N/A
N=21
Motivating Occupational Virtual Experiences In Therapy for Kids
Virtual Reality · Occupational Therapy
Bottom Line
View on ClinicalTrials.gov: NCT04510857 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Pre Jebsen Taylor Hand Function Test (JTHFT) — 433.9; 294.7 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MOVE-IT Intervention (Device); UCT Control (Behavioral)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Barron Associates, Inc.
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre Jebsen Taylor Hand Function Test (JTHFT) |
433.9; 294.7 | — |
| PRIMARY Post Jebsen Taylor Hand Function Test (JTHFT) |
416.6; 268.3 | — |
| SECONDARY Pre Pediatric Motor Activity Log (Amount) |
1.68; 2.30 | — |
| SECONDARY Post Pediatric Motor Activity Log (Amount) |
1.80; 2.23 | — |
| SECONDARY Pre Pediatric Motor Activity Log (How Well) |
1.68; 2.73 | — |
| SECONDARY Post Pediatric Motor Activity Log (How Well) |
2.25; 2.98 | — |
| SECONDARY Pre Intervention Wolf Motor Function Test Time (WMFT-TIME) |
24.3; 18.3 | — |
| SECONDARY Post Intervention Wolf Motor Function Test Time (WMFT-TIME) |
24.1; 24.9 | — |
| SECONDARY Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA) |
2.95; 3.40 | — |
| SECONDARY Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA) |
3.00; 3.63 | — |
| SECONDARY Pre Quality of Upper Extremity Skills Test (QUEST) |
67.5; 77.7 | — |
| SECONDARY Post Quality of Upper Extremity Skills Test (QUEST) |
65.3; 77.4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04510857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.