Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial (MUST)
Primary Purpose
Hemispatial Neglect
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Mirror therapy
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Hemispatial Neglect focused on measuring Hemispatial neglect, Stroke
Eligibility Criteria
Inclusion Criteria: 1.All stroke patients with parietal lobe and thalamic lesions 2. Stroke duration: within 48 hours 3. Patients willing to participate in the study 4. MRI/ CT scan showing parietal lobe and thalamic lesion 5. Patients with upper limb weakness
Exclusion Criteria:
- Stroke duration more than 1 yr
- Glasgow Coma Scale (GCS) of less than 7
- Uncooperative patients
Sites / Locations
- Department of Neurology, CMC &H
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Mirror therapy
Control group
Arm Description
All eligible patients will be randomly allocated into 2 groups. Group 1 will be given Mirror therapy
Group 2 will be given sham mirror therapy
Outcomes
Primary Outcome Measures
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
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.
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.
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT01735877
First Posted
November 26, 2012
Last Updated
May 24, 2014
Sponsor
Christian Medical College and Hospital, Ludhiana, India
1. Study Identification
Unique Protocol Identification Number
NCT01735877
Brief Title
Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial
Acronym
MUST
Official Title
Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Christian Medical College and Hospital, Ludhiana, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemispatial Neglect
Keywords
Hemispatial neglect, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mirror therapy
Arm Type
Experimental
Arm Description
All eligible patients will be randomly allocated into 2 groups. Group 1 will be given Mirror therapy
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Group 2 will be given sham mirror therapy
Intervention Type
Other
Intervention Name(s)
Mirror therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months
Description
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
Time Frame
Baseline, 1,3 and 6 months
Title
Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months
Description
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.
Time Frame
Baseline, 1,3 and 6 months
Title
Change From Baseline in Picture Identification Task at 1,3, and 6 Months
Description
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.
Time Frame
Baseline, 1,3 and 6 months
Secondary Outcome Measure Information:
Title
Functional Independence Measure
Description
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.
Time Frame
Baseline, 1, 3 and 6 months
Title
Modified Rankin Scale (mRS)
Description
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
Time Frame
Baseline, 1,3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.All stroke patients with parietal lobe and thalamic lesions 2. Stroke duration: within 48 hours 3. Patients willing to participate in the study 4. MRI/ CT scan showing parietal lobe and thalamic lesion 5. Patients with upper limb weakness
Exclusion Criteria:
Stroke duration more than 1 yr
Glasgow Coma Scale (GCS) of less than 7
Uncooperative patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeyaraj Pandian, DM
Organizational Affiliation
BFUHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, CMC &H
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
25107877
Citation
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.
Results Reference
derived
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Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial
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