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Completed

NCT Number: NCT04772898

Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder

The prevalence of autism spectrum disorders (ASD) has increased dramatically in the last decade. The increasing occurrence of ASD creates an imperative need to test the effectiveness and efficacy mechanisms of appropriate interventions. Hippotherapy (HPOT) is a treatment option that has been show beneficial for children with ASD as well as other children with developmental disorders. The current projects focuses on understanding the mechanisms of HPOT efficacy and evaluating a short-term HPOT program for children with ASD.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hearthland Equine Therapeutic Riding Academy

Gretna, Nebraska, 68028, United States

About this study

The incidence of autism spectrum disorders (ASD) has increased dramatically in the last decade. The latest report from the Centers for Disease Control and Prevention state that 1 in 59 children are being diagnosed with ASD and it is four times more prevalent in boys than girls. Common treatments for children with ASD are applied behavioral therapy, occupational and speech therapy, which are used solely or in combination. Hippotherapy (HPOT) is another treatment option that has been shown to positively impact various aspects of behavior. This pilot project aims to determine the effects of a 6-week HPOT program on movement and social behavior of children with ASD and to investigate the underlying mechanisms of why HPOT is successful for ASD through the coupling of physiological and temperamental responses between horse and rider. The approach involves examining these skills pre, during, and post HPOT intervention in children diagnosed with ASD. A group of aged matched children with typical development will serve as the control group. Innovative measures of physiological coupling and temperament between horse and rider as well as objective and quantitative measures of movement and social behavior and caregiver perception will be collected. The investigators anticipate that following completion of the proposed study, they will provide the necessary foundation to understand the mechanisms of HPOT, and thus provide a new framework to test clinical trials of HPOT and human-animal interaction, and ultimately improve the lives of those diagnosed with ASD and their families.

Who can participate

Healthy volunteers accepted: Yes

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

For the children with Autism Spectrum Disorders:

Inclusion criteria

  • diagnosis of ASD based upon the Autism Diagnostic Observation Schedule and parent interview,
  • medical approval for participation in the HPOT activity,
  • no other medical or psychiatric diagnoses besides ASD
  • tolerate helmet on head and attachments of the movement and heart rate sensors.

The inclusion criteria for the TD children will be:

  • no diagnosis or family history of ASD
  • no other neurodevelopmental or musculoskeletal disorder
  • tolerate helmet on head and attachments of the movement and heart rate sensors.
  • medical approval for participation in the HPOT activity,

Exclusion criteria

  • under 5 years of age or over 10 years of age
  • has a serious comorbid medical diagnosis
  • major vision or hearing impairments
  • severe behavioral problems
  • an orthopedic or genetic diagnosis

Treatment and study plan

hippotherapy

Behavioral

The hippotherapy involves occupational therapy while being on a horse.

Primary outcomes

  1. Social Responsiveness Scale (SRS)

    Time frame: Change from Pre (baseline) to Post (after completion of 6 weeks of intervention)

    The SRS provides a clear picture of a child's social impairments, assessing social awareness, social information processing, capacity for reciprocal social communication, social anxiety/avoidance, and autistic preoccupations and traits. The SRS is a 65-item rating scale that measures autism traits over the previous 6 months in children and adolescents aged 4-18 years. Each item is scaled from 0 (never true) to 3 (almost always true), generating a total score ranging from 0 to 195.The total score of the SRS is reported below. Higher values represent worse outcome.

  2. Postural Control

    Time frame: Change from Pre (baseline) to Post (6 weeks after hippotherapy intervention)

    Postural control assessment with a force platform with eyes open and eyes closed. Differences were more prevalent with eyes closed. We report a specific measure of postural control which is median frequency while standing with eyes closed. Median frequency can have a very wide range of values, but increased values of median frequency suggest faster postural control adaptations.

  3. Cross Sample Entropy Between the Heart Rate Sensors of the Horse and Rider

    Time frame: During week 1, week 3 and week 6 of the treatment sessions

    Heart rate monitors were placed around the upper thorax of both the rider and horse and simultaneously began collecting data at the beginning of each session. Data was collected at the first, third, and sixth sessions of the intervention. We used the heart rate signals of the horse and rider to calculate the Cross approximate entropy. Cross-ApEn quantifies the regularity of patterns in a pair of related time series and is indicative of the dimensionality of control of the two signals. The calculation of Cross-ApEn is similar to approximate entropy with the exception that successive two-point vectors of one signal are compared with current and previous two-point vectors of another signal. Larger Cross-ApEn values indicate greater joint signal asynchrony while lower Cross-ApEn values indicate greater joint signal synchrony.For details on calculation of Cross-ApEn please refer to: Pincus S, Singer BH. Randomness and degrees of irregularity. Proc Natl Acad Sci USA. 1996; 93: 2083-2088.

Secondary outcomes

  1. Correlation Between Horse Temperament and Therapeutic Outcomes

    Time frame: from baseline to 6 weeks

    Correlation estimate between horse temperament and treatment effectiveness

  2. Aberrant Behavior Checklist

    Time frame: Change from baseline to 6 weeks

    This is a questionnaire completed by the caregivers that assesses irritability, social withdrawal, stereotypic behavior, hyperactive/noncompliance, inappropriate speech

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2021
Registry last updated
Mar 18, 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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