Motivating Occupational Virtual Experiences In Therapy for Kids

NCT ID: NCT04510857

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-17
• Study Completion Date: 2024-06-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MOVE-IT Home Exercise Program (HEP)

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.

Group Type: EXPERIMENTAL

MOVE-IT Intervention

Intervention Type: DEVICE

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

Usual Care Treatment (UCT) Control

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.

Group Type: ACTIVE_COMPARATOR

UCT Control

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: DEVICE

UCT Control

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Barron Associates, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University

Durham, North Carolina, United States

University of Virginia (UVA)

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5R44HD092169-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MOVE-IT

Identifier Type: -

Identifier Source: org_study_id