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

Hemispatial Neglect Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735877
• Other study ID #: MT2012
• Status: Completed
• Phase: Phase 3
• First received: November 26, 2012
• Last updated: May 24, 2014
• Start date: January 2011
• Est. completion date: August 2013

Study information

• Verified date: May 2014
• Source: Christian Medical College and Hospital, Ludhiana, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemispatial Neglect
• Perceptual Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Department of Neurology, CMC &H	Ludhiana	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Christian Medical College and Hospital, Ludhiana, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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 ?nd 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	No
Primary	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	No
Secondary	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 modi?ed 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	No
Secondary	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	No