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CTRI Number  CTRI/2023/02/049429 [Registered on: 03/02/2023] Trial Registered Prospectively
Last Modified On: 18/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Yoga Intervention]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Healing effects of Yoga on walking performance and capacity, balance, leg strength, and flexibility in walking children with cerebral palsy 
Scientific Title of Study   Therapeutic effects of Yoga on gait variables, walking capacity, balance, lower extremity strength, and flexibility in ambulatory children with cerebral palsy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Labddhi Ramnik Shah 
Designation  Master of Physiotherapy Student 
Affiliation  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy second floor Room no 55 MGM Hospital Sector 1 plot no 1 and 2 Kamothe Navi Mumbai Taluka Panvel India

Raigarh
MAHARASHTRA
410209
India 
Phone  02227437866  
Fax    
Email  Shahlabddhi@mgmsopnm.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Amrita Ghosh PT 
Designation  Assistant Professor HOD of Neuro Physiotherapy 
Affiliation  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy second floor Room no 55 MGM Hospital Sector 1 plot no 1 and 2 Kamothe Navi Mumbai Taluka Panvel India

Raigarh
MAHARASHTRA
410209
India 
Phone  02227437866  
Fax    
Email  aghosh@mgmsopnm.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Amrita Ghosh PT 
Designation  Assistant Professor HOD of Neuro Physiotherapy 
Affiliation  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy second floor Room no 55 MGM Hospital Sector 1 plot no 1 and 2 Kamothe Navi Mumbai Taluka Panvel India

Raigarh
MAHARASHTRA
410209
India 
Phone  02227437866  
Fax    
Email  aghosh@mgmsopnm.edu.in  
 
Source of Monetary or Material Support  
MGM School of Physiotherapy MGM Institute of Health Sciences MGM Educational campus Sector 1 plot no 1 and 2 Kamothe Navi Mumbai 
 
Primary Sponsor  
Name  MGM School of Physiotherapy MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy MGM Institute of Health Sciences MGM Educational Campus Sector 1 plot no 1 and 2 Kamothe Navi Mumbai Taluka Panvel Raigad Maharashtra 410209 India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Labddhi Ramnik Shah  MGM School of Physiotherapy  MGM School of Physiotherapy MGM Institute of Health Sciences Department of Physiotherapy second floor Room no 55 MGM Hospital Sector 1 plot no 1 and 2 Kamothe Navi Mumbai Taluka Panvel Raigad Maharashtra 410209 Raigarh MAHARASHTRA
Raigarh
MAHARASHTRA 		 02227437866

Shahlabddhi@mgmsopnm.edu.in 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G809||Cerebral palsy, unspecified, (2) ICD-10 Condition: G830||Diplegia of upper limbs, (3) ICD-10 Condition: G819||Hemiplegia, unspecified, (4) ICD-10 Condition: G831||Monoplegia of lower limb, (5) ICD-10 Condition: G832||Monoplegia of upper limb, (6) ICD-10 Condition: G833||Monoplegia, unspecified, (7) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (8) ICD-10 Condition: G811||Spastic hemiplegia, (9) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Control group will include 12 weeks of conventional therapy with supervised sessions for 2-3 days/week for 60 minutes, including breathing exercises, exercises specific to gait, balance, strength, flexibility, and improving walking capacity 
Intervention  Sukshma Vyayama Ashwa Sanchalanasana Virbhadrasana I and II Uttakasana Utkat Konasana Paschimottasana Trikonasana Ugrasan Naukasana Annulom-Vilom and Bhramari  Interventional group will be provided 12weeks (three sessions/week) supervised Yoga sessions for 2-3 days/week for 60 minutes. The Yoga Asanas will include Sukshma Vyayama Ashwa Sanchalanasana Virbhadrasana I and II Uttakasana Utkat Konasana Paschimottasana Trikonasana Ugrasan Naukasana Annulom-Vilom and Bhramari. In the initial 4 weeks, the participants will perform 3 repetitions each asana with 15 seconds hold/repetition. In the 5th to 8th week based on the tolerance and performance the participants will be given progression dose i.e. each asana will be performed 4 times with 30 second hold/repetition. A similar progression will be followed in the final 9-12 weeks based on tolerance and performance 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Fifteen ambulatory children diagnosed with cerebral palsy according to ICD-10 G.80 Spastic diplegic cerebral palsy G.80.1 Spastic hemiplegic cerebral palsy G.80.2 Cerebral palsy unspecified G.80.9 Spastic hemiplegia G.81.1 Hemiplegia unspecified G.81.9 Diplegia of upper limbs Diplegia upper Paralysis of both upper limbs G83.0
Monoplegia of lower limb Paralysis of lower limb G83.1 Monoplegia of upper limb Paralysis of upper limb G83.2 Monoplegia unspecified G83.3
2. Age group 6 to 18 years of age.
3. Children with GMFCS Level I and II
4. Patients able to follow verbal commands.
5. Control group: Fifteen ambulatory children with cerebral palsy ICD-10 G.80 in the age group 6 years to 18 years not involved in any physical recreational or sports activity
 
 
ExclusionCriteria 
Details  1. Acute musculoskeletal injury soft tissue in the past 3 months.
2. Any fracture or other traumatic injury in the past 6 months
3. Any bony or soft tissue surgery in the past 12 months.
4. Botulinum injection in the past 6 months
5. Children with visual and auditory disabilities.
6. Children with spastic quadriplegic cerebral palsy spastic tetraplegic cerebral palsy G80.0 Dyskinetic cerebral palsy Athetoid cerebral palsy Dystonic cerebral palsy G80. 3 Ataxic cerebral palsy G80. 4 Other cerebral palsy Mixed cerebral palsy syndrome G80.8 Flaccid hemiplegia G81.0 Flaccid paraplegia G82.0 Flaccid tetraplegia G82.3 Spastic tetraplegia G82.4 Tetraplegia unspecified Quadriplegia NOS G82.5 Cauda equina syndrome Neurogenic bladder due to cauda equina syndrome G83.4 Excl cord bladder NOS G95.8 Other specified paralytic syndromes Todd paralysis postepileptic G83.8 Paralytic syndrome unspecified G83.9
7. Patients with a history of lower limb fractures less than 1-year-old
8. Mental and Behavioral disorders F00-F99
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Gait using Movement analysis profile Kinematics and kinetics of gait in terms of joint angles moments forces the center of pressure trajectory and maximum amplitude of muscle activity will be the primary outcome measures.  Baseline 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Walking capacity using the 6-Minute Walk Test
2. Balance using the Pediatric Balance Scale
3. Strength of lower extremity using Power track handheld dynamometer
4. Flexibility of lower extremity using goniometer measurements 		 Baseline 12 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   12/02/2023 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study will compare the effects of Yoga techniques and conventional physiotherapy on gait variables, walking capacity, balance, lower extremity strength, and flexibility in ambulatory children with cerebral palsy. The study will be conducted for 12 weeks 2-3 day/week supervised program for 60 minutes. The intervention will be Yoga techniques and conventional physiotherapy for the experimental group and conventional physiotherapy for the control group. The primary outcome measure for Gait will be Movement analysis profile Kinematics and kinetics of gait in terms of joint angles, moments, forces, the center of pressure trajectory, and maximum amplitude of muscle. The secondary outcome measures will be 1. 6-Minute Walk Test for walking capacity 2. Pediatric Balance Scale for balance 3. Power track handheld dynamometer for lower extremity strength 4. Goniometer measurements for lower extremity flexibility. Pre and Post-intervention results will be analyzed.

 
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