| CTRI Number |
CTRI/2025/08/093670 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| 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
|
A study to find out efficacy of prone positioning in chronic stroke patients |
|
Scientific Title of Study
|
Effectiveness of Wakeful Prone Positioning Maneuver to improve Sensorimotor function and Balance in Chronic Stroke Patients-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 |
Komal Dalvi |
| Designation |
Postgraduate student |
| Affiliation |
YMT College Of Physiotherapy |
| Address |
Room no 301, Department of Neurophysiotherapy Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8450986265 |
| Fax |
|
| Email |
komaldalvi03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Ramesh |
| Designation |
Professor and Guide |
| Affiliation |
YMT College Of Physiotherapy |
| Address |
Room no 301, Department of Neurophysiotherapy Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7874856011 |
| Fax |
|
| Email |
natraam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Ramesh |
| Designation |
Professor and Guide |
| Affiliation |
YMT College Of Physiotherapy |
| Address |
Room no 301, Department of Neurophysiotherapy Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7874856011 |
| Fax |
|
| Email |
natraam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neurophysiotherapy Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar, Navi Mumbai,410210, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Komal Dalvi |
| Address |
Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra, 410210 |
| 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 |
| Komal Dalvi |
YMT College Of Physiotherapy |
Department of Neurophysiotherapy
Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra, 410210
Raigarh
MAHARASHTRA |
8450986265
komaldalvi03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YMT COP Institutional Ethics 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 |
Conventional exercises |
Strengthening, stretching and balance exercises for 45 minutes for 5 times a week for 6 weeks |
| Intervention |
Wakeful prone positioning |
Prone position maneuver for 30 minutes for 5 times a week along with 45 minutes of conventional exercises for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Chronic stroke duration more than 6 Months
Ischemic or hemorrhagic stroke patients
Patients with MCA stroke
Able to understand and follow simple verbal instructions (MOCA score greater than or equal to 26)
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensorimotor function and Balance |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
15/09/2025 |
| 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 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 a randomized, single blind, parallel group, single centered trial to find out the effectiveness of Wakeful Prone positioning maneuver and conventional exercises on Sensorimotor function and Balance in Chronic Stroke Patients for 6 weeks. Total participants included in the study are 36 and randomized into 18 in intervention and 18 in control groups. Outcome measures Fugl-Meyer Assessment of Upper Extremity (FMA-UE) and Lower Extremity (FMA-LE) for measuring the severity of sensorimotor dysfunction and Berg Balance Scale (BBS) for balance will be used.
|