NCT04510857

Motivating Occupational Virtual Experiences In Therapy for Kids

Motivating Occupational Virtual Experiences In Therapy for Kids (MOVE-IT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Barron Associates, Inc. · Industry
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

A rater-blinded randomized controlled trial (RCT) will be conducted to compare the efficacy of MOVE-IT use in a remotely supervised home exercise program (HEP) to usual care for recovery of upper extremity (UE) function in children with hemiplegia.

Detailed description

A rater-blinded randomized controlled trial (RCT) will be conducted to compare the efficacy of MOVE-IT use in a remotely supervised home exercise program (HEP) to usual care for recovery of upper extremity (UE) function in children with hemiplegia, and to acquire evidence of usability and acceptance of the MOVE-IT system by children and parents. The University of Virginia (UVA) will serve as coordinating center and single IRB for the two-site RCT that includes UVA and Duke University. The primary Phase II investigational objective is to show a differential effect on the pre- to post-intervention change in UE motor function between an interventional group receiving the MOVE-IT HEP and a usual care treatment (UCT) group, as assessed by the Jebsen Tailor Hand Function Test (JTHFT), a time-based measure of functional hand motor skills, and other gold-standard clinical instruments for UE function including the Quality of Upper Extremity Skills Test (QUEST), with qualitative assessment of discrete movements, and the Wolf Motor Function Test (WMFT), which includes both quantitative and qualitative assessment of functional movements. The pre-to-post intervention change in the composite JTHFT score will be the primary endpoint for the Phase II efficacy study. Secondary analysis will include pre-to-post intervention changes in the composite QUEST and WMFT scores.

Conditions

• Virtual Reality
• Occupational Therapy

Interventions

Type	Name	Description
DEVICE	MOVE-IT Intervention	The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.
BEHAVIORAL	UCT Control	Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.

Timeline

• Start date: 2022-06-17
• Primary completion: 2024-06-15
• Completion: 2024-06-15
• First posted: 2020-08-12
• Last updated: 2025-10-15
• Results posted: 2025-10-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study