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CTRI Number  CTRI/2014/02/004401 [Registered on: 12/02/2014] Trial Registered Retrospectively
Last Modified On: 04/06/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Occupational Therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Exercise using a Mirror Box for paralytic patients 
Scientific Title of Study   Effectiveness of Mirror Therapy on motor recovery of upper extremity in chronic stroke  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kamal Narayan Arya 
Designation  Sr. Occupational Therapist 
Affiliation  Pt. Deendayal Upadhyaya Institute for the Physically Handicapped 
Address  Room No. 24, Department of Occupational Therapy, Pt. Deendayal Upadhyaya Institute for the Physically Handicapped,b 4 Vishnu Digamber Marg

Central
DELHI
110002
India 
Phone  9899897408  
Fax    
Email  kamalnarya@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kamal Narayan Arya 
Designation  Sr. Occupational Therapist 
Affiliation  Pt. Deendayal Upadhyaya Institute for the Physically Handicapped 
Address  Room No. 24, Department of Occupational Therapy, Pt. Deendayal Upadhyaya Institute for the Physically Handicapped,b 4 Vishnu Digamber Marg

Central
DELHI
110002
India 
Phone  9899897408  
Fax    
Email  kamalnarya@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Kamal Narayan Arya 
Designation  Sr. Occupational Therapist 
Affiliation  Pt. Deendayal Upadhyaya Institute for the Physically Handicapped 
Address  Room No. 24, Department of Occupational Therapy, Pt. Deendayal Upadhyaya Institute for the Physically Handicapped,b 4 Vishnu Digamber Marg

Central
DELHI
110002
India 
Phone  9899897408  
Fax    
Email  kamalnarya@yahoo.com  
 
Source of Monetary or Material Support  
Pt. Deendayal Upadhyaya Institute for the Physically Handicapped New Delhi-2 
 
Primary Sponsor  
Name  Pt Deendayal Upadhyaya Institute for the Physically Handicapped 
Address  Pt. Deendayal Upadhyaya Institute for the Physically Handicapped New Delhi-2 
Type of Sponsor  Other [Government Institution] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kamal Narayan Arya  Pt. Deendayal Institute for the Physically Handicapped  Room No. 23, Department of Occupational Therapy, Pt. Deendayal Upadhyaya Institute for the Physically Handicapped,b 4 Vishnu Digamber Marg
New Delhi
DELHI 		 9899897408

kamalnarya@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Room No. 24, Department of Occupational Therapy, Pt. Deendayal Upadhyaya Institute for the Physically Handicapped  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Post Stroke hemiparetic subjects,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Controlled Occupational therapy protocol  Controlled Occupational therapy protocol - based on brunnstrom movement therapy, NDT techniques using departmental activities / manual intervention 30 minutes 24 sessions over 6 weeks 
Intervention  Task Based Mirror Therapy  The subject is made to sit close to a table on which the mirror box is placed vertically at the mid sternum level. The less-affected upper limb is placed in front of the mirror to visualize the image while the affected limb was placed inside the mirror box. Subject could perceive the image of the less-affected limb as the affected limb. By observing the image of the less-affected upper extremity as a projection over the affected limb, an illusion is created 30 minutes 24 sessions over 6 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age: 40 to 70 year, both male & female, Hemiparesis (right / left), unilateral stroke (Ischemic / hemmorhagic), 6 to 24 months after stroke, Able to stand without support, Normal vision 
 
ExclusionCriteria 
Details  Receptive communication disorder, Wheelchair bound, Shoulder dislocation /musculoskeletal dysfunction, Severe cognitive / perceptual deficit 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Fugl-meyer assessment scale, Brunnstorm stages of motor recovery, Motor assessment scale   Baseline and post (after 6 weeks of the baseline assessment) 
 
Secondary Outcome  
Outcome  TimePoints 
Brunnstorm stages of motor recovery, BBS  Pre Post treatment (0 & 6th Week) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/10/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Arya KN, Pandian S. Effect of task-based mirror therapy on motor recovery of the upper extremity in chronic stroke patients:Apilot study. Topics In Stroke Rehabilitation. 2013;20:210 -217 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Background: Mirror therapy is a relatively new therapeutic intervention that uses the concept of visual illusion to enhance movement capability of the impaired limb. It has been found to be effective in enhancing the motor recovery of the hand and lower extremity. However, the effect of same has not been studied for the entire upper extremity recovery. This focuses the need of the present study.

Objectives

·        To study the effectiveness of mirror therapy in motor recovery of upper extremity.

·        To study the effectiveness of mirror therapy on motor recovery of hand.

·        To compare it with conventional therapy protocol.

Methodology

 Study Design: Randomozed controlled trial

Control group:   conventional therapy (Brunnstorm ,Bobath, Departmental activities)  for  the upper extremity of stroke

Experimental group: conventional therapy and mirror therapy for  the upper extremity of stroke

Place of study: Department of Occupational Therapy, PDUIPH

Inclusion criteria: Age: 40 to 70 year, both male & female, Hemiparesis (right / left), unilateral stroke (Ischemic / hemmorhagic), 6 to 24 months after stroke, Able to stand without support, Normal vision

Exclusion criteria: Receptive communication disorder, Wheelchair  bound, Shoulder dislocation /musculoskeletal dysfunction, Severe cognitive / perceptual deficit

Sample size:  40 post stroke patients (All the participants will be enrolled after obtaining signed informed consent form)

Sampling Method: Sample of convenience, Random assignment

Outcome measures: Fugl-meyer assessment scale, Brunnstorm stages of motor recovery, Motor assessment scale (All the measures paper-pencil performance based scale, standard guidelines are available from the literature)

Deliverable outcomes

The present study will lead to development of a novel rehabilitation protocol which would enhance motor recovery of the upper extremity in chronic stroke patients 
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