ABSTRACT
Objective: To develop and clinically evaluate a customizable active upper extremity (UE) assistive system with integrated functional electrical stimulation (FES) that improves function and independence of individuals during activities of daily living (ADLs). Design: Single-arm, prospective, open-label cohort feasibility trial. Setting: An academic research institution. Participants: Subjects were 5 adults with a medical history of stroke resulting in distal UE impairment (N=5). The subjects volunteered from recruitment materials that detailed information about the study. Interventions: A novel, wearable, lightweight, low-profile, and patient-tailored UE assistive system. It comprises a splint component and FES unit that may each be controlled by electromyography (EMG) signals, inertial measurement units (IMUs), manual control source (joystick), and/or voice control. Main Outcome Measures: Several occupational therapy outcome measures were used, including the Canadian Occupational Performance Measure (COPM), Action Research Arm Test (ARAT), The Box and Blocks Test (BBT), the ABILHAND-Manual Ability Measure, and Patient Reported Outcomes Measurement Information System (PROMIS) UE Short Form. Results: All participants learned to use our UE assistive system to perform ADLs and were able to use it independently at home. Most participants experienced a clinically meaningful improvement in both performance and satisfaction for the majority of their COPM goals while using the system. All participants experienced improvement in hand grip and release as shown by their baseline and post assessment scores for hand function (BBT, ARAT) and patient-reported outcomes (ABILHAND, PROMIS). Conclusions: The clinical outcomes suggest that our UE assistive system improves functional performance in patients with UE impairment, allowing them to engage more actively in ADLs. Further innovation including elbow and shoulder components will allow users to have more degrees of freedom during tasks.
ABSTRACT
BACKGROUND: Ultrasound (U/S) guided peripheral IV catheter (PIV) placement is often needed after unsuccessful traditional IV attempts. Commercial U/S PIV training phantoms are expensive and difficult to alter. Non-commercial phantoms have been described; however, there has been no comparison of these models. The primary objectives of this study were to compare the echogenic and haptic properties of various non-commercial phantoms. Secondary objectives were to characterize the cost and ease of making the phantoms. METHODS: This prospective observational study trialed six unique phantom models: Amini Ballistics; Morrow Ballistics; University of California San Diego (UCSD) gelatin; Rippey Chicken; Nolting Spam; and Johnson Tofu. Total cost and creation time were noted. Emergency Ultrasound Fellowship trained physicians performed U/S guided PIV placement on each model to evaluate their resemblance to human tissue haptic and echogenicity properties, utility for training, and comparability to commercial phantoms (Likert scale 1-5; higher performance = 5). RESULTS: The Rippey model scored highest for each primary objective with an aggregate score of 4.8/5. UCSD ranked second and Nolting last for all primary objectives, with aggregate scores 3.7/5 and 1.3/5 respectively. Cost of production ranged from $4.39 (Johnson) to $29.76 (UCSD). Creation times ranged from 10 min (Johnson) to 120 min (UCSD). CONCLUSION: In our study the Rippey model performed best and offered a mid-level cost and creation time. Non-commercial U/S phantoms may represent cost-effective and useful PIV practice tools. Future studies should investigate the utility of these phantoms in teaching U/S guided PIV to novices and compare non-commercial to commercial phantoms.