| CTRI Number |
CTRI/2025/03/083400 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Compare the effect of movement imagination treatment versus mirror treatment on unilateral negelct in subacute stroke patients with left side hemiparesis - A Comparative Study |
|
Scientific Title of Study
|
Comparison between motor imagery and mirror therapy on unilateral negelct in subacute stroke patients with left side hemiparesis - A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPrathmesh Pradeep Joshi |
| Designation |
MPT student |
| Affiliation |
Dr.Ulhas Patil college of Physiotherapy,Jalgaon |
| Address |
Physiotherapy OPD, Room no 207
Jalgaon
MAHARASHTRA
425001
India |
| Phone |
09604093691 |
| Fax |
|
| Email |
prathmeshjoshi1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrChitra Mridha |
| Designation |
Professor |
| Affiliation |
Dr.Ulhas Patil college of Physiotherapy,Jalgaon |
| Address |
Physiotherapy OPD, Room no 207
Jalgaon
MAHARASHTRA
425001
India |
| Phone |
9881929503 |
| Fax |
|
| Email |
chitun.kirtaniya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prathmesh Joshi |
| Designation |
MPT student |
| Affiliation |
Dr.Ulhas Patil college of Physiotherapy,Jalgaon |
| Address |
Physiotherapy OPD, Room no 207
MAHARASHTRA
425001
India |
| Phone |
09604093691 |
| Fax |
|
| Email |
prathmeshjoshi1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Ulhas Patil college of physiotherapy,Jalgaon
NH 06, Gat No. 57 1, Khirdi Shivar,Tal And Dist Jalgaon
Jalgaon
MAHARASHTRA
425001
India |
|
|
Primary Sponsor
|
| Name |
DrPrathmesh Pradeep Joshi |
| Address |
NH 06, Gat No. 57 1, Khirdi Shivar,Tal And Dist Jalgaon
Jalgaon 425001,MAHARASHTRA,India
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrPrathmesh Joshi |
Dr.Ulhas Patil College Of Physiotherapy |
OPD no 207,
Physiotherapy OPD
,Jalgaon
Jalgaon
MAHARASHTRA
Jalgaon
MAHARASHTRA |
09604093691
prathmeshjoshi1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Dr. ulhas patil college of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.motor imagery |
selected tasks will carry out for a total of 25 min and 1 will perform
for 4 min with a rest time of 1 min. the sessions are 5 days/week for 4 week. |
| Comparator Agent |
2.Mirror therapy |
All tasks will repeat 3 times, with 1 min rest period. A session is for 25
min and 5 days / week for 4 week. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) age above 45 years and below 60 years, both male and female
subjects,
2) more than 1 month and less than 6 months after stroke onset with
left side hemiparesis.
3) patient with an MMSE score of 24 or higher
4) test for neglect in a clinical setting was the line bisection test (LBT).
The LBT was based on patients who deviated 6mm to the right from the center |
|
| ExclusionCriteria |
| Details |
1) A patient with a severely impaired sitting posture, unable to sit on a chair with a back and armrests
2) Patients with limited neck range of motion due to orthopedic disorders
3) patients who experienced problems such as headache and dizziness while using the screen
4) Patients with severely impaired vision, unable to recognize object. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Star cancellation test |
At baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
26/03/2025 |
| 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="1"
Months="0"
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-. To study the effect motor imagery vs mirror therapy on unilateral neglect in subacute stroke patient with left side hemiparesis. OBJECTIVE- 1.To find of the effect of motor imagery on unilateral neglect in subacute stroke patient with left side hemiparesis. 2.To find of the effect of mirror therapy on unilateral neglect in subacute stroke patient left side hemiparesis. 3.To compare the effect of motor imagery and mirror therapy on unilateral neglect in subacute stroke patient left side hemiparesis.
PROCEDURE- Ethical clearance will be obtained from the institutional ethical committee. The purpose & procedure of the study will be explained to participant. A written consent will be obtained. Subjects will be screened according to inclusion & exclusion criteria. pre intervention outcome measures will take on 1stday of intervention. Group A will receive motor imagery and group B will receive mirror therapy and post intervention outcome measures will take after 4 weeks on last day of intervention.
INTERVENTION PROTOCOL: - Group A- MOTOR IMAGERY • Among the basic daily life activities tasks, five purposeful and meaningful activities are selected. • These 5 tasks are as follows: (1) using spoon, (2) using a pencil, (3) hand washing, (4) using a mobile phone (5) drinking with a water bottle • The 5 selected tasks will carry out for a total of 25 min and 1 will perform for 4 min with a rest time of 1 min. • These tasks videos will perform by the therapist and it will upload in laptop. • Patient will perform using a 15-inch laptop placed on a 70 cm high table in an independent space in a quiet environment. • The Patient will ask to watch the video and imagine that they are doing task with affected hand without doing any movement. • the sessions are 5 days/week for 4 week.
Group B- MIRROR THERAPY • Regarding the mirror therapy, patients will sit near a table on which a mirror box (35 *35 cm) will placed vertically. patient who will confirmed that the hand on the unaffected side is reflected in the mirror and affected hand is in the mirror box. • Therapist will instruct to patient to move the hand on the unaffected side (grasp/release the hand and supinate/pronate the forearm and wrist flexion and extension). • Then therapist will instruct to patient to Try visualize illusion provides normal motion in the affected hand and try to emulate that movement with the affected hand. • All 3 tasks will repeat 3 times, with 1 min rest period. A, session is for 25 min and 5 days / week for 4 week. |