| CTRI Number |
CTRI/2026/01/100057 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| 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
|
To study the effect of training of activities of everyday through video call in patients who are suffering from paralysis a long time |
|
Scientific Title of Study
|
Impact of Task-Oriented Training Delivered via Tele-Rehabilitation on Upper Limb Function in Chronic Stroke Survivors: A 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 |
Dr Svojas Pitale |
| Designation |
Student |
| Affiliation |
TMV Lokmanya Tilak College if Physiotherapy |
| Address |
TMV’s Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar,
Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
99303931638 |
| Fax |
|
| Email |
svojasp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Pimpale |
| Designation |
Professor & HOD |
| Affiliation |
TMV’s Lokmanya Tilak College of Physiotherapy |
| Address |
TMV’s Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar,
Kharghar, Navi Mumbai
TMV’s Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar,
Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9082194233 |
| Fax |
|
| Email |
dr.satishpimpale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satish Pimpale |
| Designation |
Professor & HOD |
| Affiliation |
TMV’s Lokmanya Tilak College of Physiotherapy |
| Address |
TMV’s Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar,
Kharghar, Navi Mumbai, India, 410210
TMV’s Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar,
Kharghar, Navi Mumbai , India,410210
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9082194233 |
| Fax |
|
| Email |
dr.satishpimpale@gmail.com |
|
|
Source of Monetary or Material Support
|
| TVs Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar,
Kharghar, Navi Mumbai, India , 410210 |
|
|
Primary Sponsor
|
| Name |
TMV Lokmanya Tilak College of Physiotherapy |
| Address |
TVs Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar,
Kharghar, Navi Mumbai, India, 410210 |
| Type of Sponsor |
Research institution |
|
|
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 Svojas Pitale |
TMV Lokmanya Tilak College of Physiotherapy |
TVs Lokmanya Tilak College of Physiotherapy, Third Floor, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar,
Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA |
9930931638
svojasp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee academic |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I678||Other specified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy |
Conventional Therapy:
Duration of the protocol : 30 minutes/ session for 5 days/week for 4 weeks
• Shoulder Shrugging 15 reps x 2sets
• Hand reachouts x 15 reps x 2 sets
• Elbow flexion/extension 15 reps x 2sets
• Forearm Pronation/Supination x 15 reps x 2 sets
• Wrist Flexion/Extension 15 reps x 2 sets
Grip exercise
• Lateral Prehension grip exercise – Key turn exs x 15 reps x 2 sets
• Ball squeeze exercise x 15 reps x 2sets
• Towel scrunch & squeeze x 15 reps x 2sets
• Finger Flexion/Extension of 1st
– 5th digit x 15 reps x 2 sets.
• Finger tapping of 1st
– 5th digit x 15 reps x 2 sets |
| Intervention |
Conventional therapy + Task Oriented therapy |
Conventional therapy:
Duration of the protocol : 30 minutes/ session for 5 days/week for 4 weeks
Shoulder Shrugging 15 reps x 2sets
Hand reachouts x 15 reps x 2 sets
Elbow flexion/extension 15 reps x 2sets
Forearm Pronation/Supination x 15 reps x 2 sets
Wrist Flexion/Extension 15 reps x 2 sets
Grip exercise
• Lateral Prehension grip exercise – Key turn exs x 15 reps x 2 sets
• Ball squeeze exercise x 15 reps x 2sets
• Towel scrunch & squeeze x 15 reps x 2sets
• Finger Flexion/Extension of 1st
– 5th digit x 15 reps x 2 sets.
• Finger tapping of 1st
– 5th digit x 15 reps x 2 sets
Task Oriented Therapy
Duration of the protocol : 30 minutes/ session for 5 days/week for 4 weeks
• Drinking water from a glass x 10reps , 2 sets
• Lifting a glass of water to a level of 90-degree shoulder flexion with an extended elbow
x 10 reps 2sets
• Stacking paper cups one over another x 10 reps 2 sets
• Wiping the table with a towel with the elbow extended x 10reps 2sets
• Grasping and releasing a tennis ball x 10 reps 2 sets
• Eating with a spoon x 10 reps x 2 sets |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Severe aphasia (with any medical disorders, Parkinson’s, Alzheimer’s),
Apraxia or visuospatial disorders,
Severe spasticity (grade: 3 and 4),
Musculoskeletal disorder to the upper limb,
Unstable medical conditions such as uncontrolled hypertension, convulsion, Unconscious
patient,
Uncooperative patients,
Severe cognitive impairment,
Visual & Hearing Impairment |
|
| ExclusionCriteria |
| Details |
Severe aphasia (with any medical disorders, Parkinson’s, Alzheimer’s),
Apraxia or visuospatial disorders,
Severe spasticity (grade: 3 and 4),
Musculoskeletal disorder to the upper limb,
Unstable medical conditions such as uncontrolled hypertension, convulsion, Unconscious
patient,
Uncooperative patients,
Severe cognitive impairment,
Visual & Hearing Impairment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
FUGL-MEYER ASSESSMENT ID:
UPPER EXTREMITY (FMA-UE) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="21"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/01/2026 |
| 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="1"
Months="5"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [svojasp@gmail.com].
- For how long will this data be available start date provided 26-12-2025 and end date provided 26-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - No
|
|
Brief Summary
|
My study is on comparing between tele rehabilitation and conventional form of rehabilitation of Upper extremity in Chronic stroke patients by doing Task Oriented training and using Fugl - Meyer Assesment for Upper Extremity as an outcome measure , the study will take place in the institution OPD and also through external OPD set up for conventional therapy and in the homes of the patients for tele rehabilitation . The groups will be divided into Group A conventional therapy and task oriented training & Group B only conventional therapy group |