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Clinical Trials/NCT06659328
NCT06659328
Completed
N/A

Influence of Rhythm and Interpersonal Relationship on Gait Parameters in Children with Autism Spectrum Disorder: a Controlled Intervention Study

Universidad Europea de Madrid1 site in 1 country30 target enrollmentMay 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Universidad Europea de Madrid
Enrollment
30
Locations
1
Primary Endpoint
Cadence
Status
Completed
Last Updated
last year

Overview

Brief Summary

Autism Spectrum Disorder (ASD) affects social communication and motor coordination, with less synchrony with others and atypical gait patterns. Relationship with the adult or speed modify gait parameters in children diagnosed with ASD between 4 and 6 years old. Methodology: a cross-sectional observational design was carried out. The aim of this study was to analyze gait pattern variations in children with ASD in different speed conditions and modifying the social environment.

Detailed Description

Study Design: This is a quasi-experimental, cross-sectional study designed to assess the influence of rhythm and interpersonal relationships on gait parameters in children diagnosed with Autism Spectrum Disorder (ASD). The study involved 30 children, aged 4 to 6, diagnosed with ASD (level I or II), who demonstrated independent walking ability without assistive devices. The children were recruited from Fundación AMÁS, an early intervention center. Intervention: The study aimed to analyze the gait of children under three different speed conditions-normal (120 beats per minute), slow (100 beats per minute), and fast (140 beats per minute)-while walking alongside either a familiar adult or a stranger. The intervention involved the following steps: Preparation: Each child was informed about the walking activity and the adult who would accompany them. They were instructed to walk alongside the adult for a distance of 10 meters. Walking Conditions: Walking with a Familiar Adult: Children walked alongside an adult they knew, maintaining the specified rhythm. Walking with a Stranger: Children walked alongside an unfamiliar adult at the same designated rhythm. Speed Variation: The rhythm was controlled using a metronome, which only the accompanying adult could hear. The adult was instructed to adjust their walking pace according to the specified rhythm while guiding the child. Recording and Analysis: The walking sessions were recorded using a camera positioned at a lateral view, ensuring consistent height and distance. The central 2 meters of the 10-meter path were analyzed using Kinovea© software to assess gait parameters. Outcome Measures: The study sought to evaluate several dependent variables, including: Stride Length: The distance covered with each step. Step Time: The duration of each step. Cadence: The number of steps taken per minute. Velocity: The speed of walking measured in meters per second. Joint Amplitudes: The angles at which the hip, knee, and ankle joints moved during each phase of the gait cycle. Study Population: The study included children with ASD who attended regular therapy sessions at Fundación AMÁS. Inclusion criteria required children to be between 4 and 6 years old, with a clinical diagnosis of ASD (level I or II), and the ability to walk independently. Exclusion criteria included any associated syndromes or recent lower-limb interventions.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
August 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Universidad Europea de Madrid
Responsible Party
Principal Investigator
Principal Investigator

Estrada Barranco

Principal investigator

Universidad Europea de Madrid

Eligibility Criteria

Inclusion Criteria

  • Children aged 4 to 6 years.
  • Clinical diagnosis of Autism Spectrum Disorder (ASD) (Level I or II).
  • Ability to walk independently without the use of assistive devices.
  • Parents or legal guardians provide informed consent for participation.

Exclusion Criteria

  • Presence of other syndromes or developmental disorders.
  • History of recent surgical interventions or procedures involving the lower limbs.
  • Significant neurological or orthopedic conditions that may affect gait.
  • Any contraindications for participation in physical activities as determined by the child's healthcare provider.

Outcomes

Primary Outcomes

Cadence

Time Frame: Immediately before the intervention and immediately after the intervention on the same day

The number of steps taken per minute.

Secondary Outcomes

  • Stride Length(Immediately before the intervention and immediately after the intervention on the same day)
  • Step Time: The duration of each step, measured in seconds(Immediately before the intervention and immediately after the intervention on the same day)
  • Velocity:(Immediately before the intervention and immediately after the intervention on the same day)
  • Joint Amplitudes(Immediately before the intervention and immediately after the intervention on the same day)

Study Sites (1)

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