Hemispatial NeglectPhase 3MUSTNCT01735877

Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial

A Phase 3 study testing Mirror therapy in people with Hemispatial Neglect, run by Christian Medical College and Hospital, Ludhiana, India at 1 site in India.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hemispatial Neglect
What is being tested?: Mirror therapy
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteIndia
Study dates: Jan 2011to Aug 2013
Phase: Phase 3
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Stroke duration more than 1 yr
Glasgow Coma Scale (GCS) of less than 7
Uncooperative patients

Trial locations and contacts

1 site in 1 country.

India1 site

Department of Neurology, CMC &H
Ludhiana, Punjab, 141008

Other trials in India

About this study

Hemi spatial neglect, or the tendency to ignore stimuli originating in a portion of the environment contra lateral to a cerebral lesion, can be a major source of functional handicap after stroke. The currently available treatments for unilateral neglect are scanning training, visual cuing approaches, limb activation strategies, visual imagery, tactile stimulation, prisms and sustained attention training.Mirror therapy improves the hand function in sub-acute stroke.

Hypothesis: To evaluate the effectiveness of Mirror therapy in the management of stroke patients with unilateral neglect.

Read the detailed description

About 30 - 50% of stroke patients are left with considerable residual deficits. The post stroke disabilities are due to loss of locomotion and activities of daily living, cognition and communication skills.Hemispatial neglect has been reported in association with damage to several different cerebral structures in a large-scale distributed neurocognitive network.Mirror therapy improves the hand function in sub-acute stroke. It also helps in the recovery of neglect in stroke patients. But little consensus exists as to whether one treatment is more efficacious than others and many studies fail to document duration of treatment effects or generalization to daily activities. The aim of our study is to evaluate the effectiveness of limb activation with MT and limb activation strategy alone in the management of stroke patients with unilateral neglect and to make the patient functional in activities of daily living.

Conditions: Hemispatial Neglect
Being tested: Mirror therapy, Control group
Keywords: Hemispatial neglect, Stroke
Medical subject headings: Perceptual Disorders, Stroke

What participants receive

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

Mirror therapyOther
During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
Control groupOther
The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation.

Study groups in NCT01735877
Study group	Role	What they receive
Mirror therapy	Experimental	All eligible patients will be randomly allocated into 2 groups. Group 1 will be given Mirror therapy Receives: Other: Mirror therapy
Control group	Sham comparator	Group 2 will be given sham mirror therapy Receives: Other: Control group

What is being measured

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

Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months
The SCT consisted of a page containing 52 large stars, 10 short words and 13 letters, randomly positioned, with 56 small stars interspersed. Subjects were instructed to cross out (with a black pen) all the small stars across the page. The tester demonstrated by crossing out the two central stars. The cut off score to establish presence of unilateral visual neglect were: 51 or fewer stars cancelled for SCT.
Minimum score: 0 Maximum score: 54
Higher scores: better outcome
Measured: Baseline, 1,3 and 6 months
Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months
The Line Bisection Test (LBT) consisted of three horizontal black lines, 20 cm long, one to the right, one central and one to the left side of a sheet of white paper (21cms X 30 cms). The patients were asked to ﬁnd and mark the centre of each line in turn. Errors away from true midline were measured, with leftward errors being given a negative sign, rightward errors a positive sign.
We took an absolute value for the change in error. The values for baseline to 1 month were calculated by subtracting baseline values from 1 month values. Then, the mean change was calculated for baseline to 1 month. Similar method was followed for the calculation of mean change in baseline to 3 months and 6 months.
The patients responses were similar for the three lines that they marked hence we took the first line for the interpretation. None of the patients had extreme errors like missed marking at 3 and 6 months.
Measured: Baseline, 1,3 and 6 months
Change From Baseline in Picture Identification Task at 1,3, and 6 Months
PIT consisted of 10 pictures on A4 size paper and patients were asked to identify pictures. More the number of pictures identified, lesser was the neglect.
Measured: Baseline, 1,3 and 6 months

Secondary outcomes (2)

Functional Independence Measure
The FIM consists of 13 motor and 5 social-cognitive items, assessing self-care, sphincter management, transfer, locomotion, communication, social interaction and cognition.14 It uses a 7-level scale anchored by extreme rating of total dependence as 1 and complete independence as 7; the intermediate levels are: 6 modiﬁed independence, 5 supervision or set-up, 4 minimal contact assistance, 3 moderate assistance and 2 maximal assistance.
For the purpose of analysis we divided FIM into two categories ≤5 dependent, ≥6 independent.
Measured: Baseline, 1, 3 and 6 months
Modified Rankin Scale (mRS)
0 - No symptoms at all / 1 - No significant disability despite symptoms / 2 - Slight disability / 3 -Moderate disability, but able to walk without assistance / 4 - Moderate disability and unable to walk without assistance / 5 - Severe disability / 6 - death
0-2: Good outcome 3-6: Poor outcome
Measured: Baseline, 1,3 and 6 months

Timeline

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

Jan 2011Aug 2013

First posted28 Nov 2012 (estimated)
Study startJan 2011
Primary completionJul 2013
Study completionAug 2013

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hemispatial NeglectStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01735877
Sponsor's protocol ID: MT2012
Acronym: MUST
Status last verified: May 2014
First submitted: 26 Nov 2012
Last updated: 30 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Pandian JD, Arora R, Kaur P, Sharma D, Vishwambaran DK, Arima H. Mirror therapy in unilateral neglect after stroke (MUST trial): a randomized controlled trial. Neurology. 2014 Sep 9;83(11):1012-7. doi: 10.1212/WNL.0000000000000773. Epub 2014 Aug 8.
PubMed 25107877

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

Recruiting
Implementation of IVS3 for Upper Limb Motor Recovery
Neglect, Hemispatial, Stroke, Cardiovascular
Not yet recruitingObservational study
Motor Imaging, Neglect, and Upper Extremity Function in Stroke
Stroke, Neglect, Hemispatial
Not yet recruiting
Cerebellum and Neglect
Hemispatial Neglect, Visual Neglect
Recruiting
Strategy Training for Optimizing Attention for Individuals With Spatial Neglect
Stroke, Neglect, Hemispatial
Enrolling by invitation
Effectiveness of an Interactive Screen in the Rehabilitation of Neglect in Adults With Subacute Stroke: A Randomized Controlled Trial in Argentina.
Stroke, Neglect, Hemispatial

All Hemispatial Neglect trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT01735877
Acronym / sponsor ID: MUST / MT2012
Conditions: Hemispatial Neglect
Keywords: Hemispatial neglect, Stroke
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Christian Medical College and Hospital, Ludhiana, IndiaUniversity, hospital or other
Study start: Jan 2011
Primary completion: Jul 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 28 Nov 2012 (estimated)
Results: Posted 30 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypothesis: To evaluate the effectiveness of Mirror therapy in the management of stroke patients with unilateral neglect.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mirror therapy	Experimental	Other: Mirror therapyAll eligible patients will be randomly allocated into 2 groups. Group 1 will be given Mirror therapy
Control group	Sham comparator	Other: Control groupGroup 2 will be given sham mirror therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (3 listed)

Stroke duration more than 1 yr
Glasgow Coma Scale (GCS) of less than 7
Uncooperative patients

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 therapyDuring the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.	Other	Mirror therapy
Control groupThe control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation.	Other	Control group

Primary outcome

Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months
Time frame: Baseline, 1,3 and 6 months
The SCT consisted of a page containing 52 large stars, 10 short words and 13 letters, randomly positioned, with 56 small stars interspersed. Subjects were instructed to cross out (with a black pen) all the small stars across the page. The tester demonstrated by crossing out the two central stars. The cut off score to establish presence of unilateral visual neglect were: 51 or fewer stars cancelled for SCT. Minimum score: 0 Maximum score: 54 Higher scores: better outcome
Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months
Time frame: Baseline, 1,3 and 6 months
The Line Bisection Test (LBT) consisted of three horizontal black lines, 20 cm long, one to the right, one central and one to the left side of a sheet of white paper (21cms X 30 cms). The patients were asked to ﬁnd and mark the centre of each line in turn. Errors away from true midline were measured, with leftward errors being given a negative sign, rightward errors a positive sign. We took an absolute value for the change in error. The values for baseline to 1 month were calculated by subtracting baseline values from 1 month values. Then, the mean change was calculated for baseline to 1 month. Similar method was followed for the calculation of mean change in baseline to 3 months and 6 months. The patients responses were similar for the three lines that they marked hence we took the first line for the interpretation. None of the patients had extreme errors like missed marking at 3 and 6 months.
Change From Baseline in Picture Identification Task at 1,3, and 6 Months
Time frame: Baseline, 1,3 and 6 months
PIT consisted of 10 pictures on A4 size paper and patients were asked to identify pictures. More the number of pictures identified, lesser was the neglect.

2 secondary outcomes

Functional Independence Measure
Time frame: Baseline, 1, 3 and 6 months
Modified Rankin Scale (mRS)
Time frame: Baseline, 1,3 and 6 months

Results and safety

Results posted to the registry on 30 Jun 2014, 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	27	26
Control Group	21	21

Primary outcome: Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months

Time frame: Baseline, 1,3 and 6 months. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Mirror Therapy n = 26	Control Group n = 20
Baseline	17.88 (15.91 to 19.85)	18.20 (15.58 to 20.82)
Baseline to 1 month	20.03 (4.71)	5.90 (5.60)
Baseline to 3 month	31.76 (5.19)	9.2 (3.44)
Baseline to 6 month	34.88 (6.31)	11.60 (6.01)

Mirror Therapy vs Control Group: Mean Difference (Final Values): -0.43, p = 0.77, t-test, 2 sided
Mirror Therapy vs Control Group: Mean Difference (Final Values): 14.12 (95% CI 11.02 to 17.25), p <0.0001, ANCOVA
Mirror Therapy vs Control Group: Mean Difference (Final Values): 22.56 (95% CI 18.65 to 26.48), p <0.0001, ANCOVA

Population analysed: The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)

Primary outcome: Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months

Time frame: Baseline, 1,3 and 6 months. Mean (95% Confidence Interval). Unit: cms

Measure	Mirror Therapy n = 26	Control Group n = 20
Baseline	2.28 (-2.14 to 6.70)	0.45 (-4.87 to 5.77)
Baseline to 1 month	10.42 (7.99 to 12.84)	4.50 (1.73 to 7.26)
Baseline to 3 month	18.26 (14.37 to 22.16)	9.55 (5.10 to 13.99)
Baseline to 6 month	19.03 (15.10 to 22.97)	10.40 (5.91 to 14.88)

Mirror Therapy vs Control Group: Mean Difference (Final Values): 1.51, p = 0.64, t-test, 2 sided
Mirror Therapy vs Control Group: Mean Difference (Final Values): 5.92 (95% CI 2.24 to 9.60), p = 0.002, ANCOVA
Mirror Therapy vs Control Group: Mean Difference (Final Values): 8.71 (95% CI 2.80 to 14.63), p = 0.005, ANCOVA

Primary outcome: Change From Baseline in Picture Identification Task at 1,3, and 6 Months

Time frame: Baseline, 1,3 and 6 months. Mean (95% Confidence Interval). Unit: pictures

Measure	Mirror Therapy n = 26	Control Group n = 20
Baseline	4.84 (4.64 to 5.04)	4.20 (3.71 to 4.69)
Baseline to 1 month	4.88 (4.38 to 5.37)	1.2 (0.64 to 1.75)
Baseline to 3 month	5.16 (4.62 to 5.69)	1.75 (1.15 to 2.34)
Baseline to 6 month	5.16 (4.62 to 5.69)	1.95 (1.34 to 2.55)

Mirror Therapy vs Control Group: Mean Difference (Final Values): 0.64, p = 0.99, t-test, 2 sided
Mirror Therapy vs Control Group: Mean Difference (Final Values): 3.68 (95% CI 2.93 to 4.42), p <0.0001, ANCOVA
Mirror Therapy vs Control Group: Mean Difference (Final Values): 3.41 (95% CI 2.61 to 4.21), p <0.0001, ANCOVA

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mirror Therapy	0 of 27 (0%)	0 of 27 (0%)	Not reported
Control Group	0 of 21 (0%)	0 of 21 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25107877Pandian JD, Arora R, Kaur P, Sharma D, Vishwambaran DK, Arima H. Mirror therapy in unilateral neglect after stroke (MUST trial): a randomized controlled trial. Neurology. 2014 Sep 9;83(11):1012-7. doi: 10.1212/WNL.0000000000000773. Epub 2014 Aug 8.

Related trials for Hemispatial Neglect

Recruiting
Implementation of IVS3 for Upper Limb Motor Recovery
Neglect, Hemispatial, Stroke, Cardiovascular
Not yet recruitingObservational study
Motor Imaging, Neglect, and Upper Extremity Function in Stroke
Stroke, Neglect, Hemispatial
Not yet recruiting
Cerebellum and Neglect
Hemispatial Neglect, Visual Neglect
Recruiting
Strategy Training for Optimizing Attention for Individuals With Spatial Neglect
Stroke, Neglect, Hemispatial
Enrolling by invitation
Effectiveness of an Interactive Screen in the Rehabilitation of Neglect in Adults With Subacute Stroke: A Randomized Controlled Trial in Argentina.
Stroke, Neglect, Hemispatial

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.

Jeyaraj Pandian, DM principal investigator

BFUHS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirror therapy in people with Hemispatial Neglect, run by Christian Medical College and Hospital, Ludhiana, India at 1 site in India.

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 0 inclusion and 3 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 2014. 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 India. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2014). 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?

Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months (time frame: Baseline, 1,3 and 6 months). The study lists 3 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 NCT01735877, 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 30 Jun 2014.