Upper Extremity Function Before and After Hippotherapy in Children With Autism Spectrum Disorder and/or Cerebral Palsy

NCT06530680 | Completed

• 1 other identifier: 2020B0434
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this feasibility trial is to learn if hippotherapy and physical therapy in the equine environment can be used to improve upper extremity function in children with cerebral palsy or autism spectrum disorder who present with motor delay or impairment in the upper extremities. The main questions it aims to answer are: Can the upper extremity-focused treatment using hippotherapy and the equine environment be delivered to fidelity? Is the treatment acceptable to participants and therapists? Is the randomized-controlled trial protocol feasible to scale to a larger study, including recruitment and retention rates and suitability of selected outcome measures? If there is a comparison group: Researchers will compare participants receiving treatment to a waitlist control to see if participants are retained in the control group and if differences are detected between the control and treatment groups on selected outcome measures.

Conditions

Autism Spectrum Disorder; Cerebral Palsy

Outcome Measures

Primary Outcomes (7)

• Reach-and grasp protocol

  Reach-and-grasp protocol: Participants were recorded while performing a reach-to-drink task. For each trial, participants were instructed: "Reach for the bottle, pick it up, pretend to take a drink, return the bottle to the marked position on the table, and return your hand to the start position. Do this twice." Movement of the upper extremities was recorded from reflective markers on the hands, wrists, elbows, shoulders, and sternum by a 10-camera VICON Motion Capture system at 120 Hz and filtered at 4 Hz with a low-pass Butterworth filter.

  1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period.

• PEM-CY

  Participation and Environment Measure for Children and Youth; higher scores mean better; participation scores range 0-7, involvement scores range 1-5.

  1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period

• PRIME-O

  Pediatric Rehabilitation Intervention Measure of Engagement - Observation; higher scores = more engaged; score range = 0-40 (0-4 per item)

  1 time per week during the 4-week intervention period

• PRIME-SP

  Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider; not scaled

  1 time per week during the 4-week intervention period

• Enjoy

  Self-report measure of enjoyment of an activity. The scale has 25 statements that respondents rate on a 7-point Likert scale the degree to which they agree or disagree with each statement. There are 5 sections of the measure that cover different components of enjoyment: pleasure, relatedness, competence, challenge/improvement, and engagement. higher scores = more enjoyment; scores range 1-7 per item.

  1 time per week during the 4-week intervention period

• VABS

  Vineland Adaptive Behavior Scale 2nd Edition; high scores mean better; Adaptive Behavior Composite standard score range: 20-160.

  1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period

• CAPE/PAC

  Child Assessment of Participation and Enjoyment / Preference for Activities in Children; higher scores mean better; score range CAPE = 55-275 (1-5 per item), PAC = 55-165 (1-3 per item)

  1 week pre- and post- 4-week waitlist control period and within 1 week pre- and post- 4-week treatment period

Study Arms (2)

Physical therapy incorporating hippotherapy and the equine environment

EXPERIMENTAL

Four 1 hour Hippotherapy treatments per week for four weeks.

Behavioral: Hippotherapy

Waitlist Control

NO INTERVENTION

A waitlist control that will receive hippotherapy intervention (four 1 hour Hippotherapy treatments per week for four weeks.) Four weeks later than the 'Physical therapy incorporating hippotherapy and the equine environment' Group.

Interventions

Hippotherapy BEHAVIORAL

Two 1-hour sessions of hippotherapy for eight weeks.

Physical therapy incorporating hippotherapy and the equine environment

Eligibility Criteria

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

You may qualify if:

• Children age 6 to 17
• Diagnosis of Cerebral Palsy with Gross Motor Functional Classification System (GMFCS) Level I, II, or III with upper extremity affected Cerebral Palsy and/or Autism Spectrum Disorder
• Able to follow simple verbal instructions in English
• Able to tolerate sitting on a horse continuously for 30 minutes

You may not qualify if:

• Fear of or aversion to horses
• Weight over 200 lb
• Lacking independent head control (GMFCS level IV and V)
• Both parents unable to speak and read English

Sponsors & Collaborators

• Ohio State University: lead
• Nationwide Children's Hospital: collaborator
• University of Montana: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Cerebral Palsy

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Animal Assisted Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 31, 2024
• Study Start: June 14, 2021
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

US (1)