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Clinical Trials/CTRI/2025/01/078983
CTRI/2025/01/078983
Not yet recruiting
Not Applicable

Effect of gait and balance training program on static and dynamic postural instability among children with autism spectrum disorder- A randomized controlled trial

Galgotias University1 site in 1 country52 target enrollmentStarted: January 30, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Galgotias University
Enrollment
52
Locations
1
Primary Endpoint
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.

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
6.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • children having developmental disorder other than autism.
  • children who have undergone any surgery.

Outcomes

Primary Outcomes

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.

Time Frame: 4 weeks

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Galgotias University
Sponsor Class
Research institution
Responsible Party
Principal Investigator
Principal Investigator

Megha Yadav

Galgotias University

Study Sites (1)

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