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
Results First Received: December 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hemispatial Neglect
Interventions: Other: Mirror therapy
Other: Control group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: January 2011 to August 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Mirror Therapy 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

Group 2 will be given sham mirror therapy

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.


Participant Flow:   Overall Study
    Mirror Therapy     Control Group  
STARTED     27     21  
COMPLETED     26     21  
NOT COMPLETED     1     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mirror Therapy 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

Group 2 will be given sham mirror therapy

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.

Total Total of all reporting groups

Baseline Measures
    Mirror Therapy     Control Group     Total  
Number of Participants  
[units: participants]
  27     21     48  
Age  
[units: years]
Mean ± Standard Deviation
  63.15  ± 11.07     64.29  ± 12.02     63.65  ± 11.27  
Gender  
[units: participants]
     
Female     13     7     20  
Male     14     14     28  
Region of Enrollment  
[units: participants]
     
India     27     21     48  



  Outcome Measures
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1.  Primary:   Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months   [ Time Frame: Baseline, 1,3 and 6 months ]

2.  Primary:   Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months   [ Time Frame: Baseline, 1,3 and 6 months ]

3.  Primary:   Change From Baseline in Picture Identification Task at 1,3, and 6 Months   [ Time Frame: Baseline, 1,3 and 6 months ]

4.  Secondary:   Functional Independence Measure   [ Time Frame: Baseline, 1, 3 and 6 months ]

5.  Secondary:   Modified Rankin Scale (mRS)   [ Time Frame: Baseline, 1,3 and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Jeyaraj D Pandian
Organization: Christian Medical College & Hospital
phone: 09915784750
e-mail: jeyarajpandian@hotmail.com


No publications provided


Responsible Party: jeyarajpandian, 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