| CTRI Number |
CTRI/2023/09/058067 [Registered on: 27/09/2023] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| 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 Myofascial Release Technique on sitting balance in Spastic Cerebral Palsy children |
|
Scientific Title of Study
|
Effect of Myofascial Release Technique Vs Conventional Physiotherapy on Trunk Control in children with Spastic Cerebral Palsy in the age group of 8-12 years- 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 |
Sakshi Harshwardhan Dupare |
| Designation |
PG student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Ground floor, Neurophysiotherapy department, DES Brijlal Jindal college of Physiotherapy
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
sakshidupare6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harshada Sonawane |
| Designation |
Associate Professor |
| Affiliation |
D.E.S BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY |
| Address |
Ground floor, Neurophysiotherapy department, D.E.S BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY
Pune
MAHARASHTRA
411004
India |
| Phone |
9545256163 |
| Fax |
|
| Email |
harshadaa.dk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Harshwardhan Dupare |
| Designation |
PG student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Ground floor, Neurophysiotherapy department, DES Brijlal Jindal college of Physiotherapy
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
sakshidupare6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ground floor, Neurophysiotherapy department, DES Brijlal Jindal college of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sakshi Dupare |
| Address |
Survey no 52, Lane no 5/5C, Bhairav nagar, Dhanori road, Pune-411015 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Sakshi Dupare |
D.E.S Brijlal Jindal College of Physiotherapy |
Ground floor, Neurophysiotherapy department, DES Brijlal Jindal college of Physiotherapy
Pune
MAHARASHTRA |
8830192704
sakshidupare6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DES Brijlal Jindal College of Physiotherapy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Trunk Control Exercises for 4 weeks |
| Intervention |
MYOFASCIAL RELEASE TECHNIQUE |
Diaphragmatic and thoracic inlet myofascial release techniques |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Child diagnosed with spastic cerebral palsy
GMFCS level 1,2,3,4 |
|
| ExclusionCriteria |
| Details |
Uncooperative children
Visual and intellectual difficulties
Severely impaired cognition and communication
Child with cardiovascular or pulmonary condition which affect diaphragm
Other neurological or musculoskeletal condition which has affected diaphragm
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trunk Control Measure scale, Trunk Impairment scale, Modified Pediatric Reach test |
Baseline, 4th week |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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)
|
This study titled "Effect of Myofascial release technique v/s Conventional physiotherapy on Trunk control in children with Spastic Cerebral Palsy in the age group of 8-12 years- a pilot study" recruited 24 participants.
There were 2 groups- Experimental group and Control group. Experimental group was given MFR with conventional physiotherapy for 25 mins/session for twice a week and Control group was given conventional physiotherapy for 25 mins/session twice a week for 4 weeks.
Pre and Post intervention assessment done by TCMS, TIS and Modified PRT showed significant improvement on trunk control in spastic cerebral palsy children (p<0.001)
Hence, we conclude that MFR with Conventional physiotherapy is effective in improving trunk control in spastic cerebral palsy children in the age group of 8-12 years.
|