Cerebral Vascular Accident (CVA)NCT02780440
Comparing Unimanual and Bimanual Mirror Therapy for Upper Limb Recovery Post Stroke
An observational study of Cerebral Vascular Accident (CVA) and Stroke, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this randomized controlled study is to 1. Examine the feasibility of a home Mirror therapy (MT) program in the NYC metropolitan area; 2. Evaluate the effectiveness of home MT versus traditional home exercise program; and 3. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Cerebral Vascular Accident (CVA), Stroke
- What is being tested?
- Traditional Home Based Exercise Program, Unimanual Home Based Mirror Therapy Program and Bimanual Home Based Mirror Therapy Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants included in the study will be those referred to outpatient occupational therapy at the Ambulatory Care Center of NYU Langone Center with a diagnosis of cerebral vascular accident (CVA) or stroke.
Who may be able to join
- First time unilateral stroke > 3 months post stroke.
- Cognitively be able to follow direction
- Cognitively be able to consent to participation in research study
- Moderate/severe deficits as per the Fugl-Meyer assessment score from 10-50 and the ability to grasp and release a small towel or washcloth.
Who cannot join
- Complex medical problems, that would render the subject unable to participate in an extensive home program
- History of pre-existing neurological or psychiatric diseases, orthopedic conditions of the upper limbs, or peripheral nerve injuries that render the subject unable to sit or to move either upper limb
- Hearing and vision impairments which may impede subjects participation in the home program
- Perceptual deficits such as apraxia, neglect, or agnosias as per clinical evaluation which may impede subjects participation in the home program
- Botox injection in affected arm/hand within 3 months
- Global aphasia that may interfere with understanding instruction for testing or home exercise program.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Home Mirror Therapy: A Randomized Control Study Comparing Unimanual and Bimanual Mirror Therapy for Improved Hand Function Post-stroke
The purpose of this randomized controlled study is to
- Examine the feasibility of a home Mirror therapy (MT) program in the NYC metropolitan area;
- Evaluate the effectiveness of home MT versus traditional home exercise program; and
- Evaluate the superiority of unimanual or bimanual MT intervention protocols for chronic stroke subjects with moderate hand deficits. Subjects from occupational therapy at the Ambulatory Care Center of NYU Langone Center with a diagnosis of cerebral vascular accident (CVA) or stroke will be divided into three (3) groups:
- Control Group subjects will participate in standard occupational therapy rehabilitation protocol plus a traditional home based exercise program.
- Experimental group 1 subjects will participate in standard rehabilitation protocol plus unimanual home based mirror therapy program
- Experimental group 2 subjects will participate in standard rehabilitation protocol plus bimanual home based mirror therapy program.
- Conditions
- Cerebral Vascular Accident (CVA), Stroke
- Being tested
- Traditional Home Based Exercise Program, Unimanual Home Based Mirror Therapy Program, Bimanual Home Based Mirror Therapy Program
- Keywords
- Post Stroke Recovery, Mirror Therapy, Unimanual mirror therapy, Bimanual mirror therapy, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Home Based Exercise ProgramBehavioural
Subjects in the control group will receive a traditional home Occupational Training exercise program as per conventional OT guidelines with the same home program duration.
Unimanual Home Based Mirror Therapy ProgramBehavioural
The affected hand will remain still in the mirror box, the unaffected hand will perform the exercises while the subject watches the mirror reflection.
Bimanual Home Based Mirror Therapy ProgramBehavioural
The affected hand in the mirror box will best mimic the unaffected hand, while also watching the mirror reflection.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Subjects will participate in standard occupational therapy rehabilitation protocol plus a traditional home based exercise program. Receives: Behavioral: Traditional Home Based Exercise Program | |
| Experimental Group 1 | Subjects will participate in standard rehabilitation protocol plus unimanual home based mirror therapy program Receives: Behavioral: Unimanual Home Based Mirror Therapy Program | |
| Experimental Group 2 | Subjects will participate in standard rehabilitation protocol plus bimanual home based mirror therapy program. Receives: Behavioral: Bimanual Home Based Mirror Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
Gold Standard to evaluate and measure recovery in patients with hemiplegia post stroke.
Measured: Baseline to Six (6) Weeks
Grip strength
Grip strength is important to measure as it is correlated with stroke recovery.
Measured: Baseline to Six (6) Weeks
Action Research Arm Test (ARAT)
An interview based tool that measures a subject's perceived difficulty with the use of their arm/hands with activities of daily living post-stroke.
Measured: Baseline to Six (6) Weeks
Stroke Impact Scale Version 3.0
A subjective standardized 59-items 8 domain questionnaire assessing health status post-stroke.
Measured: Baseline to Six (6) Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startNov 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Vascular Accident (CVA)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Vanlew, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780440
- Sponsor's protocol ID
- 14-01859
- Status last verified
- May 2019
- First submitted
- 19 May 2016
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Geller D, Nilsen DM, Quinn L, Van Lew S, Bayona C, Gillen G. Home mirror therapy: a randomized controlled pilot study comparing unimanual and bimanual mirror therapy for improved arm and hand function post-stroke. Disabil Rehabil. 2022 Nov;44(22):6766-6774. doi: 10.1080/09638288.2021.1973121. Epub 2021 Sep 19.
PubMed 34538193
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Mirror Therapy: A Randomized Control Study Comparing Unimanual and Bimanual Mirror Therapy for Improved Hand Function Post-stroke
- ClinicalTrials.gov ID
- NCT02780440
- Acronym / sponsor ID
- 14-01859
- Conditions
- Cerebral Vascular Accident (CVA), Stroke
- Keywords
- Post Stroke Recovery, Mirror Therapy, Unimanual mirror therapy, Bimanual mirror therapy, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 23 May 2016 (estimated)
- Results
- Not posted in the source record
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 randomized controlled study is to
- Examine the feasibility of a home Mirror therapy (MT) program in the NYC metropolitan area;
- Evaluate the effectiveness of home MT versus traditional home exercise program; and
- Evaluate the superiority of unimanual or bimanual MT intervention protocols for chronic stroke subjects with moderate hand deficits. Subjects from occupational therapy at the Ambulatory Care Center of NYU Langone Center with a diagnosis of cerebral vascular accident (CVA) or stroke will be divided into three (3) groups:
- Control Group subjects will participate in standard occupational therapy rehabilitation protocol plus a traditional home based exercise program.
- Experimental group 1 subjects will participate in standard rehabilitation protocol plus unimanual home based mirror therapy program
- Experimental group 2 subjects will participate in standard rehabilitation protocol plus bimanual home based mirror therapy program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Behavioral: Traditional Home Based Exercise ProgramSubjects will participate in standard occupational therapy rehabilitation protocol plus a traditional home based exercise program. |
| Experimental Group 1 | – | Behavioral: Unimanual Home Based Mirror Therapy ProgramSubjects will participate in standard rehabilitation protocol plus unimanual home based mirror therapy program |
| Experimental Group 2 | – | Behavioral: Bimanual Home Based Mirror Therapy ProgramSubjects will participate in standard rehabilitation protocol plus bimanual home based mirror therapy program. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants included in the study will be those referred to outpatient occupational therapy at the Ambulatory Care Center of NYU Langone Center with a diagnosis of cerebral vascular accident (CVA) or stroke.
Key inclusion criteria (4 listed)
- First time unilateral stroke > 3 months post stroke.
- Cognitively be able to follow direction
- Cognitively be able to consent to participation in research study
- Moderate/severe deficits as per the Fugl-Meyer assessment score from 10-50 and the ability to grasp and release a small towel or washcloth.
Key exclusion criteria (6 listed)
- Complex medical problems, that would render the subject unable to participate in an extensive home program
- History of pre-existing neurological or psychiatric diseases, orthopedic conditions of the upper limbs, or peripheral nerve injuries that render the subject unable to sit or to move either upper limb
- Hearing and vision impairments which may impede subjects participation in the home program
- Perceptual deficits such as apraxia, neglect, or agnosias as per clinical evaluation which may impede subjects participation in the home program
- Botox injection in affected arm/hand within 3 months
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 |
|---|---|---|
| Traditional Home Based Exercise ProgramSubjects in the control group will receive a traditional home Occupational Training exercise program as per conventional OT guidelines with the same home program duration. | Behavioural | Control Group |
| Unimanual Home Based Mirror Therapy ProgramThe affected hand will remain still in the mirror box, the unaffected hand will perform the exercises while the subject watches the mirror reflection. | Behavioural | Experimental Group 1 |
| Bimanual Home Based Mirror Therapy ProgramThe affected hand in the mirror box will best mimic the unaffected hand, while also watching the mirror reflection. | Behavioural | Experimental Group 2 |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: Baseline to Six (6) Weeks
Gold Standard to evaluate and measure recovery in patients with hemiplegia post stroke.
Grip strength
Time frame: Baseline to Six (6) Weeks
Grip strength is important to measure as it is correlated with stroke recovery.
Action Research Arm Test (ARAT)
Time frame: Baseline to Six (6) Weeks
An interview based tool that measures a subject's perceived difficulty with the use of their arm/hands with activities of daily living post-stroke.
Stroke Impact Scale Version 3.0
Time frame: Baseline to Six (6) Weeks
A subjective standardized 59-items 8 domain questionnaire assessing health status post-stroke.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Derived from this study: PubMed 34538193Geller D, Nilsen DM, Quinn L, Van Lew S, Bayona C, Gillen G. Home mirror therapy: a randomized controlled pilot study comparing unimanual and bimanual mirror therapy for improved arm and hand function post-stroke. Disabil Rehabil. 2022 Nov;44(22):6766-6774. doi: 10.1080/09638288.2021.1973121. Epub 2021 Sep 19.
Related trials for Cerebral Vascular Accident (CVA)
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.
Steve Vanlew, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Vascular Accident (CVA) and Stroke, run by NYU Langone Health 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 10 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fugl-Meyer Assessment (FMA) (time frame: Baseline to Six (6) Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02780440, which also lists 1 linked publication.
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 10 May 2019.