HemiparesisNCT01662960

Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

A study testing Mirror therapy and Divider therapy in people with Hemiparesis and Stroke, run by Albert Einstein Healthcare Network at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home. Read more about this study

Who is it for?: Ages 21 to 85 years
Conditions the study is for: Hemiparesis, Stroke
What is being tested?: Mirror therapy and Divider therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: 7 Sep 2012to 27 Feb 2017
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 21 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

6 months or more post-stroke
upper extremity Fugl-Meyer score between 10 and 50
no longer participating in upper-extremity physical or occupational therapy
sufficient comprehension ability to understand instructions

Who cannot join

previous head trauma, psychiatric illness or chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g., haloperidol, dopaminergics)
dementia

Trial locations and contacts

1 site in 1 country.

United States1 site

Einstein Medical Center Elkins Park
Elkins Park, Pennsylvania, 19027

Other trials in United States

About this study

The purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.

Read the detailed description

This study will compare two forms of home-based treatment for post-stroke problems making movements with the arms and hands. After initial pre-treatment assessments, participants will complete 4 weeks of treatment, with assessments after each week of treatment and 3 months after the completion of treatment.

Conditions: Hemiparesis, Stroke
Being tested: Mirror therapy, Divider therapy
Keywords: stroke, hemiparesis, arm movement, sensory functioning
Medical subject headings: Paresis, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mirror therapyBehavioural
A home-based therapy involving mirrored visual feedback
Divider therapyBehavioural
A home-based therapy involving removed visual feedback.

Study groups in NCT01662960
Study group	Role	What they receive
Mirror therapy	Experimental	4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm. Receives: Behavioral: Mirror therapy
Divider therapy	Active comparator	4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm. Receives: Behavioral: Divider therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Upper Extremity Fugl-Meyer
This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.
Measured: Immediately after 1 month of treatment
Action Research Arm Test
The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.
Measured: 1 month
Rivermead Assessment of Somatosensory Performance
This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.
Measured: 1 month
Virtual-reality Assessment of Navigation
This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.
Measured: 1 month

Secondary outcomes (2)

Stroke Impact Scale
This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.
Measured: 1 month
Wolf Motor Function Test
The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.
Measured: 1 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Sep 201227 Feb 2017

First posted13 Aug 2012 (estimated)
Study start7 Sep 2012
Primary completion27 Feb 2017
Study completion27 Feb 2017

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 HemiparesisStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01662960
Sponsor's protocol ID: HN 4404
Other IDs: NIH R01 HD068565
Status last verified: Jun 2020
First submitted: 8 Aug 2012
Last updated: 30 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Telerehabilitation for Post-Stroke Hand Function
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Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
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All Hemiparesis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
ClinicalTrials.gov ID: NCT01662960
Acronym / sponsor ID: HN 4404
Conditions: Hemiparesis, Stroke
Keywords: stroke, hemiparesis, arm movement, sensory functioning
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Albert Einstein Healthcare NetworkUniversity, hospital or other
Study start: 7 Sep 2012 (actual)
Primary completion: 27 Feb 2017 (actual)
Study completion: 27 Feb 2017 (actual)
First posted: 13 Aug 2012 (estimated)
Results: Posted 13 May 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 the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mirror therapy	Experimental	Behavioral: Mirror therapy4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.
Divider therapy	Active comparator	Behavioral: Divider therapy4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.

Who may qualify

Ages: 21 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

6 months or more post-stroke
upper extremity Fugl-Meyer score between 10 and 50
no longer participating in upper-extremity physical or occupational therapy
sufficient comprehension ability to understand instructions

Key exclusion criteria (2 listed)

previous head trauma, psychiatric illness or chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g., haloperidol, dopaminergics)
dementia

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 therapyA home-based therapy involving mirrored visual feedback	Behavioural	Mirror therapy
Divider therapyA home-based therapy involving removed visual feedback.	Behavioural	Divider therapy

Primary outcome

Upper Extremity Fugl-Meyer
Time frame: Immediately after 1 month of treatment
This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.
Action Research Arm Test
Time frame: 1 month
The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.
Rivermead Assessment of Somatosensory Performance
Time frame: 1 month
This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.
Virtual-reality Assessment of Navigation
Time frame: 1 month
This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.

2 secondary outcomes

Stroke Impact Scale
Time frame: 1 month
Wolf Motor Function Test
Time frame: 1 months

Results and safety

Results posted to the registry on 13 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mirror Therapy: High Functioning	25	24
Mirror Therapy: Low Functioning	23	19
Divider Therapy: High Functioning	9	8
Divider Therapy: Low Functioning	15	15

Primary outcome: Upper Extremity Fugl-Meyer

Time frame: Immediately after 1 month of treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Mirror Therapy: High Functioning n = 25	Mirror Therapy: Low Functioning n = 23	Divider Therapy: High Functioning n = 9	Divider Therapy: Low Functioning n = 15
Value	43.8 (9.4)	21.4 (5.7)	42.8 (8.7)	21.5 (6.3)

Mirror Therapy: High Functioning vs Mirror Therapy: Low Functioning vs Divider Therapy: High Functioning vs Divider Therapy: Low Functioning: Slope: 2.2, p = .443, ANCOVA

Population analysed: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.

Primary outcome: Action Research Arm Test

Time frame: 1 month. Mean (Standard Deviation). Unit: score on a scale

Measure	Mirror Therapy: High Functioning n = 25	Mirror Therapy: Low Functioning n = 23	Divider Therapy: High Functioning n = 9	Divider Therapy: Low Functioning n = 15
Value	39.9 (11.8)	7.1 (5.0)	39.1 (13.6)	7.7 (5.6)

Mirror Therapy: High Functioning vs Mirror Therapy: Low Functioning vs Divider Therapy: High Functioning vs Divider Therapy: Low Functioning: Slope: 0.4, p = .80, ANCOVA

Population analysed: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.

Primary outcome: Rivermead Assessment of Somatosensory Performance

Time frame: 1 month. Mean (Standard Deviation). Unit: Proportion of items correct.

Measure	Mirror Therapy: High Functioning n = 25	Mirror Therapy: Low Functioning n = 23	Divider Therapy: High Functioning n = 9	Divider Therapy: Low Functioning n = 15
Value	0.76 (0.18)	0.52 (0.19)	0.79 (0.18)	0.60 (0.20)

Mirror Therapy: High Functioning vs Mirror Therapy: Low Functioning vs Divider Therapy: High Functioning vs Divider Therapy: Low Functioning: Slope: -.002, p = .93, ANCOVA

Population analysed: All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.

Primary outcome: Virtual-reality Assessment of Navigation

Time frame: 1 month

Population analysed: No participants were administered the test in the post-treatment phase because no participant exhibited a baseline 20% difference in item detection between the left and right side.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline screening until 3-month post-treatment follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mirror Therapy: High Functioning	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Mirror Therapy: Low Functioning	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Divider Therapy: High Functioning	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Divider Therapy: Low Functioning	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hemiparesis

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Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke
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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.

Steven Jax, Ph. D. principal investigator

Albert Einstein Healthcare Network

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 therapy and Divider therapy in people with Hemiparesis and Stroke, run by Albert Einstein Healthcare Network 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 2 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 30 Jun 2020. 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 13 May 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?

Upper Extremity Fugl-Meyer (time frame: Immediately after 1 month of treatment). 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 NCT01662960.

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 30 Jun 2020.