StrokeNCT00643864
Mirror-Box Training in Adults With Chronic Hemiparesis Secondary to Stroke
A study testing mirror training in people with Stroke, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- mirror training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Rehabilitation
Charlotte, North Carolina, 28203
About this study
Official title: Mirror-Box Training in Adults With Chronic Hemiparesis Secondary to Stroke: A Descriptive Case Series and Pilot Study
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).
Read the 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
- Being tested
- mirror training
- Keywords
- mirror training, stroke, hemiparesis, rehabilitation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: mirror training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: preintervention and post intervention
Secondary outcomes (2)
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.
Measured: preintervention and post intervention
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.
Measured: pre intervention and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startFeb 2006
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A Hirsch, PhD, Principal investigator, CHSFlora M Hammond, MD, Study director, CHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643864
- Sponsor's protocol ID
- 12-05-14B
- Status last verified
- Aug 2019
- First submitted
- 20 Mar 2008
- Last updated
- 21 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirror-Box Training in Adults With Chronic Hemiparesis Secondary to Stroke: A Descriptive Case Series and Pilot Study
- ClinicalTrials.gov ID
- NCT00643864
- Acronym / sponsor ID
- 12-05-14B
- Conditions
- Stroke
- Keywords
- mirror training, stroke, hemiparesis, rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirror training | Other | Behavioral: mirror trainingTraining 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirror trainingTraining 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. | Behavioural | Mirror training |
Primary outcome
The Fugl-Meyer Assessment of Motor Function After Stroke
Time frame: 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.
2 secondary outcomes
Arm Motor Ability Test
Time frame: preintervention and post intervention
Arm Motor Ability Test - Timed
Time frame: pre intervention and post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Hirsch, PhD principal investigator
CHS
Flora M Hammond, MD study director
CHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mirror training in people with Stroke, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fugl-Meyer Assessment of Motor Function After Stroke (time frame: preintervention and post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.