Investigative and Usability findings of the Move-D Orthotic Brace Prototype for Upper Extremity Tremors in Pediatric Patients: An unblinded, experimental study.

Research Objectives: To investigate efficacy of Move-D brace in improving upper extremity tremor.

Design: This pre-post test unblinded study conducted 5/29-9/18/2021 used Bruininks Oseretsky Test of Motor Proficiency, second edition (BOT-2); fine motor, manual dexterity, and upper limb coordination subtests to measure performance. Participants completed two trials, once while wearing the Move-D brace and once without. Even-numbered participants completed the first trial while wearing the brace and the second trial without. Following BOT-2 assessment, participants completed usability questionnaire. All data was collected on testing day and no follow-up was needed.

Setting: Assessments were conducted in a research exam room at Children's Health of Orange County (CHOC).

Participants: Twelve eligible participants 14-19 years old with mild to moderate tremors in their dominant upper extremity met criteria with 10 enrolling and 2 opting out. All 10 participants completed the study without adverse effects.

Interventions: Participants were assessed with and without the use of the brace using a subset of BOT-2 tests.

Main Outcome Measures: BOT-2 age equivalent scores in the three subtests and percentile scores were compared from baseline/control data (results of testing without assistance) to experimental data (results of testing when wearing the brace) using one-sided t-tests of mean differences.

Results: Statistically significant improvements in age equivalent scores in fine motor precision 20.5 (-3.8,44.8) months and upper limb coordination 15.1(2.4,27.8) months and manual coordination percentile rankings 2.9%(-1.3%,7.1%) were seen with the Move-D brace. Manual dexterity performance was unaffected. The usability survey revealed that 7/10 participants agreed or strongly agreed that they could move their arm freely while wearing brace, brace reduced their tremors, and they felt comfortable wearing brace at home.

Conclusions: Through standardized testing and findings from usability survey, Move-D showed improvement of functional abilities in a pediatric population with tremors. This study is limited by the small sample size, wide variability in effects, and the cohort imbalance between male and females, which may limit generalizability.

Author(s) Disclosures: Authors Li, Moss, and Taraman are inventors and hold intellectual property related to the Move-D brace.