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.
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.
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.
Parallel
Physical Therapy Using Hippotherapy and the Equine Environment
Other interventionSubjects 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)
Standard Play-Based Physical Therapy
Other interventionThe 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)
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).
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.
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.
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.
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.
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.
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.
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.
Fidelity of Treatment Delivery
We will measure adherence to the treatment protocol by completing a checklist of the active ingredients of the intervention that are observed in the video-recorded treatment session. The outcome will be the percentage of checklist items marked as observed.
Fidelity of Treatment Receipt
The videos will be coded in Datavyu to identify participant behavior that demonstrates receipt of the intervention. Coding categories include the amount of time mounted on the horse, the amount of time completing specific participation-based activities, and completing discrete upper extremity activities such as: reaching within the base of support, reaching outside the base of support, throwing items, carrying items, holding items, grooming the horse, sweeping or mucking stalls, and clipping or latching items or doors. Each activity will be coded with information on the upper extremity(ies) being used, the type of activity occurring, and whether the activity practiced participation.
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University of Montana
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
