| 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
|
|
|
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
|
|
|
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. |