| CTRI Number |
CTRI/2025/07/090251 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of electromyography biofeedback therapy with Scapular muscle activation exercises vs only Scapular muscle activation exercises on malalignment of Scapula in stroke survivors : A pilot study
|
|
Scientific Title of Study
|
Effect of EMG biofeedback therapy combined with Scapular Stabilization exercises versus only Scapular Stabilization exercises on Scapular Dyskinesis in subacute and chronic stroke survivors : A pilot 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 |
Dr Snehal Joshi PT |
| Designation |
Principal and HOD Neurophysiotherapy department |
| Affiliation |
D.E.S Brijlal Jindal college of Physiotherapy |
| Address |
Neurophysiotherapy Department, DES Brijlal Jindal college of Physiotherapy, Fergusson College Campus, Shivajinagar, Pune- 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
9225340940 |
| Fax |
|
| Email |
snehal.joshi@despune.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhura Joshi PT |
| Designation |
Post graduate student |
| Affiliation |
D.E.S. Brijlal Jindal college of Physiotherapy |
| Address |
Neurophysiotherapy Department, DES Brijlal Jindal college of Physiotherapy, Fergusson College Campus, Shivajinagar, Pune- 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
8104905308 |
| Fax |
|
| Email |
madhura.joshi308@deccansociety.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhura Joshi PT |
| Designation |
Post graduate student |
| Affiliation |
D.E.S. Brijlal Jindal college of Physiotherapy |
| Address |
Neurophysiotherapy Department, DES Brijlal Jindal college of Physiotherapy, Fergusson College Campus, Shivajinagar, Pune- 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
8104905308 |
| Fax |
|
| Email |
madhura.joshi308@deccansociety.org |
|
|
Source of Monetary or Material Support
|
| DES Brijlal Jindal College of physiotherapy, Fergusson college campus, Shivajinagar, Pune- 411004, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Madhura Joshi PT |
| Address |
Neurophysiotherapy Department Ground Floor, DES Brijlal Jindal college of Physiotherapy, Fergusson College Campus, Shivajinagar, Pune 411004 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Madhura Joshi |
Neuro rehab centres and community setting |
Neurophysiotherapy department, Ground floor, DES Brijlal Jindal college of Physiotherapy, Fergusson College Campus, Shivajinagar, Pune 411004
Pune
MAHARASHTRA |
8104905308
madhura.joshi308@deccansociety.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC DESBJCOP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EMG Biofeedback therapy combined with Scapular stabilization exercises |
20 minutes of Real- time biofeedback observed in form of graph from muscle electrical activity recorded using surface electrodes combined with scapular stabilization exercise protocol for 7 sessions over 7 days |
| Comparator Agent |
Scapular stabilization exercises |
20 minutes of Scapular strengthening exercises of the scapular stabilization muscles for 7 sessions over 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults diagnosed with ischemic or hemorrhagic stroke.
2. Diagnosed with stroke at least 3 months prior to data collection.
3. Presence of scapular dyskinesis.
4. Visual impairments corrected with prescribed glasses. |
|
| ExclusionCriteria |
| Details |
1. Shoulder joint dysfunction due to any other pathology that may confound scapular dyskinesis assessment or intervention.
2. Unmanageable pain in shoulder or scapular region leading to inability in performing exercises.
3. Any cognitive impairment.
4. Any visual impairment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lateral scapular slide test |
7 days, 1 week |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2025 |
| Date of Study Completion (India) |
15/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
Modification(s)
|
The study aims to explore the combined effect of EMG biofeedback therapy and scapular stabilization exercises in subacute and chronic stroke survivors. In this study, the scapular position will be assessed for scapular dyskinesis in stroke survivors. Following this the protocol will be given for seven days. The control group will be given scapular stabilization exercises while the experimental group will be given EMG biofeedback by surface electrodes which record the muscle electrical activity combined with scapular stabilization exercises. After sessions are conducted for seven days, the scapular position will be reassessed and followed by analysis and interpreted. Owing to the lack of research on the combined effect of EMG biofeedback therapy and Scapular Stabilization exercises, this study will provide valuable insight into the efficacy of the intervention mentioned above for scapular dyskinesis in stroke survivors. |