Motivating Occupational Virtual Experiences In Therapy for Kids

Virtual Reality Clinical Trial

— MOVE-IT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04510857
• Other study ID #: MOVE-IT
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: June 15, 2024

Study information

• Verified date: June 2023
• Source: Barron Associates, Inc.
• Contact: Richard J Adams, Ph.D.
• Phone: 4348253435
• Email: adams[@]bainet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• Diagnosis of hemiplegia resulting from cerebral palsy, stroke, or other form of brain injury;

• Medically stable;

• Gross Motor Functional Classification System (GMFCS) rating between I and IV; indicating the child can maintain antigravity head and trunk postures and exercise controlled arm movements;

• Manual Abilities Classification System (MACS) rating between II and V; indicating the child experiences mild to severe difficulty in handling objects with the affected hand;

• Communication Functional Classification System (CFCS) rating between I and III; indicating the child usually communicates effectively with familiar communication partners, but not unfamiliar partners, in most environments;

• 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 botulinum toxin injections, stem cell infusions or 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.

Related Conditions & MeSH terms

• Occupational Therapy
• Virtual Reality

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia (UVA)	Charlottesville	Virginia
United States	Duke University	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Barron Associates, Inc.	Duke University, University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Jebsen Taylor Hand Function Test (JTHFT)	Time-based measure of functional hand motor skills	20 minutes
Secondary	Quality of Upper Extremity Skills Test (QUEST)	Aggregate score based on individual scores for dissociated movements and grasp components	20 minutes
Secondary	Wolf Motor Function Test - TIME (WMFT-TIME)	WMFT-TIME is a quantitative measure calculated using the average time to complete the individual tasks within the WMFT.	10 minutes
Secondary	Pediatric Evaluation and Disability Inventory Computer Adaptive Test (PEDI-CAT)	Parental report instrument of upper extremity motor function	10 minutes
Secondary	Pediatric Motor Activity Log	Parental report instrument of upper extremity motor function	10 minutes
Secondary	Wolf Motor Function Test - Functional Assessment (WMFT-FA)	WMFT Functional Assessment (FA) score is a qualitative assessment based on scoring of each functional task using a 6-point ordinal rating scale that ranges from 0 (no use of the affected hand attempted) to 5 (normal function). A total WMFT-FA is calculated by taking the average across all tasks.	10 minutes