FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/082666 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Mirror Therapy vs HABIT Approach on mobility and function of single arm weakness due to stroke 
Scientific Title of Study   To study the effectiveness of Mirror Therapy vs HABIT Approach on motor function of hemiparetic upper limb in post-stroke subjects- A Randomized Control Trial 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajendra Kachhwaha 
Designation  Principal- Narayana Hrudayalaya College of Physiotherapy 
Affiliation  Narayana Hrudayalaya Institute Of Physiotherapy 
Address  Narayana Hrudayalaya Foundations, 258A Bommasandra Industrial Area Hosur Road, Bangalore 560099

Bangalore
KARNATAKA
560099
India 
Phone  9529822777  
Fax  8027832648  
Email  rajendra.kachhwaha@hrudayalayafoundation.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra Kachhwaha 
Designation  Principal- Narayana Hrudayalaya College of Physiotherapy 
Affiliation  Narayana Hrudayalaya Institute Of Physiotherapy 
Address  Narayana Hrudayalaya Foundations, 258A Bommasandra Industrial Area Hosur Road, Bangalore 560099

Bangalore
KARNATAKA
560099
India 
Phone  9529822777  
Fax  8027832648  
Email  rajendra.kachhwaha@hrudayalayafoundation.org  
 
Details of Contact Person
Public Query  
Name  Dr Rajendra Kachhwaha 
Designation  Principal- Narayana Hrudayalaya College of Physiotherapy 
Affiliation  Narayana Hrudayalaya Institute Of Physiotherapy 
Address  Narayana Hrudayalaya Foundations, 258A Bommasandra Industrial Area Hosur Road, Bangalore 560099

Bangalore
KARNATAKA
560099
India 
Phone  9529822777  
Fax  8027832648  
Email  rajendra.kachhwaha@hrudayalayafoundation.org  
 
Source of Monetary or Material Support  
Narayana Hrudayalaya Foundations 258/A Bommasandra Industrial Area Hosur Road, Bangalore 560099 
 
Primary Sponsor  
Name  Bipurna Ghimire 
Address  258/A, Health City, Bommasandra, Industrial Area, Anekal Taluk, Bangalore-560099 
Type of Sponsor  Other [self] 
 
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 
Bipurna Ghimire  Narayana Hrudayalaya hospital  258/A, Narayana Health City, Department of Physiotherapy, room no.19 Bommasandra Industrial Area, Anekal Taluk, Bangalore-560099
Bangalore
KARNATAKA 		 8088546831

bpurna.essentials98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Academic Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  HABIT APPROACH  HABIT program along with Conventional physical therapy twice a day per week for 30 minutes for 4 weeks. Task-oriented functional upper limb Hand-arm bilateral intensive training will be performed. Tasks will be carefully designed so the patient can select by its task motor function. Tasks based exercises given to the patients for 4 days per week for 4 weeks. Total Duration- 4 weeks 
Intervention  MIRROR THERAPY   Task-oriented functional upper limb Mirror therapy exercises will be focused for 20 minutes by imitating the reflection of the unaffected arm movement in the mirror. The patient should be able to move the hemiparetic arm in a manner identical to the unaffected arm reflected in the mirror under the direction of the therapist, who will assist patients in concentrating on their arm-movements. The exercises will be starting with arm in neutral position. The patient will be asked to repeat each movement 20 times per set for 3 sets, with a 2-minute break between the sets. Total Duration- 4 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects diagnosed with right or left upper extremity paresis or weakness,
Patient experienced stroke within 3-9 months,
Patient less than Grade3 spasticity on MAS,
Mini Mental State examination score 24 or more
Subjects with 10 degrees active wrist extension, 10 degrees active thumb abduction and 10 degrees active extension of any other two digits on affected hand. 
 
ExclusionCriteria 
Details  Post-stroke hemiparesis patients affected with cognitive and balance disturbances,
Patients who are not willing to participate,
patients suffering from any kind of musculoskeletal problems in affected upper extremity,
Patient having any perceptual and visual-spatial disorders,
Spasticity scoring more than 2 on MAS 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fugl-Meyer Assessment Scale (FMA-UE)   After 4 weeks of intervention application 
 
Secondary Outcome  
Outcome  TimePoints 
Action Research Arm Test (ARAT)  After 4 weeks of intervention applicable 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  


Aim:

The study aims to find effectiveness of Mirror Therapy compared with HABIT Approach along with conventional therapy improves the upper extremity motor function in patients with hemiparetic arm post stroke. With between-groups experimental design and random patient allocation to experimental and control groups. This study anticipates significant outcomes using Fugl-Meyer Assessment (FMA-UE) and Action Research Arm Test (ARAT).

Objectives:

Primary objective:

·         To compare the effects of Mirror Therapy and HABIT approach on hemiparetic arm motor functions in patient post-stroke.

Secondary objectives:

·         To evaluate the effectiveness of Mirror Therapy and HABIT approach in improving hemiparetic arm motor function in patient post-stroke.

·         To evaluate the effectiveness of Mirror Therapy and HABIT approach in improving muscle strength and endurance.

·         To evaluate the effectiveness of Mirror Therapy and HABIT approach in reducing pain and discomfort experienced by stroke.

 

   Hypothesis:

Null Hypothesis [H0]:

·         There will be no significant difference in effect of HABIT approach v/s Mirror Therapy on improving upper extremity motor function in patients with post-stroke hemiparesis.

Alternate Hypothesis [H1]:

·         There will be significant difference in effect of HABIT approach v/s Mirror Therapy on improving upper extremity motor function in patients with post-stroke hemiparesis.

 
Close