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

This study is currently recruiting participants.
Verified November 2012 by Christian Medical College and Hospital, Ludhiana, India
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: December 6, 2013
Last verified: November 2012
  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: Mirror therapy will be effective in the management of stroke patients with unilateral neglect as compared to limb activation technique.


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:
  • Unilateral neglect assessment tests [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Brunnstrom's stage of recovery Star cancellation test score Line bisection test score Catherine Bergego scale score


Secondary Outcome Measures:
  • Functional independence measure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Functional independence measure


Estimated Enrollment: 96
Study Start Date: April 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 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.
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.
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: After 48 hours 3. Patients willing to participate in the study 4. MRI/ CT scan showing parietal lobe and thalamic lesion

Exclusion Criteria:

  1. Stroke duration more than 1 yr
  2. Patients with cognitive deficits
  3. Uncooperative patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735877

Contacts
Contact: Dheeraj KV, MPT 919988048831 dheeraj_25@yahoo.com
Contact: Rajni Arora, MPT 7814406168 drrajniarora@gmail.com

Locations
India
Department of Neurology, CMC &H Recruiting
Ludhiana, Punjab, India, 141008
Contact: Jeyaraj D Pandian, DM    09915784750    jeyarajpandian@hotmail.com   
Principal Investigator: Jeyaraj D Pandian, DM         
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
Last Updated: December 6, 2013
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 April 17, 2014