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Completed

NCT Number: NCT06659328

Influence of Rhythm and Interpersonal Relationship on Gait Parameters in Children with Autism Spectrum Disorder

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.

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea de Madrid

Madrid, 28670, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Structured Walking Intervention for Children with Autism Spectrum Disorder

Procedure

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

Primary outcomes

  1. 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

  1. Stride Length

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

    The distance covered in a single step, measured in meters

  2. Step Time: The duration of each step, measured in seconds

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

    The duration of each step, measured in seconds

  3. Velocity:

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

    The speed of walking, measured in meters per second.

  4. Joint Amplitudes

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

    The angles at which the hip, knee, and ankle joints move during each phase of the gait cycle, assessed in degrees

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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