NCT02358317

Brief Summary

The purpose of this pilot study is to determine whether a video-game based motor training can affect postural stability, daily living skills, autism symptoms, and white matter microstructure of the corticospinal tract in adolescents with Autism Spectrum Disorder (ASD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2019

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

4.2 years

First QC Date

February 3, 2015

Last Update Submit

June 10, 2019

Conditions

Autistic Disorder

Keywords

AutismPostural StabilityExergamingWhite Matter

Outcome Measures

Primary Outcomes (3)

  • Balance Time

    6 weeks

  • Postural Stability

    Center of Pressure Measurements from Wii Balance Board

    6 weeks

  • White matter microstructure of the Corticospinal tract

    White matter microstructure of the Corticospinal tract, as measured through Diffusion Weighted Imaging

    6 weeks

Secondary Outcomes (2)

  • Adaptive Daily Living Skills

    6 weeks

  • Social Responsiveness

    6 weeks

Study Arms (2)

Video Game Motor Training

EXPERIMENTAL

Participants in the treatment group will come to the University of Wisconsin lab for six weeks to train 3-5 days each week under research staff supervision. Each training session will last 30-60 minutes and will include playing our in-house Ninja Training game combined with balance games from the Wii Fit.

Behavioral: Video Game Motor Training

Sedentary Video Game Training

ACTIVE COMPARATOR

Participants randomly assigned to this condition will come to the lab for six weeks to play sedentary video games 3-5 days each week under research staff supervision. Each training session will last 30-60 minutes. Pre-and post assessments will be done identically to the Experimental group.

Behavioral: Sedentary Video Game Training

Interventions

Video Game Motor TrainingBEHAVIORAL
Video Game Motor Training
Sedentary Video Game TrainingBEHAVIORAL
Sedentary Video Game Training

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Previous diagnosis of Autism Spectrum Disorder (ASD)
  • Meet criteria for ASD on the Autism Diagnostic Observation Scale (ADOS) and Social Communication Questionnaire (SCQ).

You may not qualify if:

  • Co-occuring tuberous sclerosis, fragile X, a history of severe head injury, intellectual disability (IQ\<70), or hypoxia-ischemia.
  • Participants will not be able to be already engaged in more than 2 hours/week of balance training activities (i.e., yoga, tai chi, Wii/Kinect balance games) at study start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Waisman Center, University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (4)

  • Travers BG, Powell PS, Klinger LG, Klinger MR. Motor difficulties in autism spectrum disorder: linking symptom severity and postural stability. J Autism Dev Disord. 2013 Jul;43(7):1568-83. doi: 10.1007/s10803-012-1702-x.

    PMID: 23132272BACKGROUND

  • Deoni SC, Rutt BK, Arun T, Pierpaoli C, Jones DK. Gleaning multicomponent T1 and T2 information from steady-state imaging data. Magn Reson Med. 2008 Dec;60(6):1372-87. doi: 10.1002/mrm.21704.

    PMID: 19025904BACKGROUND

  • Alexander AL, Hurley SA, Samsonov AA, Adluru N, Hosseinbor AP, Mossahebi P, Tromp do PM, Zakszewski E, Field AS. Characterization of cerebral white matter properties using quantitative magnetic resonance imaging stains. Brain Connect. 2011;1(6):423-46. doi: 10.1089/brain.2011.0071. Epub 2012 Jan 27.

    PMID: 22432902BACKGROUND

  • Zhang H, Schneider T, Wheeler-Kingshott CA, Alexander DC. NODDI: practical in vivo neurite orientation dispersion and density imaging of the human brain. Neuroimage. 2012 Jul 16;61(4):1000-16. doi: 10.1016/j.neuroimage.2012.03.072. Epub 2012 Mar 30.

    PMID: 22484410BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Brittany G Travers, Ph.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 6, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2019

Study Completion

May 24, 2019

Last Updated

June 11, 2019

Record last verified: 2019-06

Locations

US(1)