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

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• Autistic Disorder 1,344
• Autism Spectrum Disorder 1,727
• Child Development Disorders, Pervasive 457

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 30 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Lead sponsor

Creighton University is the lead sponsor of 126 studies on the registry; 4 are open to participants now.

Study arms

• Experimental
  Children with Autism Spectrum Disorders

  Children with autism spectrum disorder will receive a 6 week (once per week) hippotherapy protocol. During the hippotherapy session, the researchers will monitor the heart rate variability of the horse and the rider. Both horse and rider will wear an electrode strap around the upper thorax. Heart rate recordings will be started simultaneously at the beginning of the HPOT session. To assess movement coupling between the horse and rider, five tri-axial inertial sensors (OPAL, APDM, Inc, Portland, OR) will be used. The sensors will collect actively synchronized tri-axial accelerometer and gyroscope data. One inertial sensor will be placed dorsal at the rider's pelvis, one frontal at the top of the forehead, and one frontal at the top of the sternum. The sensors on the horse will be fixed on the back of the horse on the spine level between T8 and T10 and on the head.

  Behavioral: Hippotherapy

• Active comparator
  Children with typical development

  Children with autism spectrum disorder and with typical development will receive a 6 week (once per week) hippotherapy protocol. During the hippotherapy session, the researchers will monitor the heart rate variability of the horse and the rider. Both horse and rider will wear an electrode strap around the upper thorax. Heart rate recordings will be started simultaneously at the beginning of the HPOT session. To assess movement coupling between the horse and rider, five tri-axial inertial sensors (OPAL, APDM, Inc, Portland, OR) will be used. The sensors will collect actively synchronized tri-axial accelerometer and gyroscope data. One inertial sensor will be placed dorsal at the rider's pelvis, one frontal at the top of the forehead, and one frontal at the top of the sternum. The sensors on the horse will be fixed on the back of the horse on the spine level between T8 and T10 and on the head.

  Behavioral: Hippotherapy

Interventions

• BehavioralHippotherapy

  The hippotherapy involves occupational therapy while being on a horse.

Primary outcomes

1. Social Responsiveness Scale (SRS)

   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.

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

2. Postural Control

   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.

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

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

   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.

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

Secondary outcomes

1. Correlation Between Horse Temperament and Therapeutic Outcomes

   Correlation estimate between horse temperament and treatment effectiveness

   Time frame: from baseline to 6 weeks

2. Aberrant Behavior Checklist

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

   Time frame: Change from baseline to 6 weeks

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Jan 18, 2021
• Informed consent form · Jan 18, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No