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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
jeyarajpandian, Christian Medical College and Hospital, Ludhiana, India
ClinicalTrials.gov Identifier:
NCT01735877
First received: November 26, 2012
Last updated: May 24, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Hemispatial Neglect
Other: Mirror therapy
Other: Control group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Mirror Therapy in Stroke Patients With Unilateral Neglect - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Christian Medical College and Hospital, Ludhiana, India:

Primary Outcome Measures:
  • Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months [ Time Frame: Baseline, 1,3 and 6 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 1, 3 and 6 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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



Enrollment: 48
Study Start Date: January 2011
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  1. Stroke duration more than 1 yr
  2. Glasgow Coma Scale (GCS) of less than 7
  3. Uncooperative patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735877

Locations
India
Department of Neurology, CMC &H
Ludhiana, Punjab, India, 141008
Sponsors and Collaborators
Christian Medical College and Hospital, Ludhiana, India
Investigators
Principal Investigator: Jeyaraj Pandian, DM BFUHS
  More Information

No publications provided

Responsible Party: jeyarajpandian, Professor, Christian Medical College and Hospital, Ludhiana, India
ClinicalTrials.gov Identifier: NCT01735877     History of Changes
Other Study ID Numbers: MT2012
Study First Received: November 26, 2012
Results First Received: December 10, 2013
Last Updated: May 24, 2014
Health Authority: India: Institutional Review Board

Keywords provided by Christian Medical College and Hospital, Ludhiana, India:
Hemispatial neglect, Stroke

Additional relevant MeSH terms:
Stroke
Perceptual Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014