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

• Sponsor: Atrium Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00643864
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Duration (Months): 72
• Patients Per Site Per Month: 0

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: mirror training	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Feb 1, 2006
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Other: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. The Fugl-Meyer Assessment of Motor Function After Stroke [preintervention and post intervention]

   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

1. Arm Motor Ability Test [preintervention and post intervention]

   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.

2. Arm Motor Ability Test - Timed [pre intervention and post intervention]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Carolinas Rehabilitation	Charlotte	North Carolina	United States	28203

Sponsors and Collaborators

• Atrium Health

Investigators

• Principal Investigator: Mark A Hirsch, PhD, CHS
• Study Director: Flora M Hammond, MD, CHS

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Mark Hirsch, Research Scientist, Atrium Health
• ClinicalTrials.gov Identifier: NCT00643864
• Other Study ID Numbers: 12-05-14B
• First Posted: Mar 26, 2008
• Last Update Posted: Aug 5, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Mark Hirsch, Research Scientist, Atrium Health: mirror training; stroke; hemiparesis; rehabilitation
• Additional relevant MeSH terms: Stroke; Paresis

Study Results

Participant Flow

Recruitment Details	Medical outpatient clinic

Arm/Group Title	Mirror Training
Arm/Group Description	Training will be performed one hour a day, five days per week, Monday through Friday, for four weeks.
Period Title: Pre-test Assessment
STARTED	3
COMPLETED	3
NOT COMPLETED	0
Period Title: Pre-test Assessment
STARTED	3
COMPLETED	3
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Mirror Training
Arm/Group Description	Training will be performed one hour a day, five days a week, Monday through friday, for four weeks.
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	2 66.7%
Male	1 33.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 33.3%
White	2 66.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	3 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mirror Training
Arm/Group Description	one group pre post design
Measure Participants	3
Fugl-Meyer Pre	45.8 (12.6)
Fugl-Meyer Post	58 (0)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mirror Training
Arm/Group Description	one group pre post design
Measure Participants	3
Functional Ability Pre	92.8 (34.8)
Quality Scale Pre	90.1 (33.5)
Functional Ability Post	98.5 (53.0)
Quality Scale Post	94.5 (54.4)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

One group pre post design

Arm/Group Title	Mirror Training
Arm/Group 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.
Measure Participants	3
pre intervention	330.7 (355.4)
post intervention	249.8 (257.2)

Adverse Events

Time Frame	20 days
Arm/Group Title	Mirror Training
Arm/Group Description	Training will be performed one hour a day, five days per week, Monday through Friday, for four weeks.
All Cause Mortality
	Mirror Training
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Serious Adverse Events
	Mirror Training
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	Mirror Training
	Affected / at Risk (%)	# Events
Total	0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.