CTRI Number |
CTRI/2022/02/040079 [Registered on: 07/02/2022] Trial Registered Prospectively |
Last Modified On: |
22/05/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Other |
Public Title of Study
|
Immediate effect of Myofascial release (MFR) versus Joint
mobilization on spasticity and range of motion (ROM) in stroke. |
Scientific Title of Study
|
Immediate effect of Myofascial release versus Joint
mobilization on Spasticity and Range of motion of forearm and
hand in subacute and chronic stroke- A 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 |
Dr Anil muragod |
Designation |
HOD AND PROFESSOR OF GERIATRIC DEPARTMENT |
Affiliation |
KAHER Institute of Physiotherapy |
Address |
Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr prabhakar kore hospital,
Belgaum KARNATAKA 590010 India |
Phone |
|
Fax |
|
Email |
anilmurgod@klekipt.edu.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anil muragod |
Designation |
HOD AND PROFESSOR OF GERIATRIC DEPARTMENT |
Affiliation |
KAHER Institute of Physiotherapy |
Address |
Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr prabhakar kore hospital
Belgaum KARNATAKA 590010 India |
Phone |
|
Fax |
|
Email |
anilmurgod@klekipt.edu.in |
|
Details of Contact Person Public Query
|
Name |
Minal Karani |
Designation |
Post graduate physiotherapy student |
Affiliation |
KAHER Institute of Physiotherapy |
Address |
Advanced physiotherapy centre, Room no 39 ,sagar floor, KLE Dr prabhakar kore hospital
Belgaum KARNATAKA 590010 India |
Phone |
|
Fax |
|
Email |
karaniminal99@gmail.com |
|
Source of Monetary or Material Support
|
KLE Dr. Prabhakar Kore hospital and MRC, Belagavi |
|
Primary Sponsor
|
Name |
Minal Karani |
Address |
Shivbasava nagar
Belagavi
590010 |
Type of Sponsor |
Other [Self sponsored] |
|
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 |
Minalkarani |
KLE Dr. Prabhakar Kore hospital . |
Sagar floor, advanced physiotherapy center, room no. 39, KLE Dr. Prabhakar Kore hospital and MRC Belgaum KARNATAKA |
9082926556
karaniminal99@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Research and Ethics Committee of KAHER Institute of physiotherapy |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Joint mobilization |
Joint mobilization is given for 12 mins to wrist, scaphoid and lunate. |
Intervention |
MFR |
MFR is given for 6mins on flexor aspect of forearm |
|
Inclusion Criteria
|
Age From |
46.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Subacute and chronic stoke.
MAS score 1-3.
Brunnstrom grading 3/>.
Participants who can communicate and cooperate. |
|
ExclusionCriteria |
Details |
MSK conditions.
Sensory impairments.
Perceptual disorders.
Other neurological disorders.
|
|
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. |
Baseline, immediately after intervention |
|
Secondary Outcome
|
Outcome |
TimePoints |
Universal Goniometer. |
Baseline, immediately after intervention |
|
Target Sample Size
|
Total Sample Size="18" Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
12/02/2022 |
Date of Study Completion (India) |
20/03/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
20/03/2022 |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study aims to determine immediate effect of myofascial release versus joint mobilization on wrist flexor spasticity and wrist extension range of motion. There will be two groups and 9 participants in each. First group will be given conventional therapy with MFR for 36 mins and second group will be given conventional therapy with joint mobilization for 42mins. MTS score for wrist flexor spasticity and wrist extension with goniometer is taken pre and post intervention. |