Motor Skill Proficiency After Equine-assisted Activities and Brain-building Tasks
Primary Purpose
Motor Delay, Motor Skills Disorders, Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Equine-assisted activities
GaitWay program
Sponsored by
About this trial
This is an interventional treatment trial for Motor Delay
Eligibility Criteria
Inclusion Criteria:
- age 5 to 18 years
- diagnosis of a neurodevelopmental disorder (as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5))
- had the ability to follow verbal directions,
- Clearance to participate from a medical professional
Exclusion Criteria:
- a perfect score on the motor proficiency test at the first testing session
- presence of seizures within the past 6 months controlled by medication
- a known allergy to horses
- any surgical procedures performed within the 6 months
- regular horseback riding experience of any kind during the past year
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
No Intervention
Experimental
Arm Label
Control
Equine-assisted activities period
Washout
GaitWay period
Arm Description
Control period; no equine-assisted activities or brain-building activities occurred
Period in which only equine-assisted activities were performed
Washout period; no equine-assisted activities or brain-building activities occurred
Period in which both equine-assisted activities and brain-building activities were performed
Outcomes
Primary Outcome Measures
Fine motor precision
Subtest #1 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Tasks include drawing through lines, folding paper. Each task within this subtest is scored on a scale from 0-7 (with 7 representing the best outcome).
Fine motor integration
Subtest #2 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Task includes copying a star and a square. The task within this subtest is scored on a scale from 0-5 (with 5 representing the best outcome).
Manual dexterity
Subtest #3 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Task includes transferring pennies. The task within this subtest is scored on a scale from 0-9 (with 9 representing the best outcome).
Bilateral coordination
Subtest #4 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Tasks include jumping in place with arms and legs on same side of the body synchronized, and tapping feet and fingers simultaneously, with hands and feet on the same side of the body synchronized. The jumping task within this subtest is scored on a scale from 0-3 (with 3 representing the best outcome). The tapping task within this subtest is scored on a scale from 0-4 (with 4 representing the best outcome).
Balance
Subtest #5 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Tasks include walking forward on a line, standing on one leg on a balance beam with eyes open. Each task within this subtest is scored on a scale from 0-4 (with 4 representing the best outcome).
Running speed and agility
Subtest #6 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Task includes one-legged stationary hop. The task within this subtest is scored on a scale from 0-10 (with 10 representing the best outcome).
Upper-limb coordination
Subtest #7 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Tasks include dropping and catching a ball with both hands, dribbling a ball with alternating hands. The dropping and catching task within this subtest is scored on a scale from 0-5 (with 5 representing the best outcome). The dribbling task within this subtest is scored on a scale from 0-7 (with 7 representing the best outcome).
Strength
Subtest #8 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Tasks include knee push-ups and sit-ups. Each task within this subtest is scored on a scale from 0-10 (with 10 representing the best outcome).
Overall Motor Skill Scores
Sum of all scores from the 8 subtests of the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Total scores can range from 0-88 (with 88 representing the best outcome)
Secondary Outcome Measures
Caregiver reports
Anecdotal reports from caregivers regarding progress of the participant
Full Information
NCT ID
NCT04158960
First Posted
November 5, 2019
Last Updated
November 6, 2019
Sponsor
Texas Woman's University
1. Study Identification
Unique Protocol Identification Number
NCT04158960
Brief Title
Motor Skill Proficiency After Equine-assisted Activities and Brain-building Tasks
Official Title
Changes in Motor Skill Proficiency After Equine-Assisted Activities and Brain-Building Tasks in Youth With Neurodevelopmental Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is no current research to support the efficacy of a combination of equine-assisted activities (EAA) and brain building activities to influence motor skill competencies in youth with neurodevelopmental disorders (ND). The primary objective of this study was to quantify changes in motor skill proficiency before and after 8 weeks of EAA and brain-building activities in youth with ND. A secondary objective was to quantify changes in motor skill proficiency before and after 1 year of EAA and brain-building activities in youth with ND.
Detailed Description
Twenty-five youth completed the same 32-week protocol that was separated into 4, 8-week blocks, in the following order: a) control, b) EAA-only, c) washout, and d) GaitWay block (EAA and brain building activities). Before and after each block, motor skills were assessed using the Short Form of the Bruininks-Oseretsky Test of Motor Proficiency-Version 2 (BOT-2). Seven youth continued with the GaitWay intervention for one additional year, and the BOT-2 Short Form was also administered following this intervention. A repeated-measures analysis-of-variance was performed to compare BOT-2 subtest and overall scores between interventions. A significance of .05 was used. Manual dexterity was higher at Post-Washout versus Pre-Control (p = .018) and Post-Control (p = .024), and at Post-GaitWay versus Pre-Control (p = .037). Upper-limb coordination was higher Post-GaitWay versus Post-Control (p = .050). When compared to Pre-Control, strength was higher at Post-EAA (p = .028) and at Post-GaitWay (p = .015). Overall scores were higher at Post-GaitWay when compared to Pre-Control (p = .003) and Post-Control (p = .009). Among the seven participants who participated in the 1-year follow-up GaitWay motor skills were maintained for one year following the Post-GaitWay testing session. A combination of EAA and brain building activities may be an effective therapeutic modality to improve and maintain motor skill proficiency in youth with ND.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Delay, Motor Skills Disorders, Autism Spectrum Disorder, Attention Deficit Hyper Activity, Intellectual Disability, Sensory Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care Provider
Masking Description
Therapists were blinded to the outcome measures and assessments used to obtain those outcome measures in this study
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control period; no equine-assisted activities or brain-building activities occurred
Arm Title
Equine-assisted activities period
Arm Type
Active Comparator
Arm Description
Period in which only equine-assisted activities were performed
Arm Title
Washout
Arm Type
No Intervention
Arm Description
Washout period; no equine-assisted activities or brain-building activities occurred
Arm Title
GaitWay period
Arm Type
Experimental
Arm Description
Period in which both equine-assisted activities and brain-building activities were performed
Intervention Type
Behavioral
Intervention Name(s)
Equine-assisted activities
Other Intervention Name(s)
EAA
Intervention Description
Participants performed riding-related activities on and off of a horse once per week for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
GaitWay program
Other Intervention Name(s)
GW
Intervention Description
Participants performed riding-related activities on and off of a horse, along with brain-building activities including balance tasks, swinging, spinning, music therapy, and sensory tasks, all once per week for 8 weeks
Primary Outcome Measure Information:
Title
Fine motor precision
Description
Subtest #1 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Tasks include drawing through lines, folding paper. Each task within this subtest is scored on a scale from 0-7 (with 7 representing the best outcome).
Time Frame
0-5 minutes
Title
Fine motor integration
Description
Subtest #2 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Task includes copying a star and a square. The task within this subtest is scored on a scale from 0-5 (with 5 representing the best outcome).
Time Frame
0-5 minutes
Title
Manual dexterity
Description
Subtest #3 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Task includes transferring pennies. The task within this subtest is scored on a scale from 0-9 (with 9 representing the best outcome).
Time Frame
15 seconds
Title
Bilateral coordination
Description
Subtest #4 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Tasks include jumping in place with arms and legs on same side of the body synchronized, and tapping feet and fingers simultaneously, with hands and feet on the same side of the body synchronized. The jumping task within this subtest is scored on a scale from 0-3 (with 3 representing the best outcome). The tapping task within this subtest is scored on a scale from 0-4 (with 4 representing the best outcome).
Time Frame
0-5 minutes
Title
Balance
Description
Subtest #5 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Tasks include walking forward on a line, standing on one leg on a balance beam with eyes open. Each task within this subtest is scored on a scale from 0-4 (with 4 representing the best outcome).
Time Frame
1 minute
Title
Running speed and agility
Description
Subtest #6 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Task includes one-legged stationary hop. The task within this subtest is scored on a scale from 0-10 (with 10 representing the best outcome).
Time Frame
15 seconds
Title
Upper-limb coordination
Description
Subtest #7 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Tasks include dropping and catching a ball with both hands, dribbling a ball with alternating hands. The dropping and catching task within this subtest is scored on a scale from 0-5 (with 5 representing the best outcome). The dribbling task within this subtest is scored on a scale from 0-7 (with 7 representing the best outcome).
Time Frame
0-5 minutes
Title
Strength
Description
Subtest #8 on the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Tasks include knee push-ups and sit-ups. Each task within this subtest is scored on a scale from 0-10 (with 10 representing the best outcome).
Time Frame
1 minute
Title
Overall Motor Skill Scores
Description
Sum of all scores from the 8 subtests of the Bruininks-Oseretsky Test of Motor Proficiency (Version 2) Short Form. Total scores can range from 0-88 (with 88 representing the best outcome)
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Caregiver reports
Description
Anecdotal reports from caregivers regarding progress of the participant
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 5 to 18 years
diagnosis of a neurodevelopmental disorder (as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5))
had the ability to follow verbal directions,
Clearance to participate from a medical professional
Exclusion Criteria:
a perfect score on the motor proficiency test at the first testing session
presence of seizures within the past 6 months controlled by medication
a known allergy to horses
any surgical procedures performed within the 6 months
regular horseback riding experience of any kind during the past year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon R Rigby, PhD
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data (IPD) may be shared by contacting the corresponding author for the study once it is published. All data related to motor skill tasks, including fine motor precision, fine motor integration, manual dexterity, bilateral coordination, balance, running speed and agility, upper-limb coordination, strength, and overall motor skill scores may be shared upon request.
Citations:
PubMed Identifier
32083104
Citation
Rigby BR, Davis RW, Bittner MD, Harwell RW, Leek EJ, Johnson GA, Nichols DL. Changes in Motor Skill Proficiency After Equine-Assisted Activities and Brain-Building Tasks in Youth With Neurodevelopmental Disorders. Front Vet Sci. 2020 Jan 31;7:22. doi: 10.3389/fvets.2020.00022. eCollection 2020.
Results Reference
derived
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Motor Skill Proficiency After Equine-assisted Activities and Brain-building Tasks
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