| CTRI Number |
CTRI/2024/06/068308 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Immediate effects of Movement Illusions Induced by Visual Stimulation and Mirror Therapy on Hand functions in patients with stroke |
|
Scientific Title of Study
|
Comparison between immediate effects of Kinesthetic illusions induced by visual stimulations (KINVIS) and Mirror therapy on hand functions in individuals with stroke. |
| 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 Lakshmiprabha Rangarajan |
| Designation |
Assistant Professor |
| Affiliation |
P.T. School and Centre Seth GSMC and KEMH |
| Address |
P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, Room number 3, OC Bldg, E Borges road, opp to TATA Hospital, Parel Mumbai
MAHARASHTRA 400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9870487879 |
| Fax |
|
| Email |
laps2204@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmiprabha Rangarajan |
| Designation |
Assistant Professor |
| Affiliation |
P.T. School and Centre Seth GSMC and KEMH |
| Address |
P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, room number 3, OC Bldg, E Borges road, opp to TATA Hospital, Parel Mumbai
MAHARASHTRA 400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9870487879 |
| Fax |
|
| Email |
laps2204@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rutuja Sathe |
| Designation |
Post graduate Neurophysiotherapy student |
| Affiliation |
P.T. School and Centre Seth GSMC and KEMH |
| Address |
P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, room number 3, OC Bldg, E Borges road, opp to TATA Hospital, Parel Mumbai
MAHARASHTRA 400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7718052283 |
| Fax |
|
| Email |
rutujasathe99@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, Room number 3, OC Bldg, E Borges road, opp to TATA Hospital, Parel Mumbai
MAHARASHTRA 400012
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 |
| Dr Lakhmiprabha Rangarajan |
P.T. School and Centre Seth GSMC and KEMH |
Room 3 Adult Neuro OPD, P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department OC Bldg, E Borges road, opp to TATA Hospital, Parel Mumbai
MAHARASHTRA 400012
India
Mumbai
MAHARASHTRA |
9870487879
laps2204@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee 3 of Seth GSMC and KEMH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesthetic Illusions Induced by Visual Stimulations (KINVIS) |
The intervention of 20 minutes, includes the subject seated comfortably on a chair looking at a mirrored video of a non paretic side in a video-displaying device placed over paretic hand. The video displaying following activities; wrist ROM exercises (flexion, extension, radial and ulnar deviation, pronation, supination) and finger ROM exercises (flexion, extension, opposition), with 10 repetitions each. Gross dexterity activities involve holding and releasing objects like a bottle, ball, cube, and performing pegboard activities, while fine motor activities include holding and releasing a key, paper, and spoon, each done for 10 repetitions. To maintain attention, a 2-minute rest period is provided between ROM exercises, gross dexterity activities, and fine motor activities.
Intervention time for KINVIS is 20 minutes and for conventional treatment is 40 minutes. Therefore, total intervention time is 60-75 minutes. |
| Comparator Agent |
Mirror Therapy |
20 minutes intervention with a subject seated comfortably in a chair with paretic arm inside a mirror box. The subject is made to look at the mirror impression of the activities of non-paretic hand performing following movements; wrist ROM exercises (flexion, extension, radial and ulnar deviation, pronation, supination) and finger ROM exercises (flexion, extension, opposition), with 10 repetitions each. Gross dexterity activities involve holding and releasing objects like a bottle, ball, cube, and performing pegboard activities, while fine motor activities include holding and releasing a key, paper, and spoon, each done for 10 repetitions. To maintain attention, a 2-minute rest period is provided between ROM exercises, gross dexterity activities, and fine motor activities.
Intervention time for Mirror therapy is 20 minutes and for conventional treatment is 40 minutes. Therefore, total intervention time is 60-75 minutes. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed with sub-acute (1 week to 6 months) and chronic (6 months or more)
unilateral stroke
Bruunstorm hand functions grades from 2 to 5
Able to follow simple verbal commands |
|
| ExclusionCriteria |
| Details |
Any acute cardiovascular, respiratory and musculoskeletal impairment
Uncontrolled Diabetes and Hypertension
Uncorrected Visual and Auditory impairments
Any other neurological impairments other than Stroke
Any Psychiatric illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Jebson hand function test
Visual analogue scale |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
15/06/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Neurological rehabilitation is an important component in effectively addressing stroke-related challenges. It seeks to maximize motor functions, enhance quality of life, and promote independency. The Kinesthetic Illusions Induced by Visual Stimulations (KINVIS) protocol explores a psychological phenomenon where individuals perceive movement or desire to move a body part while watching a mirrored video of the same body part. This newer technique, effective in stroke rehabilitation, involves viewing a mirrored video of a non- paretic extremity. Subjects diagnosed with sub-acute or chronic unilateral stroke, aged 20-80, meeting specific criteria, will undergo a crossover study with counterbalancing in a tertiary care hospital’s physiotherapy OPD. The study aims to provide insights into more effective/feasible stroke rehabilitation approaches. Half of the number of total participants will undergo KINVIS intervention in their 1st session and Mirror therapy in 2nd session along with one week of wash out period between 2 sessions. Similarly, other half of the number of total participants will undergo Mirror therapy in their 1st session and KINVIS in 2nd sessions with one week wash out period between the 2 sessions. Pre and post assessment of hand function, every single session of KINVIS and Mirror therapy will be by Modified Jebson Test (MJT) for both interventions and post every session of both interventions measurement of Sense of agency will be done by Visual analogue scale. For normally distributed data of MJT, paired T-tests compare pre and post interventions, and unpaired T tests will be used to compare two interventions. For the not normally distributed data, Mann- Whitney U test will be used to compare pre and post interventions, and Wilcoxon signed-rank test for the comparison between the two interventions. If the data is normally distributed, an unpaired T-test compares the Sense of Agency between the two interventions; if it is not normally distributed Wilcoxon signed-rank test is used. |