Motor DelayNCT04158960
Motor Skill Proficiency After Equine-assisted Activities and Brain-building Tasks
A study testing Equine-assisted activities and GaitWay program in people with Motor Delay and Motor Skills Disorders, run by Texas Woman's University.
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). Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Motor Delay, Motor Skills Disorders, Autism Spectrum Disorder
- What is being tested?
- Equine-assisted activities and GaitWay program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2015to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Changes in Motor Skill Proficiency After Equine-Assisted Activities and Brain-Building Tasks in Youth With Neurodevelopmental Disorders
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.
Read the 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.
- Conditions
- Motor Delay, Motor Skills Disorders, Autism Spectrum Disorder, Attention Deficit Hyper Activity, Intellectual Disability, Sensory Disorders
- Being tested
- Equine-assisted activities, GaitWay program
- Medical subject headings
- Psychomotor Disorders, Motor Skills Disorders, Autism Spectrum Disorder, Intellectual Disability, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equine-assisted activitiesBehavioural
Also called EAA
Participants performed riding-related activities on and off of a horse once per week for 8 weeks
GaitWay programBehavioural
Also called GW
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: GaitWay program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 2 minutes
Secondary outcomes (1)
Caregiver reports
Anecdotal reports from caregivers regarding progress of the participant
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start1 Feb 2015
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rhett Rigby, Texas Woman's University
- Investigators
- Brandon R Rigby, PhD, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158960
- Sponsor's protocol ID
- 17959
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32083104
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Motor Skill Proficiency After Equine-Assisted Activities and Brain-Building Tasks in Youth With Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT04158960
- Acronym / sponsor ID
- 17959
- Conditions
- Motor Delay, Motor Skills Disorders, Autism Spectrum Disorder, Attention Deficit Hyper Activity, Intellectual Disability, Sensory Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control period; no equine-assisted activities or brain-building activities occurred |
| Equine-assisted activities period | Active comparator | Behavioral: Equine-assisted activitiesPeriod in which only equine-assisted activities were performed |
| Washout | No intervention | –Washout period; no equine-assisted activities or brain-building activities occurred |
| GaitWay period | Experimental | Behavioral: GaitWay programPeriod in which both equine-assisted activities and brain-building activities were performed |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Equine-assisted activitiesAlso: EAAParticipants performed riding-related activities on and off of a horse once per week for 8 weeks | Behavioural | Equine-assisted activities period |
| GaitWay programAlso: GWParticipants 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 | Behavioural | GaitWay period |
Primary outcome
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).
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).
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).
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).
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).
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).
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).
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).
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)
1 secondary outcome
Caregiver reports
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Derived from this study: PubMed 32083104Rigby 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon R Rigby, PhD principal investigator
Texas Woman's University
Questions about this trial
What is this clinical trial studying?
A study testing Equine-assisted activities and GaitWay program in people with Motor Delay and Motor Skills Disorders, run by Texas Woman's University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fine motor precision (time frame: 0-5 minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04158960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.