An observational study evaluating the safety and efficacy of virtual reality-integrated somato-cognitive coordination therapy in pediatric and adolescent and young adult patients across a range of medical conditions

An observational study evaluating the safety and efficacy of virtual reality-integrated somato-cognitive coordination therapy in pediatric and adolescent and young adult patients across a range of medical conditions - VISION study: Virtual reality-Integrated Somato-cognitive coordinatION therapy in pediatric and adolescent and young adult(AYA) patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057736

Enrollment

Registered

2025-04-29

Start date

2025-04-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients under 40 years of age in the pediatric and AYA (Adolescent and Young Adult) populations presenting with physical or cognitive abnormalities.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients under 40 years of age in the pediatric and AYA (Adolescent and Young Adult) populations presenting with physical or cognitive abnormalities.

Exclusion criteria

Exclusion criteria: 1)??Patients deemed inappropriate for participation by the principal investigator or co-investigators. 2)??Patients who did not provide written informed consent.

Design outcomes

Primary

Measure	Time frame
Safety Assessment Adverse events during SCCT, including VR sickness, falls, and CTCAE Grade 3 or higher events. Possible efficacy such as therapeutic signals defined by the association between sysmptom improvement and intervention	—

Secondary

Measure	Time frame
Efficacy Assessment Changes in physical function at 1, 3, and 6 months after treatment initiation, or at the final follow-up. Changes in cognitive function at 1, 3, and 6 months after treatment initiation, or at the final follow-up. Changes in imaging findings at 1, 3, and 6 months after treatment initiation, or at the final follow-up. Changes in physiological function test results at 1, 3, and 6 months after treatment initiation, or at the final follow-up. Changes in Quality of Life (QOL) scores at 1, 3, and 6 months after treatment initiation, or at the final follow-up. Changes in outcome measures identified by the investigator as necessary at 1, 3, and 6 months after treatment initiation, or at the final follow-up.	—

Measure

Time frame

Efficacy Assessment Changes in physical function at 1, 3, and 6 months after treatment initiation, or at the final follow-up. Changes in cognitive function at 1, 3, and 6 months after treatment initiation, or at the final follow-up. Changes in imaging findings at 1, 3, and 6 months after treatment initiation, or at the final follow-up. Changes in physiological function test results at 1, 3, and 6 months after treatment initiation, or at the final follow-up. Changes in Quality of Life (QOL) scores at 1, 3, and 6 months after treatment initiation, or at the final follow-up. Changes in outcome measures identified by the investigator as necessary at 1, 3, and 6 months after treatment initiation, or at the final follow-up.

—

Countries

Japan

Contacts

Public ContactMasanobu Takeuchi

Yokohama City University Hospital Pediatrics

mtake@yokohama-cu.ac.jp045-787-2800

Outcome results