Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial (MUST)
|ClinicalTrials.gov Identifier: NCT01735877|
Recruitment Status : Completed
First Posted : November 28, 2012
Results First Posted : June 30, 2014
Last Update Posted : June 30, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemispatial Neglect||Other: Mirror therapy Other: Control group||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial|
|Study Start Date :||January 2011|
|Primary Completion Date :||July 2013|
|Study Completion Date :||August 2013|
Experimental: Mirror therapy
All eligible patients will be randomly allocated into 2 groups. Group 1 will be given Mirror therapy
Other: Mirror therapy
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.
Sham Comparator: Control group
Group 2 will be given sham mirror therapy
Other: Control group
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.
- 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.
- Functional Independence Measure [ Time Frame: Baseline, 1, 3 and 6 months ]
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) [ Time Frame: Baseline, 1,3 and 6 months ]
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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735877
|Department of Neurology, CMC &H|
|Ludhiana, Punjab, India, 141008|
|Principal Investigator:||Jeyaraj Pandian, DM||BFUHS|