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Motor Skill Proficiency After Equine-assisted Activities and Brain-building Tasks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158960
Recruitment Status : Completed
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Rhett Rigby, Texas Woman's University

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.

Condition or disease Intervention/treatment Phase
Motor Delay Motor Skills Disorders Autism Spectrum Disorder Attention Deficit Hyper Activity Intellectual Disability Sensory Disorders Behavioral: Equine-assisted activities Behavioral: GaitWay program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Care Provider)
Masking Description: Therapists were blinded to the outcome measures and assessments used to obtain those outcome measures in this study
Primary Purpose: Treatment
Official Title: Changes in Motor Skill Proficiency After Equine-Assisted Activities and Brain-Building Tasks in Youth With Neurodevelopmental Disorders
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018


Arm Intervention/treatment
No Intervention: Control
Control period; no equine-assisted activities or brain-building activities occurred
Active Comparator: Equine-assisted activities period
Period in which only equine-assisted activities were performed
Behavioral: Equine-assisted activities
Participants performed riding-related activities on and off of a horse once per week for 8 weeks
Other Name: EAA

No Intervention: Washout
Washout period; no equine-assisted activities or brain-building activities occurred
Experimental: GaitWay period
Period in which both equine-assisted activities and brain-building activities were performed
Behavioral: GaitWay program
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
Other Name: GW




Primary Outcome Measures :
  1. Fine motor precision [ Time Frame: 0-5 minutes ]
    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).

  2. Fine motor integration [ Time Frame: 0-5 minutes ]
    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).

  3. Manual dexterity [ Time Frame: 15 seconds ]
    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).

  4. Bilateral coordination [ Time Frame: 0-5 minutes ]
    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).

  5. Balance [ Time Frame: 1 minute ]
    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).

  6. Running speed and agility [ Time Frame: 15 seconds ]
    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).

  7. Upper-limb coordination [ Time Frame: 0-5 minutes ]
    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).

  8. Strength [ Time Frame: 1 minute ]
    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).

  9. Overall Motor Skill Scores [ Time Frame: 2 minutes ]
    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 :
  1. Caregiver reports [ Time Frame: 5 minutes ]
    Anecdotal reports from caregivers regarding progress of the participant



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158960


Sponsors and Collaborators
Texas Woman's University
Investigators
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Principal Investigator: Brandon R Rigby, PhD Texas Woman's University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rhett Rigby, Associate Professor, Texas Woman's University
ClinicalTrials.gov Identifier: NCT04158960    
Other Study ID Numbers: 17959
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intellectual Disability
Sensation Disorders
Disease
Autism Spectrum Disorder
Motor Skills Disorders
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Child Development Disorders, Pervasive
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms