Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530680
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Upper Extremity Function Before and After Hippotherapy in Children With Autism Spectrum Disorder andor Cerebral Palsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Upper Extremity Function Activity Participation and Engagement Before and After Hippotherapy in Children With Autism Spectrum Disorder andor Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Intervention Participants will receive 4 weeks of hippotherapy 4 1-hour sessions per week for a total of 16 hours of intervention If the participants miss a session make-up sessions will be offered scheduled and tracked51
Hippotherapy The hippotherapy intervention will be delivered at Dreams on Horseback in central Ohio using Professional Association of Therapeutic Horsemanship PATH Intl standards Participants will be mounted on a horse for at least 30 minutes of the 1-hour session Activities for the remaining time include grooming and tacking of the horses mounting and dismounting A herd of 9 horses will be used for hippotherapy sessions There will be 2 volunteers assisting with every session one to lead the horse and one to walk alongside the participant opposite the treating therapist Dreams on Horseback has a part-time Volunteer Coordinator who currently schedules 154 volunteers for 22 hours of equine-assisted activities per week Monday - Saturday Activities will include various positions on the horse such as sitting and quadruped weight bearing through the upper extremities and knees as well as reaching and throwing controlling the horse with the reins and riding the horse at a walk and a trot as is suggested by PATH Intl Standards Using the observation protocol in the preliminary data section one researcher will video record one hippotherapy session each week and document the therapeutic activities performed A second researcher will score 20 of the sessions to assure reliability of 90 Categories expected based on preliminary data are transitions ground poles directional changes reaches outside of base of support reaches weight bearing through upper extremities using reins holding upper extremities off of the horse position on the horse with or without stirrups standing sitting posting and kickingsqueezing the horse with legs This analysis will allow the investigators to quantify the dose of hippotherapy focus on the impact of therapeutic targets to the upper extremities and allow the investigators to evaluate adherence to the hippotherapy protocol
Treating Therapists All treating therapists will be licensed PTs and will have completed at least the AHA Level I Hippotherapy Treatment Principles
Since the goal of pilot studies is not to test efficacy no inferential statistics are proposed The investigators will analyze questions pertaining to 1 the recruitment success of children with CPASD ages 5-15 2 whether participants adhere to what they are asked to do during the pilot RCT and 3 if the treatment can be successfully delivered per protocol The investigators will describe the number of potential participants screened per month the number enrolled per month the average time delay from screening to enrollment and the average time to enroll enough participants for 2 groups Treatment-specific retention and attrition rates for hippotherapy including the reasons for dropouts and treatment-specific fidelity rates including a measure of dose of hippotherapy and upper extremity activities will be described
Hippotherapy The hippotherapy intervention will be delivered at Dreams on Horseback in central Ohio using Professional Association of Therapeutic Horsemanship PATH Intl standards Participants will be mounted on a horse for at least 30 minutes of the 1-hour session Activities for the remaining time include grooming and tacking of the horses mounting and dismounting A herd of 9 horses will be used for hippotherapy sessions There will be 2 volunteers assisting with every session one to lead the horse and one to walk alongside the participant opposite the treating therapist Dreams on Horseback has a part-time Volunteer Coordinator who currently schedules 154 volunteers for 22 hours of equine-assisted activities per week Monday - Saturday Activities will include various positions on the horse such as sitting and quadruped weight bearing through the upper extremities and knees as well as reaching and throwing controlling the horse with the reins and riding the horse at a walk and a trot as is suggested by PATH Intl Standards Using the observation protocol in the preliminary data section one researcher will video record one hippotherapy session each week and document the therapeutic activities performed A second researcher will score 20 of the sessions to assure reliability of 90 Categories expected based on preliminary data are transitions ground poles directional changes reaches outside of base of support reaches weight bearing through upper extremities using reins holding upper extremities off of the horse position on the horse with or without stirrups standing sitting posting and kickingsqueezing the horse with legs This analysis will allow the investigators to quantify the dose of hippotherapy focus on the impact of therapeutic targets to the upper extremities and allow the investigators to evaluate adherence to the hippotherapy protocol
Treating Therapists All treating therapists will be licensed PTs and will have completed at least the AHA Level I Hippotherapy Treatment Principles
Since the goal of pilot studies is not to test efficacy no inferential statistics are proposed The investigators will analyze questions pertaining to 1 the recruitment success of children with CPASD ages 5-15 2 whether participants adhere to what they are asked to do during the pilot RCT and 3 if the treatment can be successfully delivered per protocol The investigators will describe the number of potential participants screened per month the number enrolled per month the average time delay from screening to enrollment and the average time to enroll enough participants for 2 groups Treatment-specific retention and attrition rates for hippotherapy including the reasons for dropouts and treatment-specific fidelity rates including a measure of dose of hippotherapy and upper extremity activities will be described
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None