- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06659328
Influence of Rhythm and Interpersonal Relationship on Gait Parameters in Children with Autism Spectrum Disorder
Influence of Rhythm and Interpersonal Relationship on Gait Parameters in Children with Autism Spectrum Disorder: a Controlled Intervention Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain, 28670
- Universidad Europea de Madrid
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Walking Intervention with Varying Speeds and Social Interaction in Children with Autism Spectrum Dis
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 |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cadence
Time Frame: Immediately before the intervention and immediately after the intervention on the same day
|
The number of steps taken per minute.
|
Immediately before the intervention and immediately after the intervention on the same day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Immediately before the intervention and immediately after the intervention on the same day
|
|
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
|
Immediately before the intervention and immediately after the intervention on the same day
|
|
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.
|
Immediately before the intervention and immediately after the intervention on the same day
|
|
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
|
Immediately before the intervention and immediately after the intervention on the same day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASD intervention
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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