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CTRI Number  CTRI/2024/04/066284 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 22/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of physical activity training versus basic movement skill training in school aged children with disabilities 
Scientific Title of Study   A comparative study to find the effect of Physical activity training Versus Fundamental movement skill training on Physical activity level and Wellbeing among children with disability in school setting 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swetha Sukumaran P 
Designation  Postgraduate Student 
Affiliation  The Oxford College of Physiotherapy 
Address  The Department of Musculoskeletal sciences-Physiotherapy,No.6/9A,1st cross,Begur road,Hongasandra,Bengaluru-560068

Bangalore
KARNATAKA
560068
India 
Phone  9113874173  
Fax    
Email  ponnussprlm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr R V Vijayakumar 
Designation  Assistant Professor 
Affiliation  The Oxford College of Physiotherapy 
Address  The Department of Musculoskeletal sciences-Physiotherapy,No.6/9A,1st cross,Begur road,Hongasandra,Bengaluru-560068

Bangalore
KARNATAKA
560068
India 
Phone  09448482319  
Fax    
Email  rvvijay1976@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr R Vasanthan 
Designation  Principal 
Affiliation  The Oxford College of Physiotherapy 
Address  The Department of Musculoskeletal sciences-Physiotherapy,No 6/9A,1st cross,Begur road,Hongasandra,Bengaluru-560068

Bangalore
KARNATAKA
560068
India 
Phone  09916919685  
Fax    
Email  physiotherapyprincipal@theoxford.edu  
 
Source of Monetary or Material Support  
Asare Special School, Micolayout,Hongsandra,bengaluru,karnataka,560068 
Credence A Ray Of Hope, 24th cross,independence park,2nd sector,HSR layout,Bengaluru,Karnataka-560102 
Samarthanam Trust For The Disabled, 15th cross,16th main, sector 4,HSR Layout,Bengaluru-560102 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Swetha Sukumaran P  Asare Special School  Micolayout,Hongsandra,bengaluru,karnataka,560068
Bangalore
KARNATAKA 
9113874173

ponnussprlm@gmail.com 
Swetha Sukumaran P  Credence a ray of hope  24th cross,independence park,2nd sector,HSR layout,Bengaluru,Karnataka-560102
Bangalore
KARNATAKA 
9113874173

ponnussprlm@gmail.com 
Swetha Sukumaran P  Samarthanam Trust for disabled  15th cross,16th main,sector 4,HSR Layout,Bengaluru-560102
Bangalore
KARNATAKA 
9113874173

ponnussprlm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Oxford College of Physiotherapy Review Board for Ethics and Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fundamental movement skill training  Basic motor skills including object control and locomotor skill training for a period of 4 weeks 
Intervention  Physical activity training  Structured physical activity training with adequate duration and mild to moderate intensity for a period of 4 weeks 
 
Inclusion Criteria  
Age From  9.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children with motor impairment according to M-ABC
Children with physical disabilities and mild intellectual disabilities according to DSM-V 
 
ExclusionCriteria 
Details  Children with acute musculoskeletal condition or injury(Recent fractures,Sprain)
Children with acute inflammatory conditions
Children with visual and hearing impairment
children who are not able to follow commands 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Physical activity level using The Physical Activity Questionnaie for Older Children(PAQ-C)  0 week and 5th week 
 
Secondary Outcome  
Outcome  TimePoints 
Wellbeing using The Stirling Childrens wellbeing Scale  0 week and 5th week 
 
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   Phase 4 
Date of First Enrollment (India)   04/05/2024 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Background: Children with disabilities(CWD),facing long-term physical and mental impairments, is recognized to improve their quality of life and effective participation in society by engaging in physical activity. CWD often fall short of recommended activity levels, posing a global health concern. Fundamental movement skills including basic motor skills acts as a key factor that can influence physical activity participation. Recognizing the gap, a need emerges for research comparing the effects of structured physical activity training with fundamental movement skill training, on physical and mental wellbeing of Children with disabilities.
Method: In this parallel group RCT study,30 participants aged 9-14 years with physical and mild intellectual disabilities from special schools in Bangalore will be enrolled in a 4-week physical activity program. Through simple random allocation, they will be randomized(1:1) to either physical activity training or fundamental movement skill training. Exclusions will be comprised of children with sensory impairment or acute musculoskeletal and inflammatory conditions or who are not able to follow commands.
Main Outcome measures: Physical activity level and Well-being will be assessed pre and post intervention using the Physical Activity Questionnaire for Children(PAQ-C) and The Stirling Childrens Wellbeing Scale(SCWBS)respectively.
Data analysis: The results will be analysed using descriptive statistics, paired t test for finding the effectiveness within groups and unpaired t test for finding the effectiveness between the groups.
 
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