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

NCT04772898 | Completed Results

• 1 other identifier: 5R03HD101115-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

  During week 1, week 3 and week 6 of the treatment sessions

Secondary Outcomes (2)

• Correlation Between Horse Temperament and Therapeutic Outcomes

  from baseline to 6 weeks

• Aberrant Behavior Checklist

  Change from baseline to 6 weeks

Study Arms (2)

Children with Autism Spectrum Disorders

EXPERIMENTAL

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

Children with typical development

ACTIVE COMPARATOR

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

Hippotherapy BEHAVIORAL

The hippotherapy involves occupational therapy while being on a horse.

Children with Autism Spectrum Disorders; Children with typical development

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Hearthland Equine Therapeutic Riding Academy

Gretna, Nebraska, 68028, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Animal Assisted Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Anastasia Kyvelidou
• Organization: Creighton University

aky61380@creighton.edu

4022805749

Study Officials

• Anastasia Kyvelidou, PhD

  Creighton University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 26, 2021
• Study Start: September 7, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)