Physical Therapy for Montana Children With NMD Using Hippotherapy and the Equine Environment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- ABILHAND-KIDS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Play-Based Physical Therapy
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.
干预措施: Standard Play-Based Physical Therapy (Other)
Physical Therapy Using Hippotherapy and the Equine Environment
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.
干预措施: Physical Therapy Using Hippotherapy and the Equine Environment (Other)
结局指标
主要结局
ABILHAND-KIDS
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
ABILHAND-KIDS
时间窗: 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)
时间窗: 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)
时间窗: 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.
Feasibility of study protocol
时间窗: 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.
Bruininks-Oseretski Test of Motor Proficiency - Third Edition
时间窗: 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.
次要结局
- 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)
- Salivary Cortisol(week 2, 4, 6, 8 during treatment period)