| CTRI Number |
CTRI/2024/07/071758 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2024 |
| 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
|
Benefits of a play-based exercise program on children with neurological disorders on  cardiovascular fitness |
|
Scientific Title of Study
|
Effect of play based exercise programme on aerobic fitness for individual with neurodevelopmental disability 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 Sham Wayal |
| Designation |
Postgraduate student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Neurophysiotherapy,OPD-05,MGM Institute of Physiotherapy.
Aurangabad
Department of Neurophysiotherapy,OPD-05,MGM Institute of Physiotherapy.
Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7057182883 |
| Fax |
|
| Email |
dr.shamwayal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansoor Rahman A |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Neurophysiotherapy,OPD-05,MGM Institute of Physiotherapy.
Aurangabad
Department of Neurophysiotherapy,OPD-05,MGM Institute of Physiotherapy.
Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7010321409 |
| Fax |
|
| Email |
rahman.paediatry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansoor Rahman A |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Neurophysiotherapy,OPD-05,MGM Institute of Physiotherapy.
Aurangabad
Department of Neurophysiotherapy,OPD-05,MGM Institute of Physiotherapy.
Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7010321409 |
| Fax |
|
| Email |
rahman.paediatry@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neurophysiotherapy,
OPD-5, MGM Institute of Physiotherapy.
Aurangabad
MAHARASHTRA
431003
India |
|
|
Primary Sponsor
|
| Name |
Dr Sham Wayal |
| Address |
Department of Neurophysiotherapy,OPD-5,MGM Institute of Physiotherapy.Aurangabad |
| Type of Sponsor |
Other [Self] |
|
|
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 Sham Wayal |
MGM Medical College and Hospital |
Department of Neuro physiotherapy, Ground Floor
OPD-5, MGM Institute of Physiotherapy.
Aurangabad
MAHARASHTRA
431003
India
Aurangabad
MAHARASHTRA |
7057182883
dr.shamwayal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Researchon Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy Treatment |
1.Active Range of Motion
2.Stretching
3.Bridging
4.Balance Exercise
each exercise last for 10 to 15 min 3sets of 10 repetition
Total duration for control group is 6 weeks |
| Intervention |
play based exercise programme |
A play-based intervention for aerobic fitness in children involves implementing physical activities and exercises that are engaging, enjoyable, and resemble play rather than traditional exercise routines It is a structured games that involve running, jumping, skipping, and other aerobic activities can be included. Examples might include tag, relay races, obstacle courses, and variations of traditional sports adapted to be more child-friendly. The demographic characteristics and pretest measurements will be completed using 10meter shuttle run test, The program will be implemented for six weeks duration in accordance with ACSM guidelines, with a three-days in a week that accounts for a 50 % rest period |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 6-12 years.
2.Children with NDD such as cerebral palsy (GMFCS Level I and II)
3.Children with autism spectrum disorder (level 1 severity as per DSM- 5 criteria)
4.Attention deficit-hyperactivity disorder (children with minor impairment in social and school setting according to DSM-5 criteria)
5. Children Diagnosed with Down syndrome (children with physical and cognitive ability to engage in the activities)
6.Children’s who obeys verbal commands.
|
|
| ExclusionCriteria |
| Details |
1. Any other associated neurological / musculoskeletal/cardiovascular disorder such as instable seizures, cardiac arrhythmia, hip dysplasia.
2. Children with fixed lower limb contractures or deformities affecting stance and gait.
|
|
|
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 |
1.Incremental Shuttle Run Test
|
1.At Baseline and After 6 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.PACE Questionnaire |
10 mins |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
18/08/2024 |
| 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
|
Play-based aerobic exercise intervention that improves aerobic fitness in individuals with neurodevelopmental-developmental disabilities developed by two physiotherapists with five years of experience in the field of neurodevelopmental disability. These play-based exercise program were then validated by an expert in the fields of sports and exercise, and finally a list of ten play-based activities were developed. Approval from the institutional ethics committee will be obtained. Participants will then be recruited based on the inclusion and exclusion criteria from special schools, NGOs and Physiotherapy clinics in and around Chh. Sambhaji Nagar. The participants in the research will then be allocated into two groups (experimental group and control group) using computerized block randomization. The demographic characteristics and pretest measurements will be completed using 10meter shuttle run test. For experimental group, a selection of 10 games will be shown, and at least five of them will be chosen based on the child’s interests, while for the control group conventional therapy will be given. The program will be implemented for six weeks duration in accordance with ACSM guidelines, with a three-days in a week that accounts for a 50 % rest period. Then the post test measurement will be taken. |