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

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.

Study Overview

• Status: Completed
• Conditions: Hemispatial Neglect
• Intervention / Treatment: Other: Mirror therapy; Other: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Baseline, 1,3 and 6 months

Collaborators and Investigators

• Sponsor: Christian Medical College and Hospital, Ludhiana, India
• Investigators: Principal Investigator: Jeyaraj Pandian, DM, BFUHS

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: November 26, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 28, 2012

Study Record Updates

• Last Update Posted (Estimate): June 30, 2014
• Last Update Submitted That Met QC Criteria: May 24, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Hemispatial neglect, Stroke
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders
• Other Study ID Numbers: MT2012