| CTRI Number |
CTRI/2024/06/069547 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| 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
|
An exercise program to study the effect of sport training on physical and cognitive function in children with intellectual disability |
|
Scientific Title of Study
|
Effect of 12-week adaptive sport training on physical and cognitive functions in children with mild intellectual disability- a pilot interventional 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 |
Shivani N Chavan |
| Designation |
Postgraduate Student |
| Affiliation |
MGM School of Physiotherapy, MGM Institute of health science |
| Address |
Department of MGM School of Physiotherapy, MGM Institute of health science, OPD room no 55, Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra 410209
Department of MGM School of Physiotherapy, MGM Institute of health science, OPD room no 55, Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9819309823 |
| Fax |
|
| Email |
shivanichavan@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Triveni Shetty |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of health science |
| Address |
Department of MGM School of Physiotherapy, MGM Institute of health science, OPD room no 55, Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra 410209
Department of MGM School of Physiotherapy, MGM Institute of health science, OPD room no 55, Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
tshetty@mgmsopnm.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Triveni Shetty |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of health science |
| Address |
Department of MGM School of Physiotherapy, MGM Institute of health science, OPD room no 55, Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra 410209
Department of MGM School of Physiotherapy, MGM Institute of health science, OPD room no 55, Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
tshetty@mgmsopnm.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM Institute of health science
MGM School of Physiotherapy Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra 410209
|
|
|
Primary Sponsor
|
| Name |
MGM school of physiotherapy |
| Address |
MGM Institute of health science
MGM School of Physiotherapy Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra 410209
|
| Type of Sponsor |
Private medical college |
|
|
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 Shivani Chavan PT |
MGM School of Physiotherapy, MGM Institute of Health Sciences |
Department of MGM School of Physiotherapy, MGM Institute of health science, OPD room no 55, Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra 410209
Mumbai
MAHARASHTRA |
9819309823
shivanichavan@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F70||Mild intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Includes 26 ambulatory children who will be following the regular therapy program and Children who do not attend sports program at school level for the past 6 months |
| Intervention |
Experimental group |
Includes 26 ambulatory children who will be following the intervention and Children who do not attend sports program at school level for the past 6 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Fifty two ambulatory children diagnosed with mild intellectual disability with an IQ score between 50 to 75 age group 6 to 14) {According to ICD 10 classification Code (G 80)
Children willing to participate in the study
Children who will be able to follow an exercise intervention and who are able to follow verbal commands
Children diagnosed with Down syndrome, cerebral palsy (GMFCS level 1 and 2) ADHD, Autism, fine motor dysfunction {According to ICD 10 classification Code (G 80)}
|
|
| ExclusionCriteria |
| Details |
Children diagnosed with cerebral palsy with GMFCS level 3,4,5 According to ICD 10 classification Code (G 80) Children attending a sports program at school level for the past 6 months
Children having any uncorrected cardiovascular abnormalities {According to ICD 10 classification Code: (I00 to I99)}
Children taking any medications that could interfere with the study results
Children who underwent recent surgery in the past one year
Any existing fracture or soft tissue injuries, pulmonary, metabolic and psychological condition which affects the performance {Disorders of continuity of bone M 84, Other disorders of bone density and structure M85, Disorder of eye and adnexa (H0 to H59), Diseases of the respiratory system (J0 to J99)}
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pediatric quality of life scale- to assess physical activity and participation
GMFM-88(Gross motor function measure)- to assess physical activity and participation
Pediatric balance scale- To assess balance |
Baseline and 12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Zig zag test is to assess agility
10 m sprint test is to assess Speed
Modified sit & reach test is to assess flexibility
D2 test of attention To assess selective attention
|
Baseline & 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
10/08/2024 |
| 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
|
To explore the effect of 12-week adaptive sport training on physical and cognitive functions in children with mild intellectual disability To evaluate and compare the effect on physical functions including agility, speed, balance and flexibility in children with mild intellectual disability for a 12-week pre and post adaptive sport training intervention To evaluate and compare the effect on cognitive functions including selective attention in children with mild intellectual disability for a 12-week pre and post adaptive sport training intervention The expected outcome of the study is to investigate the effects of adaptive sport training on physical and cognitive functions in children with mild intellectual disability |