| CTRI Number |
CTRI/2026/01/101971 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Extracorporeal Shock Wave Therapy on reducing
spasticity and improving hand function in patients with stroke: A
Repeated Measure Design |
|
Scientific Title of Study
|
Effectiveness of Extracorporeal Shock Wave Therapy on reducing spasticity and improving hand function in patients with stroke: A Repeated Measure Design. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kirti Zanwar |
| Designation |
Masters of Neurophysiotherapy student |
| Affiliation |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Department of Neurophysiotherapy OPD no 16 MIPT college MIMSR Campus Ambajogai Road Latur 413531
Latur
MAHARASHTRA
413531
India |
| Phone |
9511652084 |
| Fax |
|
| Email |
kirtizanwar22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Singh Mandade |
| Designation |
Professor of Neurophysiotherapy Department |
| Affiliation |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Department of Neurophysiotherapy OPD no 16 MIPT college MIMSR Campus Ambajogai Road Latur 413531
Department of Neurophysiotherapy OPD no 16 MIPT college MIMSR Campus Ambajogai Road Latur 413531
Latur
MAHARASHTRA
413531
India |
| Phone |
7972500020 |
| Fax |
|
| Email |
drneha9559@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Singh Mandade |
| Designation |
Professor of Neurophysiotherapy Department |
| Affiliation |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Department of Neurophysiotherapy OPD no 16 MIPT college MIMSR Campus Ambajogai Road Latur 413531
Department of Neurophysiotherapy OPD no 16 MIPT college MIMSR Campus Ambajogai Road Latur 413531
Latur
MAHARASHTRA
413531
India |
| Phone |
7972500020 |
| Fax |
|
| Email |
drneha9559@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy Latur |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Campus Ambajogai Road Latur |
| 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 Neha Singh Mandade |
Maharahstra Institute of Physiotherapy Latur 413531 |
Department of Neurophysiotherapy OPD no 16 Maharahstra Institute of Physiotherapy Latur MIMSR Campus Ambajogai road Latur 413531
Latur
MAHARASHTRA |
7972500020
drneha9559@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extracorporeal Shock Wave Therapy |
The application mode will be manual and on the middle of the muscle belly of FCR, FCU, Pronator teres and Palmaris longus using 1000 shots per muscle, freq. should be 5Hz. -After that assessments will be taken at the end of 2 and at the end of 4 weeks and the results will be compared between the baseline,
at the end of 2 & 4 weeks. The treatment duration will be 4weeks (once a day per week) along with the ongoing conventional PT |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 40 to 60 years of both genders
First episode of subacute stroke with unilateral involvement
Mini Mental Status Examination score more or equal to 24
Modified Ashworth Scale for upper extremity grade is less than or equal to 2
Voluntary Control Grading of hand should be minimally more or equal to GRADE III
Chedoke Arm and Hand Activity Inventory minimal 20 degrees of active wrist extension for functional grasp and release
Participants willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Any other neurological disorders such as MS TBI musculoskeletal disorders and blood disorders such as severe anaemia haemophilia thrombocytopenia.
Visual and cognitive impairments.
Patients who’ve received Botox injections or acupuncture within the past 6 months for upper extremity
Recent History that is within 3 months of myocardial infarction and coronary artery bypass
Sensory loss of affected upper extremity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Ashworth Scale
Chedoke Arm and Hand Activity Inventory version 7 |
All outcomes will be assessed at Baseline At the end of 2 weeks and at the end of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VCG hand
MMSE |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
02/02/2026 |
| 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="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
|
This study is Single Arm Repeated Measure Design The subjects will be selected based on the inclusion and exclusion criteria, and the study along with its methodology will be explained to them in detail. The outcome measures, including Modified Ashworth Scale [MAS] for assessing spasticity and Chedoke Arm and Hand Activity Inventory [CAHAI] for evaluating hand function in stroke patients, will be used. The intervention will be administered once a week for 4 weeks. Data will be collected at baseline, at the end of 2 weeks and at the end of 4th week. After all data is collected, statistical analysis will be conducted, and the results will be evaluated. The Intervention ESWT, application mode will be manual and on the middle of the muscle belly of FCR, FCU, Pronator teres and Palmaris longus using 1000 shots per muscle, freq. should be 5Hz. -After that assessments will be taken at the end of 2 and at the end of 4 weeks and the results will be compared between the baseline, at the end of 2 & 4 weeks. The treatment duration will be 4weeks (once a day per week) along with the ongoing conventional PT |