| CTRI Number |
CTRI/2024/12/077548 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| 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
|
This study compares immediate effects of two techniques called Instrument Assisted Soft Tissue Mobilization and Myofascial Release Therapy in patients with subacute and chronic stroke to reduce muscle pain, improve range of motion of shoulder and function |
|
Scientific Title of Study
|
Immediate effects of Instrument Assisted Soft Tissue Mobilization and Myofascial Release Therapy on trigger points in patients with subacute and chronic stroke-A comparative 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 |
Joan Dmello |
| Designation |
MPT Scholar |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy 2nd floor room no 115 MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
7028523726 |
| Fax |
|
| Email |
joandmello@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrutika Parab |
| Designation |
Associate Professor |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy 2nd floor room no 115 MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
shrutikaparab.mgmsop@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrutika Parab |
| Designation |
Associate Professor |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy 2nd floor room no 115 MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
shrutikaparab.mgmsop@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy, MGM Hospital, Sector 1 Plot 1 and 2 Kamothe, Navi Mumbai Taluka Panvel, India, 401209 |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy 2nd floor room no 115 MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrutika Parab |
MGM School of Physiotherapy MGM Institute of Health Sciences |
MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy Neuro Adult IPD Neuro OPD MGM Hospital Sector 1 Plot 1 and 2 Kamothe Navi Mumbai Taluka Panvel
Raigarh
MAHARASHTRA |
02227437866
shrutikaparab.mgmsop@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahatma Gandhi Missions Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G46||Vascular syndromes of brain in cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instrument Assisted Soft Tissue Mobilization |
Instrument Assisted Soft Tissue Mobilization is a manual therapy technique using specialized tools to treat soft tissue restrictions and promote healing using slow, sustained strokes for 120 seconds |
| Comparator Agent |
Myofascial Release Therapy |
Myofascial Release is a hands-on approach that targets muscle fascia to relieve tension and improve mobility using slow, sustained strokes for 120 seconds |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
The study will include both male and female patients aged 55 to 75 years who have been diagnosed with stroke either in the subacute phase 3 to 6 months or chronic phase over 6 months. Participants must have Modified Ashworth Scale scores ranging from Grade 1 to 3 and voluntary control grades from 2 to 4. The presence of latent trigger points in the scapular region is also a requirement |
|
| ExclusionCriteria |
| Details |
The study will exclude patients with sensory impairment and those with a history of upper extremity fractures or other musculoskeletal injuries. Participants with skin conditions malignancies or peripheral vascular diseases will also be excluded. Additional exclusion criteria include the presence of open wounds recent surgeries dislocated or subluxated shoulders and winged scapula. Patients currently undergoing cupping treatment will also not be considered for the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Pain- Wong Baker scale
2 Range of motion of
Shoulder- Kinovea and
Goniometer |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional status- SPADI |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
14/01/2025 |
| 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
|
The study aims to investigate the Immediate effects of Instrument Assisted Soft Tissue Mobilization and Myofascial Release Therapy on trigger points in patients with subacute and chronic stroke. Stroke patients with hypertonicity have trigger points which gets unnoticed and could be a contributing factor towards reduced range of motion, function and increased pain. Hence this Study will be focusing on 3 main criterias to improve pain, range of motion of shoulder and functional status. Two different techniques will be used which are Instrument Assisted Soft Tissue Mobilization and Myofascial Release Therapy. The research seeks to determine the immediate effects between and within these two techniques. The methodology involves assessing pain through Wong baker scale, range of motions of shoulder (abduction, flexion, adduction, extension, medial and lateral rotation) through kinovea and goniometer and SPADI for functional status. The study will recruit patients diagnosed with subacute and chronic stroke aged 55-75 years. There is dearth of literature on comparing IASTM and MFRT on myofascial trigger points in scapular muscles in patients with hypertonic subacute and chronic stroke, hence this study is been undertaken |