Motivating Occupational Virtual Experiences In Therapy for Kids

NCT04510857 | Completed Results FDA Device

• 2 other identifiers: MOVE-IT5R44HD092169-03
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Virtual Reality; Occupational Therapy

Keywords

Cerebral palsy; Occupational therapy; Virtual reality; Therapy games; Pediatric hemiplegia; Teletherapy

Outcome Measures

Primary Outcomes (2)

• Pre Jebsen Taylor Hand Function Test (JTHFT)

  The JTHFT assesses hand function through timed movements such as simulated page turning, eating, stacking objects, and lifting objects of different size and mass. The JTHFT total score is simply the sum of all timed movements (in seconds). A lower score represents a better outcome.

  Pre-intervention at Baseline

• Post Jebsen Taylor Hand Function Test (JTHFT)

  The JTHFT assesses hand function through timed movements such as simulated page turning, eating, stacking objects, and lifting objects of different size and mass. The JTHFT total score is simply the sum of all timed movements (in seconds). A lower score represents a better outcome.

  Post Intervention at 10 weeks

Secondary Outcomes (10)

• Pre Pediatric Motor Activity Log (Amount)

  Pre-intervention at Baseline

• Post Pediatric Motor Activity Log (Amount)

  Post Intervention at 10 weeks

• Pre Pediatric Motor Activity Log (How Well)

  Pre-intervention at Baseline

• Post Pediatric Motor Activity Log (How Well)

  Post Intervention at 10 weeks

• Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)

  Pre-intervention at Baseline

Study Arms (2)

MOVE-IT Home Exercise Program (HEP)

EXPERIMENTAL

Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.

Device: MOVE-IT Intervention

Usual Care Treatment (UCT) Control

ACTIVE COMPARATOR

Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.

Behavioral: UCT Control

Interventions

MOVE-IT Intervention DEVICE

The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.

MOVE-IT Home Exercise Program (HEP)

UCT Control BEHAVIORAL

Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.

Usual Care Treatment (UCT) Control

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of hemiplegia resulting from cerebral palsy, stroke, or other form of brain injury;
• Medically stable;
• Participant has antigravity strength in the affected UE at the elbow to at least 45 degrees of active flexion;
• Participant has antigravity shoulder strength in the affected UE to at least 30 degrees each in active flexion, abduction/adduction, and 15 degrees in active internal/external rotation when in an upright and seated position;
• Participant has ability to perform a basic color-matching test and identify characters on a vision chart;
• Participant must be available to attend study visits during an approximately 3-week participation period;
• Willingness and ability to comply with scheduled visits and study procedures.

You may not qualify if:

• History of uncontrolled seizures;
• Has received another form of intensive UE therapy, such as CIMT, within the prior 6 months;
• Unwillingness or inability to understand or follow verbal directions;
• Diagnosis of moderate to severe cortical-visual impairment that in the judgement of the Principal Investigator could adversely impact the subject's participation;
• Psychological diagnosis that in the determination of the Principal Investigator could significantly impact subject's participation or that could be aggravated by study participation;
• Determination that participation would result in over exertion, or significant discomfort or pain;
• Determination that participation would result in significant agitation or elevated stress;
• Visual field deficit in either eye that impairs the ability to view the computer monitor.

Sponsors & Collaborators

• Barron Associates, Inc.: lead
• University of Virginia: collaborator
• Duke University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Duke University

Durham, North Carolina, 27705, United States

Location

University of Virginia (UVA)

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Richard Adams
• Organization: Barron Associates, Inc.

adams@bainet.com

4348253435

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator administrating assessments will be blinded to subject group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intervention group performs home exercise program using the computer-aided MOVE-IT system for upper extremity therapy. Control group participants will be followed as they continue to receive their previously prescribed therapy services.

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: August 12, 2020
• Study Start: June 17, 2022
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)