| CTRI Number |
CTRI/2024/07/070529 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Myofascial Release Techniques and Conventional Physiotherapy on Upper Limb Function in children with Spastic Cerebral Palsy |
|
Scientific Title of Study
|
Effect of Myofascial Release Techniques Vs Conventional Physiotherapy on Upper Limb Function in Children with Spastic Cerebral Palsy in age group of 6 to 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 |
Kunal Duryodhan Dhoble |
| 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 |
08669034073 |
| Fax |
|
| Email |
kdhoble120@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harshada Sonawane |
| Designation |
Associate Professor |
| Affiliation |
DES Brijlal Jindal college of Physiotherapy |
| Address |
Ground floor, Neurophysiotherapy department, DES Brijlal Jindal college of Physiotherapy
Pune
MAHARASHTRA
411004
India
Pune
MAHARASHTRA
411004
India |
| Phone |
9545256163 |
| Fax |
|
| Email |
harshadaa.dk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kunal Duryodhan Dhoble |
| Designation |
PG Student |
| Affiliation |
D E S Brijlal Jindal College of Physiotherapy |
| Address |
Neurophysiotherapy Department Ground Floor D E S Brijlal Jindal College of Physiotherapy F. C. Road Shivajinagar
Pune
Fergusson College Campus F. C. Road, Shivajinagar
Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
8669034073 |
| Fax |
|
| Email |
kdhoble120@gmail.com |
|
|
Source of Monetary or Material Support
|
| DES Brijlal Jindal College of Physiotherapy, Pune
Maharashtra,India
411004 |
|
|
Primary Sponsor
|
| Name |
Kunal Dhoble |
| Address |
Ground Floor,
Neurophysiotherapy department,
DES Brijlal Jindal College of Physiotherapy,
Pune |
| 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 |
| Kunal Dhoble |
DES Brijlal Jindal college of Physiotherapy |
Outpatient Department Gate no. 2 Fergusson College Shivajinagar
Pune
Pune
MAHARASHTRA |
8669034073
kdhoble120@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 |
Stretching of Spastic Muscle 5 Repetition with 60 second hold for 2 times a week for 4 weeks, Strengthening of antagonist muscle 12 repetition 2 times a week for 4 weeks |
| Intervention |
Myofascial release technique |
Diaphragmatic and thoracic inlet Myofascial release techniques
3 sets for 90 sec, 2 times a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Spastic Cerebral Palsy
2)GMFCS level 1,2,3,4
3)MACS level 1,2,3 |
|
| ExclusionCriteria |
| Details |
1)Upper limb pathology
2)Uncooperative child
3)Severely impaired cognition and communication
4)Child with pulmonary conditions which affects diaphragm
5)Mental retardation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Melbourne Assessment of upper limb function |
Baseline, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Jebson Hand Function Test assesses hand function |
Baseline.4 weeks |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
25/07/2024 |
| 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
|
In the study titled ’Effect of Myofascial Release Techniques Vs Conventional Physiotherapy On Upper Limb Function In Children With Spastic Cerebral Palsy in Age Group of 6 to 12 Years -A Pilot Study" , we propose to assess the upper limb function in both control and experimental groups.
Post assessment, control and experimental group participants will receive conventional physiotherapy in the form of stretching of spastic &/or tight muscles and strengthening of antagonist muscles.
Experimental group participants in addition will receive the intervention of Myofascial release therapy using Diaphragmatic and Thoracic inlet release techniques.
Both interventions will be delivered over 4 weeks duration and reassessment will be done at the end of 4 weeks.
Data will be analyzed using appropriate statistical tests. results will be discussed and then published.
|