| CTRI Number |
CTRI/2023/12/060714 [Registered on: 26/12/2023] 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 muscle fascia release technique on breathing function in children with cerebral palsy |
|
Scientific Title of Study
|
Effect of Myofascial Release Techniques Vs Conventional Physiotherapy on Pulmonary Function in children with Spastic Cerebral Palsy in the age group of 6 to 12 years- 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 Harshada Kumbhar Sonawane |
| Designation |
PhD Scholar |
| Affiliation |
Dr Vithalrao Vikhe Patil Foundations College of Physiotherapy |
| Address |
Cardiorespiratory Physiotherapy Department Dr Vithalrao Vikhe Patil Foundations College of Physiotherapy opp Govt Milk Dairy Vadgaon Gupta Post MIDC Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9545256163 |
| Fax |
|
| Email |
harshadaa.dk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit Diwate |
| Designation |
Professor |
| Affiliation |
Dr Vithalrao Vikhe Patil Foundations College of Physiotherapy |
| Address |
Cardiorespiratory Physiotherapy Department Dr Vithalrao Vikhe Patil Foundations College of Physiotherapy opp Govt Milk Dairy Vadgaon Gupta Post MIDC Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9545256163 |
| Fax |
|
| Email |
abhijitdiwate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshada Kumbhar Sonawane |
| Designation |
PhD Scholar |
| Affiliation |
Dr Vithalrao Vikhe Patil Foundations College of Physiotherapy |
| Address |
Cardiorespiratory Physiotherapy Department Dr Vithalrao Vikhe Patil Foundations College of Physiotherapy opp Govt Milk Dairy Vadgaon Gupta Post MIDC Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9545256163 |
| Fax |
|
| Email |
harshadaa.dk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cardiorespiratory Physiotherapy Department Dr Vithalrao Vikhe Patil Foundations College of Physiotherapy Ahmednagar |
|
|
Primary Sponsor
|
| Name |
Dr Harshada Kumbhar Sonawane |
| Address |
Dr Vithalrao Vikhe Patil Foundations College of Physiotherapy Opp Govt Milk Dairy Vadgaon Gupta Post MIDC Ahmednagar 414111 |
| 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 Harshada Kumbhar Sonawane |
Dr Vithalrao Vikhe Patil Foundations College of Physiotherapy |
Opp Govt Milk Dairy Vadgaon Gupta Post MIDC Ahmednagar
Ahmadnagar
MAHARASHTRA |
9545256163
harshadaa.dk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Padmashri Dr Vithalrao Vikhe Patil Foundations College of Physiotherapy Ahmednagar |
Approved |
| Institutional Ethical Committee Padmashri Dr Vithalrao Vikhe Patil Foundations College of Physiotherapy Ahmednagar |
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 |
Deep Breathing Exercises for 5 minutes three times a day for 4 weeks |
| Intervention |
Myofascial Release Techniques |
25 to 30 minutes twice a week for 4 weeks Total 8 sessions |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children diagnosed with Spastic Cerebral Palsy
2. Age 6 to 12 years
3. Both genders
4. GMFCS level I, II, III
5. Able to sit without support for approximately 30 minutes.
6. Able to close mouth (lips) around the mouthpiece of Spirometer and Micro RPM
devices.
7. Able to understand and follow simple commands.
8. FVC < 80%, FEV1/FVC ratio >/ 85% (Restrictive Pattern)
9. Willing to participate in study. |
|
| ExclusionCriteria |
| Details |
1. Any other neurological or genetic condition which delays overall development of the
child.
2. Any musculoskeletal conditions like fixed spinal deformities, chest deformities
(Pectus Excavatum).
3. Any cardiac conditions like CHD.
4. Any Respiratory Conditions like Asthma, Cystic fibrosis.
5. Moderate to Severe Cognitive dysfunction.
6. Children with cerebral Palsy having moderate to severe visual and auditory
impairments.
7. Children with cerebral Palsy having status epilepticus or severe affection due to
epilepsy/ recent episodes of seizures/ frequent seizures.
8. Any invasive treatment procedure/surgery performed during last 6 to12 months.
9. Severe Oromotor Dysfunction.
10. Children with Athetoid/Ataxic/Hypotonic type of Cerebral Palsy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function tests FVC, FEV1, PEFR, FEV1/FVC |
Baseline, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maximum Inspiratory Pressure (MIP) cmH2O & Maximum Expiratory
Pressure (MEP) cmH2O |
Baseline, 4 weeks, 8 weeks |
Chest Expansion measurements in centimeters(cm)
|
Baseline, 4 weeks, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Children with spastic cerebral palsy in the age group of 6 to 12 years will be assessed for pulmonary function before, at 4 weeks and at 8 weeks post intervention of Myofascial Release techniques along with conventional physiotherapy. |