Clinical trial NCT04510857: Motivating Occupational Virtual Experiences In Therapy for Kids
Official title: Motivating Occupational Virtual Experiences In Therapy for Kids (MOVE-IT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Occupational Therapy
Keywords: Cerebral palsy
Occupational therapy
Virtual reality
Therapy games
Pediatric hemiplegia
Teletherapy
Lead sponsor: Barron Associates, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Virginia
name: Duke University
First posted: 2020-08-12
Enrollment: 25
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Jebsen Taylor Hand Function Test (JTHFT)
timeFrame: 20 minutes
Secondary outcomes:
measure: Quality of Upper Extremity Skills Test (QUEST)
timeFrame: 20 minutes
measure: Pediatric Motor Activity Log
timeFrame: 10 minutes
measure: Wolf Motor Function Test - TIME (WMFT-TIME)
timeFrame: 10 minutes
measure: Wolf Motor Function Test - Functional Assessment (WMFT-FA)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Charlottesville
country: United States
facility: University of Virginia (UVA)
state: Virginia
Study officials:
References: