Neuromotor ImpairmentsNCT06887647
Physical Therapy for Montana Children With NMD Using Hippotherapy and the Equine Environment
A study testing Physical Therapy Using Hippotherapy and the Equine Environment and Standard Play-Based Physical Therapy in people with Neuromotor Impairments, run by University of Montana at 1 site in United States.
Trial summary
The goal of this pilot clinical trial is to determine if physical therapy incorporating horses can improve the motor skills of the arms in children 6-17 years old with neuromotor disorders (such as cerebral palsy, spinal muscular atrophy, or spina bifida) compared to standard play-based physical therapy. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Neuromotor Impairments
- What is being tested?
- Physical Therapy Using Hippotherapy and the Equine Environment and Standard Play-Based Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 1) 6-17 years old; 2) Diagnosed NMD with upper extremity impairment; 3) Able to follow simple verbal instructions in English; 4) Able to tolerate sitting on a horse continuously for 30 minutes; and 5) Meet Professional Association of Therapeutic Horsemanship International (PATH Intl.) standards for participating in mounted activities.
Who cannot join
- 1) Fear of or aversion to horses; 2) Weight over 200lbs (to protect safety and wellbeing of therapists and equines) 3) Participation in a horseback-riding program in the past 3 months; 4) Lacking independent head control; and 5) Caregivers unable to speak and read English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Montana
Missoula, Montana, 59812
Julia E Mazzarella, DPT, PhD, 406-243-4684, julia.mazzarella@umt.edu
Julia E Mazzarella, DPT, PhD
About this study
The goal of this pilot clinical trial is to determine if physical therapy incorporating horses can improve the motor skills of the arms in children 6-17 years old with neuromotor disorders (such as cerebral palsy, spinal muscular atrophy, or spina bifida) compared to standard play-based physical therapy. The main questions it aims to answer are:
- Is the study protocol feasible and acceptable for participants, that investigators could apply them to a larger trial?
- Do participants make improvements toward their goals for motor function, arm use, and participation in life situations following treatment, and is it different between the experimental and comparative intervention groups?
- What are the physiological, behavioral, and emotional responses of children receiving physical therapy incorporating horses, versus those receiving standard physical therapy?
Read more
Researchers will compare the experimental group who receive physical therapy incorporating horses to the comparative intervention group who receive standard play-based physical therapy to see if there is a difference in outcomes.
Participants will complete a pre- and post-intervention assessment of their motor function and participation in life situations. Participants will receive physical therapy twice a week for 8 weeks for the intervention. In both groups, physiological, behavioral, and emotional responses to the interventions will be measured in 4 total sessions, 1 each at weeks 2, 4, 6, and 8.
Read the detailed description
The long-term goal is to increase the variety of effective PT interventions for children with NMD, to achieve optimum outcomes for all. The investigators have already completed a pilot feasibility randomized-controlled trial (RCT) with waitlist control of an intervention targeting upper extremity function and participation in children with neuromotor disorders. The intervention protocol was feasible, but certain aspects of the RCT protocol needed to be revised. Aim 1 of this proposal evaluates the feasibility of these revisions by: 1) establishing an appropriate control condition, 2) evaluating replacement outcome measures for those that were not feasible; and 3) determining effects of a different treatment dosage on retention and attendance. Aim 2 will explore preliminary effects of the intervention on motor function and participation and Aim 3 will explore behavioral and physiological responses.
Aim 1: Evaluate the feasibility of the RCT protocol comparing an 8-week PT intervention using hippotherapy and the equine environment with a play-based PT control group targeting motor function and participation for children with NMD. Inestigators will track recruitment, retention, attendance, outcome measure completion, and reasons for absences and withdrawal. Investigators will assess fidelity and acceptability of the treatments for both groups. This will inform design of a large-scale RCT with full statistical power. Investigators hypothesize that they will recruit and randomize 24 participants with >80% retention, treatment attendance, and outcome measure completion in both groups; and both groups will meet >80% intervention fidelity and demonstrate acceptability.
Aim 2: Identify preliminary effects of an 8-week PT intervention using hippotherapy and the equine environment on motor function and participation compared to play-based PT for children with NMD. Investigators will measure motor function (BOT-3, ABILHANDKIDS), individual goal attainment (GAS), and participation (PEM-CY) before and after the 8-week treatment period for all participants and compare the average change score between the treatment and control groups. Investigators hypothesize that group average scores will improve from pre- to post-treatment for both groups, with a greater change in the treatment group compared to the control group.
Aim 3: Compare physiological, behavioral, and emotional responses in children with NMD during PT sessions incorporating equine interaction versus play-based PT. Investigators will calculate changes in high-frequency heart rate variability (HF-HRV) - the gold standard method of measuring parasympathetic nervous system activity - before, during, and after a treatment session. Investigators will measure levels of salivary oxytocin and cortisol before and after a treatment session. Investigators will assess engagement during treatment using behavioral coding and an observational rating scale. Enjoyment will be measured via patient report on a visual-analog scale following treatment. These measures will be collected during 4 treatment sessions (every 2 weeks) throughout the intervention. Investigators hypothesize that the intervention group will demonstrate an immediate increase in HF-HRV and salivary oxytocin, and a decrease in salivary cortisol after a single 60-minute session and sustained over the course of the 8-week intervention; participants will demonstrate sustained high engagement and enjoyment over the course of the intervention, and ratings of engagement and enjoyment will be greater than in the control condition; and physiological changes and behavioral ratings will be significantly positively correlated with the outcomes measured in Aim 2.
Background and Rationale There is a growing number of children with NMD across the United States. In rural areas like Montana, access and adherence to PT is especially challenging. Offering PT services in an equine environment can increase access to rural populations and provide PT in setting that might be more motivating and engaging for children, however there is a need to further evaluate its efficacy for improving important outcomes, like motor function and participation. The investigators began to address this need with a previous feasibility RCT which is linked in References. In Aim 1 investigators will implement changes identified to improve feasibility of the RCT protocol: 1) add additional screening to confirm that participants can complete all measures; 2) assess the feasibility of a play-based PT control condition; 3) test the reduced frequency of 2x/ week with a larger sample, and 4) replace the outcome measures that had low completion rates. Results from Aim 1 will inform the design of a large-scale clinical efficacy trial. In Aim 2, investigators will evaluate preliminary efficacy of the PT intervention using hippotherapy and the equine environment. This will provide the justification for a large-scale efficacy trial, and data for a power analysis.
PT using hippotherapy and the equine environment involves interaction between the patient and the equine. Emerging research has shown positive physiological and behavioral impacts of human-animal interactions. This PI's pilot study, which is not yet published, is the first known study to evaluate patient behavioral and physiological responses to HEI during a PT session. In Aim 3, investigators will evaluate these responses longitudinally, compare them to a control intervention, and investigate their potential moderation of patient outcomes.
Study Design A pilot, randomized-controlled trial with 24 children with NMD who will be assigned to either the PT intervention using hippotherapy and the equine environment or a standard PT control condition.
Participants Investigators will recruit 24 children from rehabilitation clinics, schools, and recreational centers around Western Montana.
Screening A research assistant will screen interested participants by phone. Those who meet initial inclusion criteria will attend a screening visit to ensure they can safely mount and dismount the equine, can provide a saliva sample, can follow simple verbal instructions, and can ambulate independently.
Sample Size The study design was determined using guidance in the NIH document Pilot Studies: Common Uses and Misuses. Investigators concluded that 80%+ power is not necessary for the current proposal because intervention efficacy is not being tested, which would require a larger sample size and length of time than this funding mechanism accommodates. Rather, the sample size is "based on practical considerations including participant flow, budgetary constraints, and the number of participants needed to reasonably evaluate goals."36 A sample size of 24 will allow sufficient participant variability to assess the feasibility of changes made to the RCT protocol and provide insight into preliminary effects of the intervention (see Preliminary Data). The investigators have assembled a strong network of recruitment partners and treatment sites (see Letters of Support) to ensure that completion of study aims with a sample of 24 subjects is achievable within the 12-month timeline.
Setting Participant baseline and post-intervention assessments and the control group treatment sessions will take place at the Pediatric Rehabilitation and Active Lifestyle (PALS) Lab at the University of Montana. The PALS lab is a 1000 ft2 space with two private assessment spaces and a waiting area for caregivers and families. The equine intervention will occur at Trotting Horse Therapeutic Riding (THTR) in Missoula, Hobby Horse Place in Polson, and Two Bear Therapeutic Riding Center in Whitefish (see Letters of Support). The facilities have accessible indoor arenas and trained therapy equines and equine professionals.
Therapists Therapists for the equine treatment are licensed physical therapists who have the recommended training to incorporate hippotherapy and the equine environment into treatment (American Hippotherapy Association (AHA) Inc. Hippotherapy Treatment Principles Part I and II). Each therapist will work with an equine professional with PATH Intl. Therapeutic Riding Instructor Certification, to ensure that therapists adhere to industry standards for safety and handling of the equines. The standard PT control intervention will be delivered by Doctor of Physical Therapy (DPT) students under the direct supervision of a licensed physical therapist.
Outcomes Assessments Pre- and post-outcomes assessments will be completed by DPT students who are trained on standardized application of all measures and under direct supervision of a licensed PT (study PI). The assessors will be blinded to subject group assignments.
Measures
The following measures will be applied to all participants:
Feasibility Fidelity Delivery of intervention Receipt of intervention Reliability: Coders for fidelity will establish ≥85% reliability by coding the same video, comparing codes, discussing any discrepancies, and reaching a consensus on any item where codes were not in agreement. This process will be repeated until the codes are congruent for ≥85% of items for sufficient reliability. Once reliability is established, the remaining videos will be divided amongst coders.
Acceptability: The engagement (PRIME-O) and enjoyment (How Happy Scale) measures described below will be used as measures of participant acceptability of the intervention.
The following measures will be collected at baseline (week 0) and post-intervention (week 9) for both groups:
GMFM-88 ABILHAND-KIDS GAS PEM-CY
The following measures will be collected at weeks 2, 4, 6, and 8 for both groups:
PRIME-O HF-HRV Salivary Oxytocin Salivary Cortisol Adaptation of How Happy Scale Behavioral Coding
Analysis Aim 1: Descriptive statistics wil be used to calculate rates of enrollment, attendance, attrition, fidelity, and outcome measure completion. Reasons for study withdrawal, missed therapy sessions, or incomplete outcome assessments will be documented. Rates will be compared between the treatment and control groups using independent samples t-tests for attendance, attrition, and measure completion and GLMMRM for fidelity.
Aim 2: Changes in outcome scores from pre- to post-intervention will be compared between groups using generalized linear mixed models for repeated measures (GLMMRM). Where available, the percent of participants who meet a minimal clinically important difference (MCID) from pre- to post-intervention will be reported.
Aim 3: HF-HRV will be calculated for the pre-, during-, and post-session intervals and compare these means. Pre-post session changes in salivary oxytocin and cortisol will be compared. HF-HRV pre-to during-session mean change and oxytocin and cortisol pre- to post-session mean changes between groups will be compared. For the behavioral data, the percentage of scans where behaviors indicate a positive or negative mood will be calculated and the average frequency of each determined and compare between groups. Longitudinal changes will be compared for all variables throughout the intervention. GLMMRM will be used for all comparisons.
- Conditions
- Neuromotor Impairments
- Being tested
- Physical Therapy Using Hippotherapy and the Equine Environment, Standard Play-Based Physical Therapy
- Keywords
- physical therapy, hippotherapy, pediatric, motor function, participation, upper extremity function, equine environment, neurmotor disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy Using Hippotherapy and the Equine EnvironmentOther
Subjects will be mounted on a horse for 15-30 minutes. Therapeutic activities will include movements like reaching, throwing, and bilateral coordination tasks in addition to assuming various positions on the horse during equine movement, per the tolerance of individual participants. Remaining treatment time will involve participation-based functional motor activities in the equine environment, such as feeding and grooming horses.
Treatment will include the following active ingredients:
- Encourage use of both upper extremities during therapeutic activities.
- Design therapeutic activities with equines to guide practice of functional motor skills.
- Design therapeutic activities with the equines to practice participation (ie. activities involved in life situations).
- Utilize the presence of the equines to optimize patient mood and engagement in the therapeutic activities. (Design activities around patient strengths and preferences; use the equines as positive reinforcement)
Standard Play-Based Physical TherapyOther
The treatment will focus on encouragement of functional play activities, such as reaching, throwing, and catching games. Treatment will incorporate the following active ingredients:
- Encourage use of both upper extremities during therapeutic activities.
- Design therapeutic activities using play and games to guide practice of functional motor skills.
- Design therapeutic activities with play and games to practice participation (ie. activities involved in life situations).
- Utilize play and games to optimize patient mood and engagement in the therapeutic activities. (Design activities around patient strengths and preferences; use play and games as positive reinforcement)
| Study group | Role | What they receive |
|---|---|---|
| Play-Based Physical Therapy | Active comparator | Participants in the control group will receive 8 weeks of standard play-based PT, 2 x 1-hour sessions per week, for a total of 16 hours. The sessions will be implemented by a licensed PT. Receives: Other: Standard Play-Based Physical Therapy |
| Physical Therapy Using Hippotherapy and the Equine Environment | Experimental | Participants in the intervention group will receive 8 weeks of PT using hippotherapy and the equine environment, 2 x 1-hour sessions per week (16 hours total). Treatment will be provided by a licensed PT with the recommended training to incorporate hippotherapy and the equine environment into treatment (American Hippotherapy Association (AHA) Inc. Hippotherapy Treatment Principles Part I and II). Each therapist will work with an equine professional with PATH Intl. Therapeutic Riding Instructor Certification, to ensure that therapists adhere to industry standards for safety and handling of the equines. Receives: Other: Physical Therapy Using Hippotherapy and the Equine Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABILHAND-KIDS
The ABILHAND-KIDS is a parent-report measure of a child's bimanual abilities, meaning the use of both hands, in daily activities. It asks the parent to rate their child's ability to perform 21 different bimanual daily living activities on a 3-point scale (0=impossible, 1=difficult, 2=easy).
Measured: week 0 and week 9 (pre- and post-treatment)
Goal Attainment Scale (GAS)
The GAS is on a 5-point scale: -2, current level of performance at the time the goal is created; -1, less than expected level of performance after the 8-week intervention; 0, expected level of performance after intervention; +1, more than expected; and +2, much more than expected. Goals are determined through initial assessment and semi-structured interview with the caregiver. Goals are peer-reviewed to ensure each individual scale meets quality criteria. At the post-intervention assessment, the evaluating therapist will use direct observation and caregiver report to determine goal attainment.
Measured: week 0 and week 9 (pre- and post-treatment)
Participation and Environment Measure for Children and Youth (PEM-CY)
A parent-report measure of child participation in activities in the home, school, and community environments, and supports or hindrances to their participation. It includes several items rated on an ordinal scale for the child's level of participation and involvement in a variety of activities. There are also short-answer questions for caregivers to elaborate on supports and barriers to their child's participation in the 3 environments, and strategies the caregivers employ to encourage/facilitate participation and involvement.
Measured: week 0 and week 9 (pre- and post-treatment)
Bruininks-Oseretski Test of Motor Proficiency - Third Edition
The Bruininks-Oseretsky Test of Motor Proficiency - 3rd Edition is a comprehensive norm-referenced clinical measure for children and youth ages 4-21 years that covers 4 motor areas: (1) fine manual control, (2) manual coordination, (3) body coordination, and (4) strength and agility. The BOT has shown excellent test-retest reliability and good responsiveness in children with typical development and intellectual disability. Scaled scores can range from 0-20 and Standard scores can range from 0-200. Higher scores indicate better performance.
Measured: week 0 and week 9 (pre- and post-treatment)
Feasibility of study protocol
We will track recruitment, screening, enrollment, retention, attendance, and outcome measure completion. We will record reasons for withdrawal, missed treatments, and incomplete outcome measures.
Measured: 12-month study period
Secondary outcomes (6)
Pediatric Rehabilitation Intervention Measure of Engagement - Observation (PRIME-O)
A 10-item observational measure of patient and service-provider engagement that accounts for affective, cognitive, and behavioral aspects of engagement. Each item is rated on a scale from 0-4.
Measured: week 2, 4, 6, 8 during treatment period
High-Frequency Heart Rate Variability (HF-HRV)
This will be measured in the intervention group only. HF-HRV will be measured using Polar H10 heart rate sensors secured to the participant around their chest. These sensors are proven to have good reliability for measuring HF-HRV. Heart rate will be tracked for the entire therapy session in the equine environment, as well as for 5 minutes before and after the session, during which time the participant will maintain a similar level of activity, such as standing or walking, but away from the equines. For each time-interval a HF-HRV score will be assigned.
Measured: week 2, 4, 6, 8 during treatment period
Salivary Oxytocin
Saliva will be collected from participants within 5 minutes before and after the session using the passive drool method. This is a non-invasive procedure in which the participant drools into a collection tube. Saliva samples will be stored in a medical grade freezer at the PAL lab until shipped to Salimetrics for analysis of oxytocin concentrations.
Measured: week 2, 4, 6, 8 during treatment period
How Happy Scale
The How Happy Scale (HHS) uses a 4-point visual analog scale to evaluate a child's enjoyment of physical activity. It consists of 4 questions targeting the 4 contextual constructs of attraction, environment, social factors, and preference.
Measured: week 2, 4, 6, 8 during treatment period
Behavioral Coding
Scan sample coding will be used to describe participant behavior during rehabilitation in the equine environment. This involves watching the treatment session and recording the behaviors of the participant at regular intervals. For this study, we will set an interval of every 1 minute, for 60 samples per session. We will record behaviors indicative of mood and engagement, such as facial expressions, positive and negative vocalizations, and engagement with therapy activities and games. We will calculate frequency of the various behaviors for each session.
Measured: week 2, 4, 6, 8 during treatment period
Salivary Cortisol
Saliva will be collected from participants within 5 minutes before and after the session using the passive drool method. This is a non-invasive procedure in which the participant drools into a collection tube. Saliva samples will be stored in a medical grade freezer at the PAL lab until shipped to Salimetrics for analysis of oxytocin concentrations.
Measured: week 2, 4, 6, 8 during treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start20 Aug 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromotor ImpairmentsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887647
- Sponsor's protocol ID
- IRB-FY2024-330
- Other IDs
- P20GM103474
- Status last verified
- May 2026
- First submitted
- 10 Mar 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to share the IPD for further analysis by other researchers. We don't feel it is necessary for replicating results, as this is still a preliminary study.
Publications
Mazzarella J, Heathcock JC. A Randomized Feasibility Study of Rehabilitation Targeting Upper Extremity Function and Participation Using Hippotherapy and the Equine Environment for Children with Cerebral Palsy and Autism Spectrum Disorder. J Integr Complement Med. 2025 Feb;31(2):196-208. doi: 10.1089/jicm.2024.0292. Epub 2024 Nov 8.
PubMed 39515374
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy for Montana Children With NMD Using Hippotherapy and the Equine Environment
- ClinicalTrials.gov ID
- NCT06887647
- Acronym / sponsor ID
- IRB-FY2024-330
- Conditions
- Neuromotor Impairments
- Keywords
- physical therapy, hippotherapy, pediatric, motor function, participation, upper extremity function, equine environment, neurmotor disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 20 Mar 2025 (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 pilot clinical trial is to determine if physical therapy incorporating horses can improve the motor skills of the arms in children 6-17 years old with neuromotor disorders (such as cerebral palsy, spinal muscular atrophy, or spina bifida) compared to standard play-based physical therapy. The main questions it aims to answer are:
- Is the study protocol feasible and acceptable for participants, that investigators could apply them to a larger trial?
- Do participants make improvements toward their goals for motor function, arm use, and participation in life situations following treatment, and is it different between the experimental and comparative intervention groups?
- What are the physiological, behavioral, and emotional responses of children receiving physical therapy incorporating horses, versus those receiving standard physical therapy?
Researchers will compare the experimental group who receive physical therapy incorporating horses to the comparative intervention group who receive standard play-based physical therapy to see if there is a difference in outcomes.
Participants will complete a pre- and post-intervention assessment of their motor function and participation in life situations. Participants will receive physical therapy twice a week for 8 weeks for the intervention. In both groups, physiological, behavioral, and emotional responses to the interventions will be measured in 4 total sessions, 1 each at weeks 2, 4, 6, and 8.
Detailed description
The long-term goal is to increase the variety of effective PT interventions for children with NMD, to achieve optimum outcomes for all. The investigators have already completed a pilot feasibility randomized-controlled trial (RCT) with waitlist control of an intervention targeting upper extremity function and participation in children with neuromotor disorders. The intervention protocol was feasible, but certain aspects of the RCT protocol needed to be revised. Aim 1 of this proposal evaluates the feasibility of these revisions by: 1) establishing an appropriate control condition, 2) evaluating replacement outcome measures for those that were not feasible; and 3) determining effects of a different treatment dosage on retention and attendance. Aim 2 will explore preliminary effects of the intervention on motor function and participation and Aim 3 will explore behavioral and physiological responses.
Aim 1: Evaluate the feasibility of the RCT protocol comparing an 8-week PT intervention using hippotherapy and the equine environment with a play-based PT control group targeting motor function and participation for children with NMD. Inestigators will track recruitment, retention, attendance, outcome measure completion, and reasons for absences and withdrawal. Investigators will assess fidelity and acceptability of the treatments for both groups. This will inform design of a large-scale RCT with full statistical power. Investigators hypothesize that they will recruit and randomize 24 participants with >80% retention, treatment attendance, and outcome measure completion in both groups; and both groups will meet >80% intervention fidelity and demonstrate acceptability.
Aim 2: Identify preliminary effects of an 8-week PT intervention using hippotherapy and the equine environment on motor function and participation compared to play-based PT for children with NMD. Investigators will measure motor function (BOT-3, ABILHANDKIDS), individual goal attainment (GAS), and participation (PEM-CY) before and after the 8-week treatment period for all participants and compare the average change score between the treatment and control groups. Investigators hypothesize that group average scores will improve from pre- to post-treatment for both groups, with a greater change in the treatment group compared to the control group.
Aim 3: Compare physiological, behavioral, and emotional responses in children with NMD during PT sessions incorporating equine interaction versus play-based PT. Investigators will calculate changes in high-frequency heart rate variability (HF-HRV) - the gold standard method of measuring parasympathetic nervous system activity - before, during, and after a treatment session. Investigators will measure levels of salivary oxytocin and cortisol before and after a treatment session. Investigators will assess engagement during treatment using behavioral coding and an observational rating scale. Enjoyment will be measured via patient report on a visual-analog scale following treatment. These measures will be collected during 4 treatment sessions (every 2 weeks) throughout the intervention. Investigators hypothesize that the intervention group will demonstrate an immediate increase in HF-HRV and salivary oxytocin, and a decrease in salivary cortisol after a single 60-minute session and sustained over the course of the 8-week intervention; participants will demonstrate sustained high engagement and enjoyment over the course of the intervention, and ratings of engagement and enjoyment will be greater than in the control condition; and physiological changes and behavioral ratings will be significantly positively correlated with the outcomes measured in Aim 2.
Background and Rationale There is a growing number of children with NMD across the United States. In rural areas like Montana, access and adherence to PT is especially challenging. Offering PT services in an equine environment can increase access to rural populations and provide PT in setting that might be more motivating and engaging for children, however there is a need to further evaluate its efficacy for improving important outcomes, like motor function and participation. The investigators began to address this need with a previous feasibility RCT which is linked in References. In Aim 1 investigators will implement changes identified to improve feasibility of the RCT protocol: 1) add additional screening to confirm that participants can complete all measures; 2) assess the feasibility of a play-based PT control condition; 3) test the reduced frequency of 2x/ week with a larger sample, and 4) replace the outcome measures that had low completion rates. Results from Aim 1 will inform the design of a large-scale clinical efficacy trial. In Aim 2, investigators will evaluate preliminary efficacy of the PT intervention using hippotherapy and the equine environment. This will provide the justification for a large-scale efficacy trial, and data for a power analysis.
PT using hippotherapy and the equine environment involves interaction between the patient and the equine. Emerging research has shown positive physiological and behavioral impacts of human-animal interactions. This PI's pilot study, which is not yet published, is the first known study to evaluate patient behavioral and physiological responses to HEI during a PT session. In Aim 3, investigators will evaluate these responses longitudinally, compare them to a control intervention, and investigate their potential moderation of patient outcomes.
Study Design A pilot, randomized-controlled trial with 24 children with NMD who will be assigned to either the PT intervention using hippotherapy and the equine environment or a standard PT control condition.
Participants Investigators will recruit 24 children from rehabilitation clinics, schools, and recreational centers around Western Montana.
Screening A research assistant will screen interested participants by phone. Those who meet initial inclusion criteria will attend a screening visit to ensure they can safely mount and dismount the equine, can provide a saliva sample, can follow simple verbal instructions, and can ambulate independently.
Sample Size The study design was determined using guidance in the NIH document Pilot Studies: Common Uses and Misuses. Investigators concluded that 80%+ power is not necessary for the current proposal because intervention efficacy is not being tested, which would require a larger sample size and length of time than this funding mechanism accommodates. Rather, the sample size is "based on practical considerations including participant flow, budgetary constraints, and the number of participants needed to reasonably evaluate goals."36 A sample size of 24 will allow sufficient participant variability to assess the feasibility of changes made to the RCT protocol and provide insight into preliminary effects of the intervention (see Preliminary Data). The investigators have assembled a strong network of recruitment partners and treatment sites (see Letters of Support) to ensure that completion of study aims with a sample of 24 subjects is achievable within the 12-month timeline.
Setting Participant baseline and post-intervention assessments and the control group treatment sessions will take place at the Pediatric Rehabilitation and Active Lifestyle (PALS) Lab at the University of Montana. The PALS lab is a 1000 ft2 space with two private assessment spaces and a waiting area for caregivers and families. The equine intervention will occur at Trotting Horse Therapeutic Riding (THTR) in Missoula, Hobby Horse Place in Polson, and Two Bear Therapeutic Riding Center in Whitefish (see Letters of Support). The facilities have accessible indoor arenas and trained therapy equines and equine professionals.
Therapists Therapists for the equine treatment are licensed physical therapists who have the recommended training to incorporate hippotherapy and the equine environment into treatment (American Hippotherapy Association (AHA) Inc. Hippotherapy Treatment Principles Part I and II). Each therapist will work with an equine professional with PATH Intl. Therapeutic Riding Instructor Certification, to ensure that therapists adhere to industry standards for safety and handling of the equines. The standard PT control intervention will be delivered by Doctor of Physical Therapy (DPT) students under the direct supervision of a licensed physical therapist.
Outcomes Assessments Pre- and post-outcomes assessments will be completed by DPT students who are trained on standardized application of all measures and under direct supervision of a licensed PT (study PI). The assessors will be blinded to subject group assignments.
Measures
The following measures will be applied to all participants:
Feasibility Fidelity Delivery of intervention Receipt of intervention Reliability: Coders for fidelity will establish ≥85% reliability by coding the same video, comparing codes, discussing any discrepancies, and reaching a consensus on any item where codes were not in agreement. This process will be repeated until the codes are congruent for ≥85% of items for sufficient reliability. Once reliability is established, the remaining videos will be divided amongst coders.
Acceptability: The engagement (PRIME-O) and enjoyment (How Happy Scale) measures described below will be used as measures of participant acceptability of the intervention.
The following measures will be collected at baseline (week 0) and post-intervention (week 9) for both groups:
GMFM-88 ABILHAND-KIDS GAS PEM-CY
The following measures will be collected at weeks 2, 4, 6, and 8 for both groups:
PRIME-O HF-HRV Salivary Oxytocin Salivary Cortisol Adaptation of How Happy Scale Behavioral Coding
Analysis Aim 1: Descriptive statistics wil be used to calculate rates of enrollment, attendance, attrition, fidelity, and outcome measure completion. Reasons for study withdrawal, missed therapy sessions, or incomplete outcome assessments will be documented. Rates will be compared between the treatment and control groups using independent samples t-tests for attendance, attrition, and measure completion and GLMMRM for fidelity.
Aim 2: Changes in outcome scores from pre- to post-intervention will be compared between groups using generalized linear mixed models for repeated measures (GLMMRM). Where available, the percent of participants who meet a minimal clinically important difference (MCID) from pre- to post-intervention will be reported.
Aim 3: HF-HRV will be calculated for the pre-, during-, and post-session intervals and compare these means. Pre-post session changes in salivary oxytocin and cortisol will be compared. HF-HRV pre-to during-session mean change and oxytocin and cortisol pre- to post-session mean changes between groups will be compared. For the behavioral data, the percentage of scans where behaviors indicate a positive or negative mood will be calculated and the average frequency of each determined and compare between groups. Longitudinal changes will be compared for all variables throughout the intervention. GLMMRM will be used for all comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Play-Based Physical Therapy | Active comparator | Other: Standard Play-Based Physical TherapyParticipants in the control group will receive 8 weeks of standard play-based PT, 2 x 1-hour sessions per week, for a total of 16 hours. The sessions will be implemented by a licensed PT. |
| Physical Therapy Using Hippotherapy and the Equine Environment | Experimental | Other: Physical Therapy Using Hippotherapy and the Equine EnvironmentParticipants in the intervention group will receive 8 weeks of PT using hippotherapy and the equine environment, 2 x 1-hour sessions per week (16 hours total). Treatment will be provided by a licensed PT with the recommended training to incorporate hippotherapy and the equine environment into treatment (American Hippotherapy Association (AHA) Inc. Hippotherapy Treatment Principles Part I and II). Each therapist will work with an equine professional with PATH Intl. Therapeutic Riding Instructor Certification, to ensure that therapists adhere to industry standards for safety and handling of the equines. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1) 6-17 years old; 2) Diagnosed NMD with upper extremity impairment; 3) Able to follow simple verbal instructions in English; 4) Able to tolerate sitting on a horse continuously for 30 minutes; and 5) Meet Professional Association of Therapeutic Horsemanship International (PATH Intl.) standards for participating in mounted activities.
Key exclusion criteria (1 listed)
- 1) Fear of or aversion to horses; 2) Weight over 200lbs (to protect safety and wellbeing of therapists and equines) 3) Participation in a horseback-riding program in the past 3 months; 4) Lacking independent head control; and 5) Caregivers 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 |
|---|---|---|
| Physical Therapy Using Hippotherapy and the Equine EnvironmentSubjects will be mounted on a horse for 15-30 minutes. Therapeutic activities will include movements like reaching, throwing, and bilateral coordination tasks in addition to assuming various positions on the horse during equine movement, per the tolerance of individual participants. Remaining treatment time will involve participation-based functional motor activities in the equine environment, such as feeding and grooming horses. Treatment will include the following active ingredients: 1. Encourage use of both upper extremities during therapeutic activities. 2. Design therapeutic activities with equines to guide practice of functional motor skills. 3. Design therapeutic activities with the equines to practice participation (ie. activities involved in life situations). 4. Utilize the presence of the equines to optimize patient mood and engagement in the therapeutic activities. (Design activities around patient strengths and preferences; use the equines as positive reinforcement) | Other | Physical Therapy Using Hippotherapy and the Equine Environment |
| Standard Play-Based Physical TherapyThe treatment will focus on encouragement of functional play activities, such as reaching, throwing, and catching games. Treatment will incorporate the following active ingredients: 1. Encourage use of both upper extremities during therapeutic activities. 2. Design therapeutic activities using play and games to guide practice of functional motor skills. 3. Design therapeutic activities with play and games to practice participation (ie. activities involved in life situations). 4. Utilize play and games to optimize patient mood and engagement in the therapeutic activities. (Design activities around patient strengths and preferences; use play and games as positive reinforcement) | Other | Play-Based Physical Therapy |
Primary outcome
ABILHAND-KIDS
Time frame: week 0 and week 9 (pre- and post-treatment)
The ABILHAND-KIDS is a parent-report measure of a child's bimanual abilities, meaning the use of both hands, in daily activities. It asks the parent to rate their child's ability to perform 21 different bimanual daily living activities on a 3-point scale (0=impossible, 1=difficult, 2=easy).
Goal Attainment Scale (GAS)
Time frame: week 0 and week 9 (pre- and post-treatment)
The GAS is on a 5-point scale: -2, current level of performance at the time the goal is created; -1, less than expected level of performance after the 8-week intervention; 0, expected level of performance after intervention; +1, more than expected; and +2, much more than expected. Goals are determined through initial assessment and semi-structured interview with the caregiver. Goals are peer-reviewed to ensure each individual scale meets quality criteria. At the post-intervention assessment, the evaluating therapist will use direct observation and caregiver report to determine goal attainment.
Participation and Environment Measure for Children and Youth (PEM-CY)
Time frame: week 0 and week 9 (pre- and post-treatment)
A parent-report measure of child participation in activities in the home, school, and community environments, and supports or hindrances to their participation. It includes several items rated on an ordinal scale for the child's level of participation and involvement in a variety of activities. There are also short-answer questions for caregivers to elaborate on supports and barriers to their child's participation in the 3 environments, and strategies the caregivers employ to encourage/facilitate participation and involvement.
Bruininks-Oseretski Test of Motor Proficiency - Third Edition
Time frame: week 0 and week 9 (pre- and post-treatment)
The Bruininks-Oseretsky Test of Motor Proficiency - 3rd Edition is a comprehensive norm-referenced clinical measure for children and youth ages 4-21 years that covers 4 motor areas: (1) fine manual control, (2) manual coordination, (3) body coordination, and (4) strength and agility. The BOT has shown excellent test-retest reliability and good responsiveness in children with typical development and intellectual disability. Scaled scores can range from 0-20 and Standard scores can range from 0-200. Higher scores indicate better performance.
Feasibility of study protocol
Time frame: 12-month study period
We will track recruitment, screening, enrollment, retention, attendance, and outcome measure completion. We will record reasons for withdrawal, missed treatments, and incomplete outcome measures.
6 secondary outcomes
Pediatric Rehabilitation Intervention Measure of Engagement - Observation (PRIME-O)
Time frame: week 2, 4, 6, 8 during treatment period
High-Frequency Heart Rate Variability (HF-HRV)
Time frame: week 2, 4, 6, 8 during treatment period
Salivary Oxytocin
Time frame: week 2, 4, 6, 8 during treatment period
How Happy Scale
Time frame: week 2, 4, 6, 8 during treatment period
Behavioral Coding
Time frame: week 2, 4, 6, 8 during treatment period
Salivary Cortisol
Time frame: week 2, 4, 6, 8 during treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 39515374Mazzarella J, Heathcock JC. A Randomized Feasibility Study of Rehabilitation Targeting Upper Extremity Function and Participation Using Hippotherapy and the Equine Environment for Children with Cerebral Palsy and Autism Spectrum Disorder. J Integr Complement Med. 2025 Feb;31(2):196-208. doi: 10.1089/jicm.2024.0292. Epub 2024 Nov 8.
- PI WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. At this time, there is no plan to share the IPD for further analysis by other researchers. We don't feel it is necessary for replicating results, as this is still a preliminary study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy Using Hippotherapy and the Equine Environment and Standard Play-Based Physical Therapy in people with Neuromotor Impairments, run by University of Montana 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABILHAND-KIDS (time frame: week 0 and week 9 (pre- and post-treatment)). The study lists 5 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 NCT06887647, 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 14 May 2026.