Autism Spectrum DisorderNCT06530680
Upper Extremity Function Before and After Hippotherapy in Children With Autism Spectrum Disorder and/or Cerebral Palsy
A study testing Hippotherapy in people with Autism Spectrum Disorder and Cerebral Palsy, run by Ohio State University at 1 site in United States.
Trial summary
The goal of this feasibility trial is to learn if hippotherapy and physical therapy in the equine environment can be used to improve upper extremity function in children with cerebral palsy or autism spectrum disorder who present with motor delay or impairment in the upper extremities. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder, Cerebral Palsy
- 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 3 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 6 to 17
- Diagnosis of Cerebral Palsy with Gross Motor Functional Classification System (GMFCS) Level I, II, or III with upper extremity affected Cerebral Palsy and/or Autism Spectrum Disorder
- Able to follow simple verbal instructions in English
- Able to tolerate sitting on a horse continuously for 30 minutes
Who cannot join
- Fear of or aversion to horses
- Weight over 200 lb
- Lacking independent head control (GMFCS level IV and V)
- Both parents unable to speak and read English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Upper Extremity Function, Activity, Participation, and Engagement Before and After Hippotherapy in Children With Autism Spectrum Disorder and/or Cerebral Palsy
The goal of this feasibility trial is to learn if hippotherapy and physical therapy in the equine environment can be used to improve upper extremity function in children with cerebral palsy or autism spectrum disorder who present with motor delay or impairment in the upper extremities. The main questions it aims to answer are:
Can the upper extremity-focused treatment using hippotherapy and the equine environment be delivered to fidelity?
Read more
Is the treatment acceptable to participants and therapists?
Is the randomized-controlled trial protocol feasible to scale to a larger study, including recruitment and retention rates and suitability of selected outcome measures?
If there is a comparison group: Researchers will compare participants receiving treatment to a waitlist control to see if participants are retained in the control group and if differences are detected between the control and treatment groups on selected outcome measures.
Read the detailed description
Intervention. Participants will receive 4 weeks of hippotherapy, 4 × 1-hour sessions per week, for a total of 16 hours of intervention. If the participants miss a session, make-up sessions will be offered, scheduled, and tracked.51
Hippotherapy: The hippotherapy intervention will be delivered at Dreams on Horseback in central Ohio using Professional Association of Therapeutic Horsemanship (PATH) Intl. standards. Participants will be mounted on a horse for at least 30 minutes of the 1-hour session. Activities for the remaining time include grooming and tacking of the horses, mounting, and dismounting. A herd of 9 horses will be used for hippotherapy sessions. There will be 2 volunteers assisting with every session: one to lead the horse, and one to walk alongside the participant opposite the treating therapist. Dreams on Horseback has a part-time Volunteer Coordinator who currently schedules 154 volunteers for 22 hours of equine-assisted activities per week (Monday - Saturday). Activities will include various positions on the horse such as sitting and quadruped (weight bearing through the upper extremities and knees), as well as reaching and throwing, controlling the horse with the reins, and riding the horse at a walk and a trot as is suggested by PATH Intl. Standards. Using the observation protocol in the preliminary data section, one researcher will video record one hippotherapy session each week and document the therapeutic activities performed. A second researcher will score 20% of the sessions to assure reliability of >90%. Categories expected based on preliminary data are transitions, ground poles, directional changes, reaches outside of base of support, reaches, weight bearing through upper extremities, using reins, holding upper extremities off of the horse, position on the horse (with or without stirrups, standing, sitting, posting), and kicking/squeezing the horse with legs. This analysis will allow the investigators to quantify the dose of hippotherapy, focus on the impact of therapeutic targets to the upper extremities, and allow the investigators to evaluate adherence to the hippotherapy protocol.
Treating Therapists: All treating therapists will be licensed PTs and will have completed at least the AHA Level I Hippotherapy Treatment Principles.
Since the goal of pilot studies is not to test efficacy, no inferential statistics are proposed. The investigators will analyze questions pertaining to 1) the recruitment success of children with CP+ASD ages 5-15; 2) whether participants adhere to what they are asked to do during the pilot RCT; and 3) if the treatment can be successfully delivered per protocol. The investigators will describe the number of potential participants screened per month; the number enrolled per month; the average time delay from screening to enrollment; and the average time to enroll enough participants for 2 groups. Treatment-specific retention and attrition rates for hippotherapy, including the reasons for dropouts, and treatment-specific fidelity rates, including a measure of dose of hippotherapy and upper extremity activities, will be described.
- Conditions
- Autism Spectrum Disorder, Cerebral Palsy
- Being tested
- Hippotherapy
- Medical subject headings
- Autism Spectrum Disorder, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HippotherapyBehavioural
Two 1-hour sessions of hippotherapy for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy incorporating hippotherapy and the equine environment | Experimental | Four 1 hour Hippotherapy treatments per week for four weeks. Receives: Behavioral: Hippotherapy |
| Waitlist Control | No intervention | A waitlist control that will receive hippotherapy intervention (four 1 hour Hippotherapy treatments per week for four weeks.) Four weeks later than the 'Physical therapy incorporating hippotherapy and the equine environment' Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach-and grasp protocol
Reach-and-grasp protocol: Participants were recorded while performing a reach-to-drink task. For each trial, participants were instructed: "Reach for the bottle, pick it up, pretend to take a drink, return the bottle to the marked position on the table, and return your hand to the start position. Do this twice." Movement of the upper extremities was recorded from reflective markers on the hands, wrists, elbows, shoulders, and sternum by a 10-camera VICON Motion Capture system at 120 Hz and filtered at 4 Hz with a low-pass Butterworth filter.
Measured: 1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period.
PEM-CY
Participation and Environment Measure for Children and Youth; higher scores mean better; participation scores range 0-7, involvement scores range 1-5.
Measured: 1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period
PRIME-O
Pediatric Rehabilitation Intervention Measure of Engagement - Observation; higher scores = more engaged; score range = 0-40 (0-4 per item)
Measured: 1 time per week during the 4-week intervention period
PRIME-SP
Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider; not scaled
Measured: 1 time per week during the 4-week intervention period
Enjoy
Self-report measure of enjoyment of an activity. The scale has 25 statements that respondents rate on a 7-point Likert scale the degree to which they agree or disagree with each statement. There are 5 sections of the measure that cover different components of enjoyment: pleasure, relatedness, competence, challenge/improvement, and engagement. higher scores = more enjoyment; scores range 1-7 per item.
Measured: 1 time per week during the 4-week intervention period
VABS
Vineland Adaptive Behavior Scale 2nd Edition; high scores mean better; Adaptive Behavior Composite standard score range: 20-160.
Measured: 1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period
CAPE/PAC
Child Assessment of Participation and Enjoyment / Preference for Activities in Children; higher scores mean better; score range CAPE = 55-275 (1-5 per item), PAC = 55-165 (1-3 per item)
Measured: 1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start14 Jun 2021
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital, University of Montana
- Responsible party
- Principal investigator, Jill Heathcock, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530680
- Sponsor's protocol ID
- 2020B0434
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Extremity Function, Activity, Participation, and Engagement Before and After Hippotherapy in Children With Autism Spectrum Disorder and/or Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06530680
- Acronym / sponsor ID
- 2020B0434
- Conditions
- Autism Spectrum Disorder, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital, University of Montana
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this feasibility trial is to learn if hippotherapy and physical therapy in the equine environment can be used to improve upper extremity function in children with cerebral palsy or autism spectrum disorder who present with motor delay or impairment in the upper extremities. The main questions it aims to answer are:
Can the upper extremity-focused treatment using hippotherapy and the equine environment be delivered to fidelity?
Is the treatment acceptable to participants and therapists?
Is the randomized-controlled trial protocol feasible to scale to a larger study, including recruitment and retention rates and suitability of selected outcome measures?
If there is a comparison group: Researchers will compare participants receiving treatment to a waitlist control to see if participants are retained in the control group and if differences are detected between the control and treatment groups on selected outcome measures.
Detailed description
Intervention. Participants will receive 4 weeks of hippotherapy, 4 × 1-hour sessions per week, for a total of 16 hours of intervention. If the participants miss a session, make-up sessions will be offered, scheduled, and tracked.51
Hippotherapy: The hippotherapy intervention will be delivered at Dreams on Horseback in central Ohio using Professional Association of Therapeutic Horsemanship (PATH) Intl. standards. Participants will be mounted on a horse for at least 30 minutes of the 1-hour session. Activities for the remaining time include grooming and tacking of the horses, mounting, and dismounting. A herd of 9 horses will be used for hippotherapy sessions. There will be 2 volunteers assisting with every session: one to lead the horse, and one to walk alongside the participant opposite the treating therapist. Dreams on Horseback has a part-time Volunteer Coordinator who currently schedules 154 volunteers for 22 hours of equine-assisted activities per week (Monday - Saturday). Activities will include various positions on the horse such as sitting and quadruped (weight bearing through the upper extremities and knees), as well as reaching and throwing, controlling the horse with the reins, and riding the horse at a walk and a trot as is suggested by PATH Intl. Standards. Using the observation protocol in the preliminary data section, one researcher will video record one hippotherapy session each week and document the therapeutic activities performed. A second researcher will score 20% of the sessions to assure reliability of >90%. Categories expected based on preliminary data are transitions, ground poles, directional changes, reaches outside of base of support, reaches, weight bearing through upper extremities, using reins, holding upper extremities off of the horse, position on the horse (with or without stirrups, standing, sitting, posting), and kicking/squeezing the horse with legs. This analysis will allow the investigators to quantify the dose of hippotherapy, focus on the impact of therapeutic targets to the upper extremities, and allow the investigators to evaluate adherence to the hippotherapy protocol.
Treating Therapists: All treating therapists will be licensed PTs and will have completed at least the AHA Level I Hippotherapy Treatment Principles.
Since the goal of pilot studies is not to test efficacy, no inferential statistics are proposed. The investigators will analyze questions pertaining to 1) the recruitment success of children with CP+ASD ages 5-15; 2) whether participants adhere to what they are asked to do during the pilot RCT; and 3) if the treatment can be successfully delivered per protocol. The investigators will describe the number of potential participants screened per month; the number enrolled per month; the average time delay from screening to enrollment; and the average time to enroll enough participants for 2 groups. Treatment-specific retention and attrition rates for hippotherapy, including the reasons for dropouts, and treatment-specific fidelity rates, including a measure of dose of hippotherapy and upper extremity activities, will be described.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical therapy incorporating hippotherapy and the equine environment | Experimental | Behavioral: HippotherapyFour 1 hour Hippotherapy treatments per week for four weeks. |
| Waitlist Control | No intervention | –A waitlist control that will receive hippotherapy intervention (four 1 hour Hippotherapy treatments per week for four weeks.) Four weeks later than the 'Physical therapy incorporating hippotherapy and the equine environment' Group. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children age 6 to 17
- Diagnosis of Cerebral Palsy with Gross Motor Functional Classification System (GMFCS) Level I, II, or III with upper extremity affected Cerebral Palsy and/or Autism Spectrum Disorder
- Able to follow simple verbal instructions in English
- Able to tolerate sitting on a horse continuously for 30 minutes
Key exclusion criteria (4 listed)
- Fear of or aversion to horses
- Weight over 200 lb
- Lacking independent head control (GMFCS level IV and V)
- Both parents unable to speak and read English
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 |
|---|---|---|
| HippotherapyTwo 1-hour sessions of hippotherapy for eight weeks. | Behavioural | Physical therapy incorporating hippotherapy and the equine environment |
Primary outcome
Reach-and grasp protocol
Time frame: 1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period.
Reach-and-grasp protocol: Participants were recorded while performing a reach-to-drink task. For each trial, participants were instructed: "Reach for the bottle, pick it up, pretend to take a drink, return the bottle to the marked position on the table, and return your hand to the start position. Do this twice." Movement of the upper extremities was recorded from reflective markers on the hands, wrists, elbows, shoulders, and sternum by a 10-camera VICON Motion Capture system at 120 Hz and filtered at 4 Hz with a low-pass Butterworth filter.
PEM-CY
Time frame: 1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period
Participation and Environment Measure for Children and Youth; higher scores mean better; participation scores range 0-7, involvement scores range 1-5.
PRIME-O
Time frame: 1 time per week during the 4-week intervention period
Pediatric Rehabilitation Intervention Measure of Engagement - Observation; higher scores = more engaged; score range = 0-40 (0-4 per item)
PRIME-SP
Time frame: 1 time per week during the 4-week intervention period
Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider; not scaled
Enjoy
Time frame: 1 time per week during the 4-week intervention period
Self-report measure of enjoyment of an activity. The scale has 25 statements that respondents rate on a 7-point Likert scale the degree to which they agree or disagree with each statement. There are 5 sections of the measure that cover different components of enjoyment: pleasure, relatedness, competence, challenge/improvement, and engagement. higher scores = more enjoyment; scores range 1-7 per item.
VABS
Time frame: 1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period
Vineland Adaptive Behavior Scale 2nd Edition; high scores mean better; Adaptive Behavior Composite standard score range: 20-160.
CAPE/PAC
Time frame: 1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period
Child Assessment of Participation and Enjoyment / Preference for Activities in Children; higher scores mean better; score range CAPE = 55-275 (1-5 per item), PAC = 55-165 (1-3 per item)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Cerebral Palsy, run by Ohio State 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 4 inclusion and 4 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 31 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reach-and grasp protocol (time frame: 1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2024; AzTrials last refreshed its copy on 29 Oct 2026.