| CTRI Number |
CTRI/2026/03/105654 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can Mirror Therapy Improve Leg Recovery and Balance After Stroke? A Pilot Study |
|
Scientific Title of Study
|
Efficacy of mirror therapy versus standard physiotherapy on lower extremity function, balance and ICU mobilization in acute stroke - A pilot randomized controlled 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 |
Alexander Abraham |
| Designation |
Researcher |
| Affiliation |
Gitam school of physiotherapy |
| Address |
GSPT 4th floor, GIMSR building
visakhapatnam
ANDHRA PRADESH
530045
INDIA
GSPT, 4th floor, GIMSR building
visakhapatnam
ANDHRA PRADESH
530045
INDIA
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
7989379363 |
| Fax |
|
| Email |
swathikomara0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srinadh katragadda |
| Designation |
Assistant professor |
| Affiliation |
Gitam school of physiotherapy |
| Address |
GSPT, 4TH floor, GIMSR buildng
visakhapatnam
ANDHRA PRADESH
530045
INDIA
GSPT, 4TH floor, GIMSR buildng
visakhapatnam
ANDHRA PRADESH
530045
INDIA
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9618552526 |
| Fax |
|
| Email |
skatradg@gitam.edu |
|
Details of Contact Person
Public Query
|
| Name |
Alexander Abraham |
| Designation |
Researcher |
| Affiliation |
Gitam school of physiotherapy |
| Address |
GSPT, 4TH floor, GIMSR buildng
visakhapatnam
ANDHRA PRADESH
530045
INDIA
GSPT, 4TH floor, GIMSR buildng
visakhapatnam
ANDHRA PRADESH
530045
INDIA
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
7989379363 |
| Fax |
|
| Email |
swathikomara0@gmail.com |
|
|
Source of Monetary or Material Support
|
| GIMSR hospital, visakhapatnam
ANDHRA PRADESH , 530045 |
|
|
Primary Sponsor
|
| Name |
Alexander Abraham |
| Address |
4th floor,Gitam school of physiotherapy,GIMSR college building,GIMSR campus,Rushikonda,Visakhapatnam-530045 |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Alexander abraham |
GITAM UNIVERSITY |
4th floor,Gitam school of physiotherapy,GIMSR college building,GIMSR campus,Rushikonda,Visakhapatnam-530045
Visakhapatnam
ANDHRA PRADESH |
7989379363
swathikomara0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GIMSR ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mirror therapy |
Mirror therapy for lower extremity in acute stroke patients for 2 weeks |
| Comparator Agent |
Standard physiotherapy intervention |
Standard physiotherapy intervention in control group for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Consenting men and women (25–65) with first-time, stable, oriented, and diagnosed acute ischemic stroke. |
|
| ExclusionCriteria |
| Details |
Bilateral/recurrent stroke, limb fractures, and significant cognitive, perceptual, vestibular, or visual impairments |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fugl-Meyer Assessment lower extremity (FMA-LE) |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Berg balance, ICU mobility scale |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
20/03/2026 |
| 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
|
This study is a pilot Randomized trail on acute stroke patients our study title is “Efficacy of mirror therapy versus standard physiotherapy on lower extremity function, balance and ICU mobilization in acute stroke – A pilot randomized controlled trial” where we started the approval from Ethics Committee (IEC) as per the ICMR Guidelines. The recruitment of participants will be based on the inclusion criteria. Informed consent will be obtained from all participants after a clear and comprehensive explanation of the study procedures, only those who provide a signed informed consent form will be enrolled. Participants will be randomly assigned to either a control group or a mirror group using single blind method. This will be accomplished by assigning participants a number (1-12). The case group will receive standardized therapy (patient-tailored) following a detailed initial assessment. The mirror group will receive the same standardized therapy with the addition of mirror therapy for 30 mins including rest periods. During the mirror therapy, a rectangular mirror will be positioned vertically or horizontally between the lower limbs, depending on the desired movement. Where the affected leg is faced towards non-reflecting side and unaffected leg towards reflecting side and patient is asked to perform movements. The outcome will be administered after completing the study duration. The data will be collected and stored for analysis. |