NCT04158960

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
Last Updated

November 12, 2019

Status Verified

November 1, 2019

Enrollment Period

3.3 years

First QC Date

November 5, 2019

Last Update Submit

November 6, 2019

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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).

    0-5 minutes

  • 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).

    0-5 minutes

  • 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).

    15 seconds

  • 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).

    0-5 minutes

  • 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).

    1 minute

  • 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).

    15 seconds

  • 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).

    0-5 minutes

  • 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).

    1 minute

  • 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)

    2 minutes

Secondary Outcomes (1)

  • Caregiver reports

    5 minutes

Study Arms (4)

Control

NO INTERVENTION

Control period; no equine-assisted activities or brain-building activities occurred

Equine-assisted activities period

ACTIVE COMPARATOR

Period in which only equine-assisted activities were performed

Behavioral: Equine-assisted activities

Washout

NO INTERVENTION

Washout period; no equine-assisted activities or brain-building activities occurred

GaitWay period

EXPERIMENTAL

Period in which both equine-assisted activities and brain-building activities were performed

Behavioral: GaitWay program

Interventions

Participants performed riding-related activities on and off of a horse once per week for 8 weeks

Also known as: EAA
Equine-assisted activities period
GaitWay programBEHAVIORAL

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

Also known as: GW
GaitWay period

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychomotor DisordersMotor Skills DisordersAutism Spectrum DisorderIntellectual DisabilitySensation Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersChild Development Disorders, Pervasive

Study Officials

  • Brandon R Rigby, PhD

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Therapists were blinded to the outcome measures and assessments used to obtain those outcome measures in this study
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 12, 2019

Study Start

February 1, 2015

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

November 12, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

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.