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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
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motor Delay

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 5, 2019
    Last Updated
    November 6, 2019
    Sponsor
    Texas Woman's University
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    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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