Clinical trial NCT06659328: Influence of Rhythm and Interpersonal Relationship on Gait Parameters in Children with Autism Spectrum Disorder
Official title: Influence of Rhythm and Interpersonal Relationship on Gait Parameters in Children with Autism Spectrum Disorder: a Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism
stability
interpersonal relationship
gait patterns
proprioception
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cadence
timeFrame: Immediately before the intervention and immediately after the intervention on the same day
Secondary outcomes:
measure: Stride Length
timeFrame: Immediately before the intervention and immediately after the intervention on the same day
measure: Step Time: The duration of each step, measured in seconds
timeFrame: Immediately before the intervention and immediately after the intervention on the same day
measure: Velocity:
timeFrame: Immediately before the intervention and immediately after the intervention on the same day
measure: Joint Amplitudes
timeFrame: Immediately before the intervention and immediately after the intervention on the same day
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Europea de Madrid
Study officials:
References: