NCT07134569

Brief Summary

The goal of this clinical trial is to learn if autism affect motor functions, including muscle strength, balance, and motor control? Additionally, understanding the motor functions, cognitive functions, and brain activation in individuals with autism, and verifying whether motor training can effectively improve muscle strength, balance, and motor control. The main questions aim to answer are: \[primary hypothesis or outcome measure 1\]? \[primary hypothesis or outcome measure 2\]? If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\]. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Dec 2023Jul 2027

Study Start

First participant enrolled

December 15, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

3.6 years

First QC Date

February 4, 2025

Last Update Submit

January 9, 2026

Conditions

Keywords

Virtual Realitymotor training

Outcome Measures

Primary Outcomes (2)

  • The performance of movement operational assessment

    Participants will take movement operational assessment, which composed of different tests, such as Timed Up and Go Test (TUG), the 10-meter walk test (10MWT) and the 6-minute walk test (6WMT)

    40 minutes

  • The performance of motor coordination control

    the performance recorded with Vicon, an motion capture system, and Single Leg Stance Test

    1 hour, twice

Secondary Outcomes (4)

  • The N-back Task performance

    40 minutes

  • The performance of Timed Up and Go Test (TUG)

    1 minute, twice

  • The performance of the 10-meter walk test (10MWT)

    1 minute, twice

  • The performance of 6-minute walk test (6WMT)

    6 minutes, twice

Study Arms (2)

Autism

EXPERIMENTAL
Behavioral: VR-based motor training

Typically developing control

NO INTERVENTION

Interventions

Six weeks, twice per week.

Autism

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • young adult aged between 18 and 45 years who had a diagnosis of ASD from a licensed mental health or medical professional based on DSM-5.
  • was motivated to complete the 6-week VR-based motor function training.
  • had a full-scale IQ \> 70 on the WAIS-IV.

You may not qualify if:

  • a history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis), neurological diseases (e.g., stroke, lumbar radiculopathy, or spinal cord injury) that hamper walking function, or neurosurgery.
  • visual impairment and/or hearing impairment that would preclude participation in motor assessment or training.
  • The Non-ASD control group
  • young adult aged between 18 and 45 years who do not have a diagnosis of ASD.
  • had a full-scale IQ \> 70 on the WAIS-IV.
  • a history of major mental illness (e.g., bipolar affective disorder, schizophrenia, or psychosis), neurological diseases (e.g., stroke, lumbar radiculopathy, or spinal cord injury), or neurosurgery that hamper walking function.
  • visual impairment and/or hearing impairment that would preclude participation in motor assessment or training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Yi Ling Chien, Clinical Professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 4, 2025

First Posted

August 21, 2025

Study Start

December 15, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

January 12, 2026

Record last verified: 2025-12

Locations