Autism Spectrum DisorderNCT04772898
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
A study testing Hippotherapy in people with Autism Spectrum Disorder, run by Creighton University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Hippotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hearthland Equine Therapeutic Riding Academy
Gretna, Nebraska, 68028
About this study
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.
Read the 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
- Being tested
- Hippotherapy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HippotherapyBehavioural
The hippotherapy involves occupational therapy while being on a horse.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Hippotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: During week 1, week 3 and week 6 of the treatment sessions
Secondary outcomes (2)
Correlation Between Horse Temperament and Therapeutic Outcomes
Correlation estimate between horse temperament and treatment effectiveness
Measured: from baseline to 6 weeks
Aberrant Behavior Checklist
This is a questionnaire completed by the caregivers that assesses irritability, social withdrawal, stereotypic behavior, hyperactive/noncompliance, inappropriate speech
Measured: Change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start7 Sep 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anastasia Kyvelidou, Creighton University
- Investigators
- Anastasia Kyvelidou, PhD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772898
- Sponsor's protocol ID
- 5R03HD101115-02
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2021
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kyvelidou A, Godden E, Otte K, Smith K, Peck K, Adamiec M, Travis E, Almazloum M, Katsavelis D. Effectiveness of a 6-week occupational therapy program with hippotherapy on postural control and social behavior for children with autism spectrum disorder. Int J Dev Disabil. 2024 Jun 5;72(4):819-831. doi: 10.1080/20473869.2024.2363023. eCollection 2026.
PubMed 42205945
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04772898
- Acronym / sponsor ID
- 5R03HD101115-02
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Autism Spectrum Disorders | Experimental | Behavioral: HippotherapyChildren 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. |
| Children with typical development | Active comparator | Behavioral: HippotherapyChildren 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. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HippotherapyThe hippotherapy involves occupational therapy while being on a horse. | Behavioural | Children with Autism Spectrum Disorders, Children with typical development |
Primary outcome
Social Responsiveness Scale (SRS)
Time frame: Change from Pre (baseline) to Post (after completion of 6 weeks of intervention)
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.
Postural Control
Time frame: Change from Pre (baseline) to Post (6 weeks after hippotherapy intervention)
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.
Cross Sample Entropy Between the Heart Rate Sensors of the Horse and Rider
Time frame: 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.
2 secondary outcomes
Correlation Between Horse Temperament and Therapeutic Outcomes
Time frame: from baseline to 6 weeks
Aberrant Behavior Checklist
Time frame: Change from baseline to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42205945Kyvelidou A, Godden E, Otte K, Smith K, Peck K, Adamiec M, Travis E, Almazloum M, Katsavelis D. Effectiveness of a 6-week occupational therapy program with hippotherapy on postural control and social behavior for children with autism spectrum disorder. Int J Dev Disabil. 2024 Jun 5;72(4):819-831. doi: 10.1080/20473869.2024.2363023. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anastasia Kyvelidou, PhD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hippotherapy in people with Autism Spectrum Disorder, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Responsiveness Scale (SRS) (time frame: Change from Pre (baseline) to Post (after completion of 6 weeks of intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04772898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.