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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hippotherapy
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Autism Spectrum Disorder

Eligibility Criteria

5 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hearthland Equine Therapeutic Riding Academy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hippotherapy

Arm Description

Both 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.

Outcomes

Primary Outcome Measures

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.
Postural control, center of pressure measures (range, root mean square, sway path, sample entropy)
Postural control assessment with a force platform with eyes open and eyes closed
Coherence and Cross Sample Entropy between the movement sensors and heart rate sensors of the horse and rider
We will use the movement sensors and heart rate sensors to estimate the coupling between the horse and the rider.

Secondary Outcome Measures

Correlation between horse temperament and therapeutic outcomes
Correlation estimate between horse temperament and treatment effectiveness
Aberrant Behavior Checklist
This is a questionnaire completed by the caregivers that assesses irritability, social withdrawal, stereotypic behavior, hyperactive/noncompliance, inappropriate speech

Full Information

First Posted
February 21, 2021
Last Updated
February 27, 2023
Sponsor
Creighton University
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1. Study Identification

Unique Protocol Identification Number
NCT04772898
Brief Title
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
Official Title
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Creighton University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hippotherapy
Arm Type
Experimental
Arm Description
Both 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.
Intervention Type
Behavioral
Intervention Name(s)
Hippotherapy
Intervention Description
The hippotherapy involves occupational therapy while being on a horse.
Primary Outcome Measure Information:
Title
Social Responsiveness Scale (SRS)
Description
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.
Time Frame
Change from baseline to 6 weeks
Title
Postural control, center of pressure measures (range, root mean square, sway path, sample entropy)
Description
Postural control assessment with a force platform with eyes open and eyes closed
Time Frame
Change from baseline to 6 weeks after the hippotherarpy
Title
Coherence and Cross Sample Entropy between the movement sensors and heart rate sensors of the horse and rider
Description
We will use the movement sensors and heart rate sensors to estimate the coupling between the horse and the rider.
Time Frame
During week 1, week 3 and week 6 of the treatment sessions
Secondary Outcome Measure Information:
Title
Correlation between horse temperament and therapeutic outcomes
Description
Correlation estimate between horse temperament and treatment effectiveness
Time Frame
from baseline to 6 weeks
Title
Aberrant Behavior Checklist
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasia Kyvelidou, PhD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hearthland Equine Therapeutic Riding Academy
City
Gretna
State/Province
Nebraska
ZIP/Postal Code
68028
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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