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

NCT ID: NCT04772898

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-07
• Study Completion Date: 2022-07-31

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.

Detailed Description

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hippotherapy

Intervention Type: BEHAVIORAL

The hippotherapy involves occupational therapy while being on a horse.

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.

Group Type: ACTIVE_COMPARATOR

Hippotherapy

Intervention Type: BEHAVIORAL

The hippotherapy involves occupational therapy while being on a horse.

Interventions

Hippotherapy

The hippotherapy involves occupational therapy while being on a horse.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. diagnosis of ASD based upon the Autism Diagnostic Observation Schedule and parent interview,

2. medical approval for participation in the HPOT activity,

3. no other medical or psychiatric diagnoses besides ASD

4. tolerate helmet on head and attachments of the movement and heart rate sensors.

1. no diagnosis or family history of ASD

2. no other neurodevelopmental or musculoskeletal disorder

3. tolerate helmet on head and attachments of the movement and heart rate sensors.

4. medical approval for participation in the HPOT activity,

Exclusion Criteria

1. under 5 years of age or over 10 years of age

2. has a serious comorbid medical diagnosis

3. major vision or hearing impairments

4. severe behavioral problems

5. an orthopedic or genetic diagnosis

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Anastasia Kyvelidou

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anastasia Kyvelidou, PhD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

Hearthland Equine Therapeutic Riding Academy

Gretna, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R03HD101115-02

Identifier Type: NIH

Identifier Source: org_study_id

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