| CTRI Number |
CTRI/2025/01/078983 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| 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
|
Improving Postural Stability in Children with Autism The Impact of a Gait and Balance Training Program |
|
Scientific Title of Study
|
Effect of gait and balance training program on static and dynamic postural instability among children with autism spectrum disorder-
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 |
Megha Yadav |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
B 512A, Galgotias University, Sector 17A, opp. yamuna expresswa, greater noida, gautam budh nagar, uttar pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9711147463 |
| Fax |
|
| Email |
meghayadav1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Adeeba Ahsan |
| Designation |
Research Scholar |
| Affiliation |
Galgotias University |
| Address |
E005, Galgotias University, Sector 17A, opp. yamuna expresswa, greater noida, gautam budh nagar, uttar pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9810520145 |
| Fax |
|
| Email |
adeebaahsan73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Megha Yadav |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
B 512A, Galgotias University, Sector 17A, opp. yamuna expresswa, greater noida, gautam budh nagar, uttar pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9711147463 |
| Fax |
|
| Email |
meghayadav1987@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Galgotias University, Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida,Gautam Buddh Nagar, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
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 Megha Yadav |
Galgotias University |
Room no, E003, department of physiotherapy, school of allied health sciences, galgotias university, plot no. 02, sector 17-A, yamuna expressway, greater noida, 203201, gautam budh nagar, uttar pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
9711147463
meghayadav1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Commitee Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F948||Other childhood disorders of social functioning, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gait and balance training on firm surfaces |
Gait and balance training on firm surface consist of 3 phases: warm up, main exercise, and cool down.
1.The warm up phase will consist of stretching of the lower extremities and light full-body exercise for 10 minutes.
2. The main exercise phase will consist of 15 minutes of gait training (walking forward, walking backward, and sideways walking), 5 minutes of static balance training (tandem standing and 1 leg standing), and 15 minutes of dynamic balance training (tandem walking, standing on both feet or 1 foot while grabbing the ball and moving it in multiple directions, S-shaped or figure-eight walking, and standing on both feet and giving and receiving a ball). 3. The cool down phase will consist of stretching of the lower extremities and light full-body exercise for 10 minutes. |
| Comparator Agent |
Gait and balance training on mudflat surfaces |
Gait and balance training on mudflat surface consist of 3 phases: warm up, main exercise, and cool down.
1.The warm up phase will consist of stretching of the lower extremities and light full-body exercise for 10 minutes.
2. The main exercise phase will consist of 15 minutes of gait training (walking forward, walking backward, and sideways walking), 5 minutes of static balance training (tandem standing and 1 leg standing), and 15 minutes of dynamic balance training (tandem walking, standing on both feet or 1 foot while grabbing the ball and moving it in multiple directions, S-shaped or figure-eight walking, and standing on both feet and giving and receiving a ball). 3. The cool down phase will consist of stretching of the lower extremities and light full-body exercise for 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Autistic children between 6 and 12 years of age written agreement with the research processes
Absence of malnutrition
Interest in participating in the intervention program
|
|
| ExclusionCriteria |
| Details |
children having developmental disorder other than autism.
children who have undergone any surgery.
|
|
|
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 |
The Pediatric Balance Scale evaluates balance in school-aged children through 14 tasks scored 0–4, with a maximum of 56 points. The Single-Leg Stance (SLS) test measures static balance by timing participants standing on one leg with arms crossed and eyes forward. Trials stop if balance is lost or eyes open during eyes-closed tests. SLS is assessed in both eyes-open and eyes-closed conditions. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The 10MWT is commonly used to evaluate gait velocity. Patients walked 10 m, and the walking speed was calculated using the middle 6 m, excluding the first and last 2 m. Patients instructed to walk at a comfortable speed. The test will be performed twice in each condition, and the average value will be used for the analysis.
The TUG test is a reliable and valid tool for measuring functional mobility. The subjects stand up from a chair with an armrest, walk about 3 m, turn around, walk back to the chair, and sit down. The time taken to perform this process is measured. |
Assessment on the 0 day, followed by 4 weeks follow up. |
|
|
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)
|
30/01/2025 |
| 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="1"
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
|
This
study aims to evaluate the efficacy of a gait and balance training
program on an unstable mudflats surface for children with Autism
Spectrum Disorder (ASD). ASD is characterized by atypical
development, social communication deficits, repetitive behaviors, and
motor impairments, including distinct gait patterns and reduced
postural stability, which increase the risk of falls. Physical
exercise has been shown to improve motor performance, coordination,
and sensory capacities in children with ASD. Participants will be
randomly assigned to an experimental group, training on mudflats, or
a control group, training on a firm indoor surface. Both groups will
engage in a supervised 55-minute session, 3 days a week, for 4 weeks,
comprising warm-up, main exercises, and cool-down phases. The study
will compare the effectiveness of these surfaces in improving gait
and balance.
|