PT for Montana Children With NMD Using Hippotherapy and the Equine Environment

NCT06887647 | Recruiting DMC

• 2 other identifiers: IRB-FY2024-330P20GM103474
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. The main questions it aims to answer are:

1. 1.Is the study protocol feasible and acceptable for participants, that investigators could apply them to a larger trial?
2. 2.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?
3. 3.What are the physiological, behavioral, and emotional responses of children receiving physical therapy incorporating horses, versus those receiving standard physical therapy?

Conditions

Neuromotor Impairments

Keywords

physical therapy; hippotherapy; pediatric; motor function; participation; upper extremity function; equine environment; neurmotor disorder

Outcome Measures

Primary Outcomes (5)

• 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).

  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.

  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.

  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.

  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.

  12-month study period

Secondary Outcomes (6)

• Pediatric Rehabilitation Intervention Measure of Engagement - Observation (PRIME-O)

  week 2, 4, 6, 8 during treatment period

• High-Frequency Heart Rate Variability (HF-HRV)

  week 2, 4, 6, 8 during treatment period

• Salivary Oxytocin

  week 2, 4, 6, 8 during treatment period

• How Happy Scale

  week 2, 4, 6, 8 during treatment period

• Behavioral Coding

  week 2, 4, 6, 8 during treatment period

Other Outcomes (2)

• Fidelity of Treatment Delivery

  4 randomly-selected treatment sessions over an 8-week period per participant

• Fidelity of Treatment Receipt

  4 randomly-selected treatment sessions over an 8-week period per participant

Study Arms (2)

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.

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.

Other: Physical Therapy Using Hippotherapy and the Equine Environment

Interventions

Physical Therapy Using Hippotherapy and the Equine Environment OTHER

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: 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)

Physical Therapy Using Hippotherapy and the Equine Environment

Standard Play-Based Physical Therapy OTHER

The 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)

Play-Based Physical Therapy

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• University of Montana: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Montana

Missoula, Montana, 59812, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39515374 BACKGROUND

Related Links

• PI Website

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 20, 2025
• Study Start: August 20, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)