| CTRI Number |
CTRI/2026/01/100085 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
5 weeks Effect of myofacial release and stretching on wrist flexor spasticity in stroke patients |
|
Scientific Title of Study
|
Effectiveness of Myofascial release and Maintained stretch on wrist flexors spasticity by assessing H reflex in Patients with Stroke- an Experimental 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 |
Maheshwari Harishchandre |
| Designation |
Professor |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
College of Physiotherapy Neurophysiotherapy
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9130054937 |
| Fax |
|
| Email |
maheshwariharishchandre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudhir Tungikar |
| Designation |
Professor and Head |
| Affiliation |
Dr Balasaheb Vikhe Patil Rural Medical College Loni |
| Address |
Department of Medicine Rural Medical College Loni
Rural Medical College Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9405679329 |
| Fax |
|
| Email |
sudhirtungikar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maheshwari Harishchandre |
| Designation |
Professor |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
College of Physiotherapy Neurophysiotherapy
MAHARASHTRA
414111
India |
| Phone |
9130054937 |
| Fax |
|
| Email |
maheshwariharishchandre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vikhe Patil Memorial Hospital Physiotherapy OPD Vadgaon Gupta
Pincode 414111
Maharashtra
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 |
| Maheshwari |
Vikhe Patil Memorial Hospital |
Physiotherapy OPD Neuro OPD room no 102
Ahmadnagar
MAHARASHTRA |
9130054937
maheshwariharishchandre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Myofascial release |
5 days week 1session per day |
| Intervention |
Myofascial release teachniques and sretching |
5 weeks MFR and 5 weeks Stretching 5days per week 1 session per day |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
First Onset Diagnosed Stroke Patients
Subacute and Chronic Stage Both Gender
20to55years stroke participants
Spasticitygrades1to 3
|
|
| ExclusionCriteria |
| Details |
• HemiplegicstrokeParticipantswhohaveanyothermusculoskeletal(recentfracture,handdeformity)cardiacvascularrelatedconditions(uncontrolledhypertensionmyocardialinfarction) |
|
|
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 |
| Modified tardieu scale |
5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| H reflex |
5 weeks |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2026 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Stroke is the leading cause of the death in India. spasticity is a common complication observed after stroke. Wrist flexor spasticity is limits the patients functional capacity. patients facing difficulties or inability to do the daily activities like bathing brushing kitchen work dressing undressing eating combing which is important in day to day life. Modifed tardieu scale and ah reflex are the measurement tools which helps to measure the spasticity in muscles. conventionally there are so many techniques are used to relieve the spasticity but Myofacial release techniques and stretching are mainly used to reduce the spasticity and helps to improve the hand function. |