantitative and qualitative measure. The Functional Ability Scale and the Quality of Movement Scale are rated on an ordinal scale from 0-5. The score for the Functional Ability Scale ranges from 0 to 140. The score for the Quality of Movement Scale ranges from 0 to 140. Higher scores on the Functional Ability and Quality Scale of the Arm Motor Ability Test indicate more normal movement and a better outcome.
Time Frame
preintervention and post intervention
Title
Arm Motor Ability Test - Timed
Description
The time in seconds to complete 28 tasks is recorded. The tasks are: 1 pick up utensils, 2 cut meat, 3 fork to mouth, 4 pick up sandwich, 5 sandwich to mouth, 6 pick up spoon, 7 bean in spoon, 8 spoon to mouth, 9 grasp mug handle, 10 mug to mouth, 11pick up comb, 12 comb hair, 13 grasp jar top, 14 open jar, 15 tie lace, 16 phone to ear, 17 press phone number, 18 wipe up water, 19 throw away towel, 20 paretic arm in sleeve, 21 button two buttons, 22 arms in T-shirt, 23 shirt over head, 24 straighten shirt, 25 prop on extended arm, 26 turn on light, 27 open door, 28 close door. The total time in seconds to complete all 28 tasks is recorded - as a total summary score. There is no minimum value. There is no maximum value. Lower scores (e.g., less time to complete the 28 tasks) indicate faster performance and better outcome.
Time Frame
pre intervention and post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Hirsch, PhD
Organizational Affiliation
CHS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flora M Hammond, MD
Organizational Affiliation
CHS
Official's Role
Study Director
Facility Information:
Facility Name
Carolinas Rehabilitation
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.carolinasmedicalcenter.org/body.cfm?id=1571
Description
Related Info
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Mirror-Box Training in Adults With Chronic Hemiparesis Secondary to Stroke
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