| CTRI Number |
CTRI/2025/04/085368 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| 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
|
Effect Of Myofascial Release With Tennis Ball On Spasticity And Motor Function Of Lower Limb In Patients With Chronic Stroke. A Randomized Control Trial |
|
Scientific Title of Study
|
Effect Of Myofascial Release With Tennis Ball On Spasticity And Motor Function Of Lower Limb In Patients With Chronic 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 |
Shreyas Talele |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe College of Physiotherapy Nagpur |
| Address |
Department of Neuroscience Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8208925703 |
| Fax |
|
| Email |
shreyastalele13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ira Indurkar |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe College of Physiotherapy Nagpur |
| Address |
Department of Neuroscience Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8806449657 |
| Fax |
|
| Email |
physioira@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreyas Talele |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe College of Physiotherapy Nagpur |
| Address |
Department of Neuroscience Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8208925703 |
| Fax |
|
| Email |
shreyastalele13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalinitai Meghe Hospital And Research Center, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of Physiotherapy |
| Address |
Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India |
| 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 Shreyas Talele |
Outpatient Department of Neurosciences Physiotherapy, Datta Meghe College of Physiotherapy |
Department of Neurosciences Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA |
8208925703
shreyastalele13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Ayurved, Physiotherapy, Nursing (APN) Colleges Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator Group |
This group will receive strengthening exercises, balance training and ambulation training for 4 weeks. |
| Intervention |
Interventional Group |
The patient will be given myofascial release for lower limb muscles including calf muscles, hamstrings in supine and sitting position for 4 weeks along with strengthening exercises, balance exercise, ambulation training as routine physiotherapy treatment. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of hemiplegia due to hemorrhagic or ischemic stroke.
Post stroke duration more than 6 months.
Ability to follow simple instructions.
Modified Ashworth scale score for the affected lower extremity greater than 1.
Ability to walk independently or with assistive devices. |
|
| ExclusionCriteria |
| Details |
Stroke involving more than one hemisphere.
Flaccid lower extremity.
Premorbid problems that would impede patterns
History of fractures, recent injuries. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Ashworth Scale
Timed Up and Go Test
Dynamic Gait Index
Fugl Meyer Assesment Scale |
Before and after Week 1
Before and after Week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
12/05/2025 |
| 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 Yet Recruiting |
| 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
|
Ethical Clearance will be taken from Institutional Ethical Committee. Consent will be taken and participants will be informed about the study purpose, objectives and methodology. Participants who satisfy the selection criteria will be recruited for the study. Conduct baseline assessment and general evaluation for all the participants. Participants will be randomly assigned to either Conventional group and Experimental group. The intervention for both the groups i.e. Conventional group and Experimental group will be given for 45 min per day for 5 days in a week. Post assessment will be taken after each week. Data analysis will be done. |