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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772898
• Other study ID #: 5R03HD101115-02
• Status: Completed
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2024
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

For the children with Autism Spectrum Disorders:

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.

The inclusion criteria for the TD children will be:

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• Hippotherapy
The hippotherapy involves occupational therapy while being on a horse.

Locations

Country	Name	City	State
United States	Hearthland Equine Therapeutic Riding Academy	Gretna	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Correlation Between Horse Temperament and Therapeutic Outcomes	Correlation estimate between horse temperament and treatment effectiveness	from baseline to 6 weeks
Secondary	Aberrant Behavior Checklist	This is a questionnaire completed by the caregivers that assesses irritability, social withdrawal, stereotypic behavior, hyperactive/noncompliance, inappropriate speech	Change from baseline to 6 weeks