Trial Outcomes & Findings for Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder (NCT NCT04772898)

Last Updated: 2024-03-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

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

Results posted on

2024-03-18

Participant Flow

No significant events

Participant milestones

Participant milestones
Measure	Children With Autism Spectrum Disorder 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. Hippotherapy: The hippotherapy involves occupational therapy while being on a horse.	Children With Typical Development Children 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. Hippotherapy: The hippotherapy involves occupational therapy while being on a horse.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Children With Autism Spectrum Disorder 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. Hippotherapy: The hippotherapy involves occupational therapy while being on a horse.	Children With Typical Development Children 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. Hippotherapy: The hippotherapy involves occupational therapy while being on a horse.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

One child from the typical development group dropped out, so we did not include them in the analysis

Baseline characteristics by cohort

PRIMARY outcome

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

Population: Children with typical development and diagnosed with ASD based on the inclusion and exclusion criteria.

Outcome measures

Outcome measures
Measure	Children With Typical Development n=14 Participants Children 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. Hippotherapy: The hippotherapy involves occupational therapy while being on a horse.	Children With Autism Spectrum Disorder n=15 Participants 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. Hippotherapy: The hippotherapy involves occupational therapy while being on a horse.
Social Responsiveness Scale (SRS) Pre	16.5 Points Standard Deviation 12.4	89.06 Points Standard Deviation 27.3
Social Responsiveness Scale (SRS) Post	14.5 Points Standard Deviation 12.3	79.8 Points Standard Deviation 29.5

PRIMARY outcome

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

Population: The standing postural control protocol required children to be able to stand with eyes open and closed for 10 sec without moving their legs. This was possible only for 8 children with the autism spectrum disorder group and all of the children in the typical development group.

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.

Outcome measures

Outcome measures
Measure	Children With Typical Development n=14 Participants Children 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. Hippotherapy: The hippotherapy involves occupational therapy while being on a horse.	Children With Autism Spectrum Disorder n=8 Participants 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. Hippotherapy: The hippotherapy involves occupational therapy while being on a horse.
Postural Control Post	0.53 Hz Standard Deviation 0.21	0.57 Hz Standard Deviation 0.15
Postural Control Pre	0.525 Hz Standard Deviation 0.17	0.48 Hz Standard Deviation 0.18

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Children With Typical Development n=15 Participants Children 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. Hippotherapy: The hippotherapy involves occupational therapy while being on a horse.	Children With Autism Spectrum Disorder n=14 Participants 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. Hippotherapy: The hippotherapy involves occupational therapy while being on a horse.
Cross Sample Entropy Between the Heart Rate Sensors of the Horse and Rider 1st session	0.685 Unitless Standard Deviation 0.09	0.512 Unitless Standard Deviation 0.25
Cross Sample Entropy Between the Heart Rate Sensors of the Horse and Rider 3rd session	0.644 Unitless Standard Deviation 0.18	0.578 Unitless Standard Deviation 0.16
Cross Sample Entropy Between the Heart Rate Sensors of the Horse and Rider 6th session	0.681 Unitless Standard Deviation 0.18	0.564 Unitless Standard Deviation 0.18

SECONDARY outcome

Timeframe: from baseline to 6 weeks

Correlation estimate between horse temperament and treatment effectiveness

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 6 weeks

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

Outcome measures

Outcome data not reported

Adverse Events

Children With Typical Development

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Children With Autism Spectrum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anastasia Kyvelidou

Creighton University

Phone: 4022805749

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Children With Autism Spectrum Disorders n=15 Participants 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. Hippotherapy: The hippotherapy involves occupational therapy while being on a horse.	Children With Typical Development n=15 Participants Children 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. Hippotherapy: The hippotherapy involves occupational therapy while being on a horse.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Continuous	8 years STANDARD_DEVIATION 1.97 • n=15 Participants	7.8 years STANDARD_DEVIATION 1.44 • n=15 Participants	7.9 years STANDARD_DEVIATION 1.715 • n=30 Participants
Sex: Female, Male Female	4 Participants n=15 Participants	9 Participants n=15 Participants	13 Participants n=30 Participants
Sex: Female, Male Male	11 Participants n=15 Participants	6 Participants n=15 Participants	17 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=15 Participants	1 Participants n=15 Participants	2 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=15 Participants	14 Participants n=15 Participants	28 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Asian	1 Participants n=15 Participants	0 Participants n=15 Participants	1 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Race (NIH/OMB) White	13 Participants n=15 Participants	15 Participants n=15 Participants	28 Participants n=30 Participants
Race (NIH/OMB) More than one race	1 Participants n=15 Participants	0 Participants n=15 Participants	1 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Social Responsiveness Scale (SRS)	16.5 Points STANDARD_DEVIATION 12.4 • n=15 Participants • One child from the typical development group dropped out, so we did not include them in the analysis	89.06 Points STANDARD_DEVIATION 27.3 • n=14 Participants • One child from the typical development group dropped out, so we did not include them in the analysis	52.78 Points STANDARD_DEVIATION 19.85 • n=29 Participants • One child from the typical development group dropped out, so we did not include them in the analysis