Motivating Occupational Virtual Experiences In Therapy for Kids (MOVE-IT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Barron Associates, Inc.
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Pre Jebsen Taylor Hand Function Test (JTHFT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Investigator administrating assessments will be blinded to subject group assignment.
Eligibility Criteria
- Ages
- 4 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: MOVE-IT Intervention (Device)
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.
Intervention: UCT Control (Behavioral)
Outcomes
Primary Outcomes
Pre Jebsen Taylor Hand Function Test (JTHFT)
Time Frame: Pre-intervention at Baseline
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 Jebsen Taylor Hand Function Test (JTHFT)
Time Frame: Post Intervention at 10 weeks
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.
Secondary Outcomes
- 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)
- Post Intervention Wolf Motor Function Test Time (WMFT-TIME)(Post Intervention at 10 weeks)
- Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)(Pre-intervention at Baseline)
- Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)(Post Intervention at 10 weeks)
- Pre Quality of Upper Extremity Skills Test (QUEST)(Pre-intervention at Baseline)
- Post Quality of Upper Extremity Skills Test (QUEST)(Post Intervention at 10 weeks)