NCT06887647 · University of Montana
Physical Therapy for Montana Children With NMD Using Hippotherapy and the Equine Environment
What this study is about
The goal of this pilot clinical trial is to determine if physical therapy incorporating horses can improve the motor skills of the treatment group$1 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.
View original scientific description
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. Is the study protocol feasible and acceptable for participants, that investigators could apply them to a larger trial? 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. 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.
Interventions
OTHER
Physical Therapy Using Hippotherapy and the Equine Environment
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)
OTHER
Standard Play-Based Physical Therapy
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)
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Missoula, Montana
Collaborators
National Institute of General Medical Sciences (NIGMS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations