Autism Spectrum DisorderNCT06659328
Influence of Rhythm and Interpersonal Relationship on Gait Parameters in Children With Autism Spectrum Disorder
A study testing Structured Walking Intervention for Children with Autism Spectrum Disorder. in people with Autism Spectrum Disorder, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
Autism Spectrum Disorder (ASD) is associated with differences in social communication, motor coordination, interpersonal synchronization, and gait. This randomized crossover study examined the influence of walking pace and social familiarity on gait parameters in 30 children aged 4-6 years with ASD. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Structured Walking Intervention for Children with Autism Spectrum Disorder.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2024to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Rhythm and Interpersonal Relationship on Gait Parameters in Children With Autism Spectrum Disorder: A Controlled Intervention Study
Autism Spectrum Disorder (ASD) is associated with differences in social communication, motor coordination, interpersonal synchronization, and gait. This randomized crossover study examined the influence of walking pace and social familiarity on gait parameters in 30 children aged 4-6 years with ASD. Participants completed 10-metre walking trials at three pacing conditions (100, 120, and 140 beats per minute) while walking alongside either their mother or an unfamiliar researcher. The order of the two social conditions was randomized, and all participants completed both conditions. Spatiotemporal and lower-limb kinematic gait parameters were assessed from video recordings.
Read the detailed description
Study Design:
This randomized crossover interventional study assessed the influence of walking pace and social familiarity on gait parameters in children diagnosed with Autism Spectrum Disorder (ASD). The study included 30 children aged 4-6 years with ASD level I or II who were able to walk independently without assistive devices. Participants were recruited from Fundación AMÁS, an early intervention centre.
Participants were randomly assigned to one of two sequences. Fifteen participants completed the mother condition first, followed by the unfamiliar-researcher condition, and fifteen completed the unfamiliar-researcher condition first, followed by the mother condition. All participants therefore completed both social walking conditions. Randomization applied to the order of the social conditions.
Walking Procedure:
Participants completed walking trials under three pacing conditions: 100, 120, and 140 beats per minute. Under each pacing condition, the child walked alongside either their mother or an unfamiliar researcher, who was the same person for all participants.
The accompanying adult received the pacing cue through an earpiece, while the child received no direct auditory cue and was instructed to walk alongside the adult without holding hands. Each child completed three repetitions of a 10-metre walk in each condition.
Video recordings were obtained from a lateral view under standardized recording conditions. Only the central 2 metres of the final repetition were analysed to exclude the acceleration and deceleration phases. Gait parameters were assessed from the recordings using Kinovea® software.
Outcome Measures:
The assessed outcomes were gait speed, cadence, stride length, stride time, step time, and hip, knee, and ankle joint angles at eight predefined events and phases of the gait cycle: initial contact, loading response, mid-stance, terminal stance, pre-swing, initial swing, mid-swing, and terminal swing.
Study Population:
Eligible participants were children aged 4-6 years with a clinical diagnosis of ASD level I or II who attended regular therapy sessions at Fundación AMÁS and were able to walk independently. Children with associated syndromes or recent interventions affecting the lower limbs were excluded.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Structured Walking Intervention for Children with Autism Spectrum Disorder.
- Keywords
- autism, stability, interpersonal relationship, gait patterns, proprioception
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Walking Intervention for Children with Autism Spectrum Disorder.Procedure or surgery
Participants completed 10-metre walking trials under three pacing conditions: 100, 120, and 140 beats per minute. Under each pacing condition, participants walked alongside either their mother or an unfamiliar researcher, who was the same person for all participants. The accompanying adult received the pacing cue through an earpiece, while the child received no direct auditory cue and was instructed to walk alongside the adult without holding hands. All participants completed both social conditions, with the order of the mother and unfamiliar-researcher conditions determined by random allocation. Gait speed, cadence, stride length, stride time, step time, and hip, knee, and ankle joint angles were assessed from video recordings using Kinovea® software.
| Study group | Role | What they receive |
|---|---|---|
| Mother-first sequence | Experimental | Fifteen participants first completed the walking trials alongside their mother and subsequently crossed over to complete the trials alongside the unfamiliar researcher. Participants performed the walking task under the three pacing conditions (100, 120, and 140 bpm). Receives: Procedure: Structured Walking Intervention for Children with Autism Spectrum Disorder. |
| Unfamiliar-researcher-first sequence | Experimental | Fifteen participants first completed the walking trials alongside the unfamiliar researcher and subsequently crossed over to complete the trials alongside their mother. Participants performed the walking task under the three pacing conditions (100, 120, and 140 bpm). Receives: Procedure: Structured Walking Intervention for Children with Autism Spectrum Disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cadence
The number of steps taken per minute.
Measured: During each walking condition within a single assessment session.
Secondary outcomes (4)
Step Length
The distance covered in a single step, measured in meters
Measured: During each walking condition within a single assessment session.
Step Time: The duration of each step, measured in seconds
The duration of each step, measured in seconds
Measured: During each walking condition within a single assessment session.
Velocity:
The speed of walking, measured in meters per second.
Measured: During each walking condition within a single assessment session.
Joint Amplitudes
The angles at which the hip, knee, and ankle joints move during each phase of the gait cycle, assessed in degrees
Measured: During each walking condition within a single assessment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Feb 2024
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study used a randomized crossover design involving 30 children aged 4-6 years with Autism Spectrum Disorder (ASD). All participants completed walking trials at three pacing conditions (100, 120, and 140 beats per minute) while walking alongside either their mother or an unfamiliar researcher. Participants were randomized to begin with either the mother condition or the unfamiliar-researcher condition and subsequently crossed over to the alternative social condition. Thus, all participants completed both social conditions. Gait parameters, including gait speed, cadence, stride length, stride time, step time, and hip, knee, and ankle joint angles, were assessed from video recordings using Kinovea® software.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Estrada Barranco, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659328
- Sponsor's protocol ID
- ASD intervention
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Rhythm and Interpersonal Relationship on Gait Parameters in Children With Autism Spectrum Disorder: A Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT06659328
- Acronym / sponsor ID
- ASD intervention
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, stability, interpersonal relationship, gait patterns, proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autism Spectrum Disorder (ASD) is associated with differences in social communication, motor coordination, interpersonal synchronization, and gait. This randomized crossover study examined the influence of walking pace and social familiarity on gait parameters in 30 children aged 4-6 years with ASD. Participants completed 10-metre walking trials at three pacing conditions (100, 120, and 140 beats per minute) while walking alongside either their mother or an unfamiliar researcher. The order of the two social conditions was randomized, and all participants completed both conditions. Spatiotemporal and lower-limb kinematic gait parameters were assessed from video recordings.
Detailed description
Study Design:
This randomized crossover interventional study assessed the influence of walking pace and social familiarity on gait parameters in children diagnosed with Autism Spectrum Disorder (ASD). The study included 30 children aged 4-6 years with ASD level I or II who were able to walk independently without assistive devices. Participants were recruited from Fundación AMÁS, an early intervention centre.
Participants were randomly assigned to one of two sequences. Fifteen participants completed the mother condition first, followed by the unfamiliar-researcher condition, and fifteen completed the unfamiliar-researcher condition first, followed by the mother condition. All participants therefore completed both social walking conditions. Randomization applied to the order of the social conditions.
Walking Procedure:
Participants completed walking trials under three pacing conditions: 100, 120, and 140 beats per minute. Under each pacing condition, the child walked alongside either their mother or an unfamiliar researcher, who was the same person for all participants.
The accompanying adult received the pacing cue through an earpiece, while the child received no direct auditory cue and was instructed to walk alongside the adult without holding hands. Each child completed three repetitions of a 10-metre walk in each condition.
Video recordings were obtained from a lateral view under standardized recording conditions. Only the central 2 metres of the final repetition were analysed to exclude the acceleration and deceleration phases. Gait parameters were assessed from the recordings using Kinovea® software.
Outcome Measures:
The assessed outcomes were gait speed, cadence, stride length, stride time, step time, and hip, knee, and ankle joint angles at eight predefined events and phases of the gait cycle: initial contact, loading response, mid-stance, terminal stance, pre-swing, initial swing, mid-swing, and terminal swing.
Study Population:
Eligible participants were children aged 4-6 years with a clinical diagnosis of ASD level I or II who attended regular therapy sessions at Fundación AMÁS and were able to walk independently. Children with associated syndromes or recent interventions affecting the lower limbs were excluded.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study used a randomized crossover design involving 30 children aged 4-6 years with Autism Spectrum Disorder (ASD). All participants completed walking trials at three pacing conditions (100, 120, and 140 beats per minute) while walking alongside either their mother or an unfamiliar researcher. Participants were randomized to begin with either the mother condition or the unfamiliar-researcher condition and subsequently crossed over to the alternative social condition. Thus, all participants completed both social conditions. Gait parameters, including gait speed, cadence, stride length, stride time, step time, and hip, knee, and ankle joint angles, were assessed from video recordings using Kinovea® software.
| Arm | Type | Receives |
|---|---|---|
| Mother-first sequence | Experimental | Procedure: Structured Walking Intervention for Children with Autism Spectrum Disorder.Fifteen participants first completed the walking trials alongside their mother and subsequently crossed over to complete the trials alongside the unfamiliar researcher. Participants performed the walking task under the three pacing conditions (100, 120, and 140 bpm). |
| Unfamiliar-researcher-first sequence | Experimental | Procedure: Structured Walking Intervention for Children with Autism Spectrum Disorder.Fifteen participants first completed the walking trials alongside the unfamiliar researcher and subsequently crossed over to complete the trials alongside their mother. Participants performed the walking task under the three pacing conditions (100, 120, and 140 bpm). |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Walking Intervention for Children with Autism Spectrum Disorder.Participants completed 10-metre walking trials under three pacing conditions: 100, 120, and 140 beats per minute. Under each pacing condition, participants walked alongside either their mother or an unfamiliar researcher, who was the same person for all participants. The accompanying adult received the pacing cue through an earpiece, while the child received no direct auditory cue and was instructed to walk alongside the adult without holding hands. All participants completed both social conditions, with the order of the mother and unfamiliar-researcher conditions determined by random allocation. Gait speed, cadence, stride length, stride time, step time, and hip, knee, and ankle joint angles were assessed from video recordings using Kinovea® software. | Procedure or surgery | Mother-first sequence, Unfamiliar-researcher-first sequence |
Primary outcome
Cadence
Time frame: During each walking condition within a single assessment session.
The number of steps taken per minute.
4 secondary outcomes
Step Length
Time frame: During each walking condition within a single assessment session.
Step Time: The duration of each step, measured in seconds
Time frame: During each walking condition within a single assessment session.
Velocity:
Time frame: During each walking condition within a single assessment session.
Joint Amplitudes
Time frame: During each walking condition within a single assessment session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Walking Intervention for Children with Autism Spectrum Disorder. in people with Autism Spectrum Disorder, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cadence (time frame: During each walking condition within a single assessment session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.