| CTRI Number |
CTRI/2025/08/093462 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of 4 Weeks of Task-Based Mirror Therapy vs Movement-Based Mirror Therapy on Leg Function and Balance in People with Stroke |
|
Scientific Title of Study
|
Effect of 4 weeks of Task-Based Mirror Therapy Versus Movement-Based Mirror Therapy
on Lower Limb Function and Balance in Individuals with Sub-acute Stroke: An
Experimental Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/A |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anushka Ajit Tambe PT |
| Designation |
Student of Masters of Physiotherapy in Neurophysiotherapy |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya College of Physiotherapy, Adult Neurorehabilitation OPD number
10 KJ Somaiya medical College Ayurvihar, Eastern Express Highway, Sion,
Mumbai, MAHARASHTRA, 400022.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9920011170 |
| Fax |
|
| Email |
anushka.tambe@somaiya.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anushka Ajit Tambe PT |
| Designation |
Student of Masters of Physiotherapy in Neurophysiotherapy |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya College of Physiotherapy, Adult Neurorehabilitation OPD number
10 KJ Somaiya medical College Ayurvihar, Eastern Express Highway, Sion,
Mumbai, MAHARASHTRA, 400022.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9920011170 |
| Fax |
|
| Email |
anushka.tambe@somaiya.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipali Suvarna PT |
| Designation |
Associate Professor |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya College of Physiotherapy, Adult Neuro Rehabilitation OPD Number 10, Ayurvihar, Eastern Express Highway, Sion Mumbai, Maharashtra
4 and 5, KJ Somaiya medical College Ayurvihar, Eastern Express Highway, Sion,
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8767039845 |
| Fax |
|
| Email |
dipali.suvarna@somaiya.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
K. J. Somaiya College of Physiotherapy |
| Address |
K J Somaiya College of Physiotherapy, Adult Neuro Rehabilitation
OPD number 10, Ayurvihar, Eastern Express Highway, Sion Mumbai
MAHARASHTRA 400022 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Anushka Ajit Tambe PT |
KJ Somaiya College of Physiotherapy, Ayurvihar |
Adult Neuro Rehabilitation OPD number 10, Department of Neuro physiotherapy
Mumbai
MAHARASHTRA |
09920011170
anushka.tambe@somaiya.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KJ Somaiya College of Physiotherapy |
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 |
| Comparator Agent |
Movement-Based Mirror Therapy (MMT) |
Participants will perform repetitive lower limb movements in front of a mirror, focusing on simulating the movement of the affected limb by performing identical movements with the unaffected limb while viewing its reflection. The exercises will target basic joint movements of the hip, knee, ankle, and toes, performed in a seated position. Each movement will be performed for 2 sets of 10 repetitions, with a minimum 30-second rest between movements. The intervention will be administered 3 days per week for 30–35 minutes per session, along with standard physiotherapy, for a total duration of 4 weeks. Progression will be achieved by gradually increasing movement range, speed, and repetitions according to individual performance and tolerance.
|
| Intervention |
Task-based Mirror Therapy (TMT) |
Participants will perform seven functional, goal-directed lower limb tasks in front of a mirror, including: (1) ball rolling forward and backward, (2) ball rolling sideways, (3) rocker board exercises, (4) pushing a pillow in forward, backward, and sideways directions, (5) picking up and releasing long pegs, (6) wiping the floor, and (7) placing the foot on markers on the floor. Each task will be performed for 2 sets of 10 repetitions, with a minimum 30-second rest between tasks. The intervention will be administered 3 days per week for 30–35 minutes per session, along with standard physiotherapy, for a total duration of 4 weeks. Progression will be achieved by gradually increasing task complexity, range of motion, and speed according to individual performance and tolerance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals aged 18 to 59 years
2. Experiencing a first-ever unilateral stroke
3. Currently in the sub-acute phase of stroke recovery, defined as between 8 days and 6 months.
4.Individuals demonstrating adequate cognitive function, as evidenced by a Mini-Mental State Examination (MMSE) score more than or equal to 24
5.Exhibiting a Voluntary Control Assessment (VCA) grade for ankle more than or equal to 3
6. Functional Ambulation Category grade more than or equal to 2
|
|
| ExclusionCriteria |
| Details |
1. Individuals with lower limb impairment caused by other diseases or musculoskeletal diseases.
2. Individuals diagnosed with psychiatric conditions
3. Individuals with diagnosed perceptual deficits and visual deficits (unilateral neglect, hemianopsia or apraxia)
4. Complete sensory loss (superficial and deep sensations) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Fugl-Meyer Assessment-Lower EXtremity
2.Bergs Balance Scale
3.Timed Up and Go Test |
1. Pre-treatment assessment
2. Post-treatment assessment at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
05/09/2025 |
| 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="3"
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
|
The study will be conducted after obtaining approval from the Institutional Ethics Committee (IEC), and all participants will provide written informed consent prior to enrollment. This experimental study will recruit 42 individuals with sub-acute stroke who meet the inclusion and exclusion criteria. Participants will be randomly allocated into two equal groups: Task-Based Mirror Therapy (TMT) group and Movement-Based Mirror Therapy (MMT) group. Outcome Measures:
Primary outcome measure: Fugl-Meyer Assessment for the Lower Extremity (FMA-LE) for motor function, Berg Balance Scale (BBS) for balance and Timed Up and Go (TUG) test for functional mobility. Procedure:
All participants will undergo pre-assessment for demographic data, medical history, and baseline values of FMA-LE, BBS, and TUG. TMT Group: Will perform functional, goal-directed lower limb tasks (ball rolling forward/backward and sideways, rocker board exercises, pushing a pillow in multiple directions, picking and releasing pegs, wiping the floor, and placing the foot on floor markers) in front of a mirror. Each task will be performed for 2 sets of 10 repetitions with short rest intervals, and the dosage will be progressively increased based on individual tolerance. MMT Group: Will perform repetitive, isolated lower limb movements (ankle dorsiflexion–plantarflexion, knee flexion–extension, hip abduction–adduction) in front of a mirror. Each movement will be performed for 2 sets of 10 repetitions with short rest intervals, and dosage will be progressively increased as tolerated. Both groups will receive their assigned mirror therapy intervention in addition to conventional physiotherapy, delivered three days per week. Each session will include 30–35 minutes of standard physiotherapy combined with the allocated mirror therapy, for a total intervention period of four weeks. Post-assessment:
At the end of the four-week intervention, FMA-LE, BBS, and TUG will be reassessed. Data Analysis:
Data will be analyzed using Statistical Package for the Social Sciences (SPSS) software. Descriptive statistics will be used to summarize demographic and baseline characteristics. Paired t-tests or Wilcoxon signed-rank tests will be used for within-group comparisons, and independent t-tests or Mann–Whitney U tests will be used for between-group comparisons, with the level of significance set at p < 0.05. |