NCT06659328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 4, 2024

Last Update Submit

October 23, 2024

Conditions

Keywords

autismstabilityinterpersonal relationshipgait patternsproprioception

Outcome Measures

Primary Outcomes (1)

  • Cadence

    The number of steps taken per minute.

    Immediately before the intervention and immediately after the intervention on the same day

Secondary Outcomes (4)

  • 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 Arms (1)

Walking Intervention with Varying Speeds and Social Interaction in Children with Autism Spectrum Dis

EXPERIMENTAL

This arm of the study focuses on a single group of participants consisting of 30 children aged 4 to 6 years diagnosed with ASD. The objective is to evaluate how varying walking speeds and social interactions influence gait parameters. Participants will engage in a structured walking intervention under three conditions: normal speed (120 bpm), slow speed (100 bpm), and fast speed (140 bpm). Each child will walk with two different types of adult companions: a familiar adult (e.g., caregiver) and an unfamiliar adult. This design allows for a comprehensive assessment of gait characteristics in response to different social contexts and pacing. Each child will complete a 10-meter walking task, with gait parameters such as stride length, step time, cadence, velocity, and joint amplitudes being recorded using video analysis software (Kinovea©).The results will contribute to understanding how children with ASD adapt their locomotion to social cues and varying speeds

Procedure: Structured Walking Intervention for Children with Autism Spectrum Disorder

Interventions

Participants: Thirty children with ASD will participate in the walking sessions. Conditions: Each child will walk under three different speed conditions: Normal Speed: 120 beats per minute (bpm) Slow Speed: 100 bpm Fast Speed: 140 bpm Social Interaction: Each child will walk with two different types of adult companions: Familiar Adult: A caregiver or individual known to the child. Unfamiliar Adult: An adult not known to the child. Procedure: The walking distance will be 10 meters. The adult will wear a metronome in an earbud to ensure that they maintain the prescribed walking speed, which the child will be instructed to follow. Each child will experience all combinations of walking speeds and social interactions, allowing for a comprehensive assessment of how these factors influence gait parameters. Gait Parameters: The following parameters will be recorded during each walking session using video analysis software (Kinovea©): Stride length Step time Cadence Velocity Joint amplitudes

Walking Intervention with Varying Speeds and Social Interaction in Children with Autism Spectrum Dis

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study employs a single-group, quasi-experimental design, where 30 children aged 4 to 6 years with Autism Spectrum Disorder (ASD) participate in a structured walking intervention. The intervention consists of observing the children's gait parameters under varying conditions: walking at normal (120 bpm), slow (100 bpm), and fast (140 bpm) rhythms, while accompanied by either a familiar adult or an unfamiliar adult. Each child will walk a distance of 10 meters, with their gait parameters-such as stride length, step time, cadence, velocity, and joint amplitudes-measured using video analysis software (Kinovea©). This sequential approach enables the assessment of the impact of both speed and social interaction on gait dynamics in a controlled environment. The study aims to elucidate how these factors influence locomotion in children with ASD, providing insights for future therapeutic interventions and rehabilitation strategies.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 26, 2024

Study Start

May 1, 2024

Primary Completion

July 31, 2024

Study Completion

August 31, 2024

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Data Sensitivity: Given that the study focuses on a vulnerable population (children with Autism Spectrum Disorder), there are heightened concerns regarding the misuse or misinterpretation of the data.

Locations