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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04158960
Other study ID # 17959
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2015
Est. completion date May 31, 2018

Study information

Verified date November 2019
Source Texas Woman's University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Texas Woman's University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Caregiver reports Anecdotal reports from caregivers regarding progress of the participant 5 minutes
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