Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial
MUST
1 other identifier
interventional
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 26, 2012
CompletedFirst Posted
Study publicly available on registry
November 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
June 30, 2014
CompletedJune 30, 2014
May 1, 2014
2.5 years
November 26, 2012
December 10, 2013
May 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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.
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.
Baseline, 1,3 and 6 months
Secondary Outcomes (2)
Functional Independence Measure
Baseline, 1, 3 and 6 months
Modified Rankin Scale (mRS)
Baseline, 1,3 and 6 months
Study Arms (2)
Mirror therapy
EXPERIMENTALAll eligible patients will be randomly allocated into 2 groups. Group 1 will be given Mirror therapy
Control group
SHAM COMPARATORGroup 2 will be given sham mirror therapy
Interventions
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.
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.
Eligibility Criteria
You may not qualify if:
- Stroke duration more than 1 yr
- Glasgow Coma Scale (GCS) of less than 7
- Uncooperative patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurology, CMC &H
Ludhiana, Punjab, 141008, India
Related Publications (1)
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.
PMID: 25107877DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Jeyaraj D Pandian
- Organization
- Christian Medical College & Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Jeyaraj Pandian, DM
BFUHS
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 26, 2012
First Posted
November 28, 2012
Study Start
January 1, 2011
Primary Completion
July 1, 2013
Study Completion
August 1, 2013
Last Updated
June 30, 2014
Results First Posted
June 30, 2014
Record last verified: 2014-05