A Pilot Feasibility Trial of an Upper Extremity Assistive System

Emma Hammelef; Saami J Zakaria; Sarah H Andersen; Thomas J Kelly 4th; Namrata Grampurohit; Mikael Avery; Alessandro Napoli; Mary Jane Mulcahey; Mijail Demian Serruya

doi:10.1016/j.arrct.2023.100308

A Pilot Feasibility Trial of an Upper Extremity Assistive System

Arch Rehabil Res Clin Transl. 2023 Oct 28;5(4):100308. doi: 10.1016/j.arrct.2023.100308. eCollection 2023 Dec.

Authors

Emma Hammelef¹, Saami J Zakaria¹, Sarah H Andersen¹, Thomas J Kelly 4th¹, Namrata Grampurohit², Mikael Avery^{1

3}, Alessandro Napoli¹, Mary Jane Mulcahey², Mijail Demian Serruya¹

Affiliations

¹ Raphael Center for Neurorestoration, Farber Institute for Neuroscience, Thomas Jefferson University, 130 S 9th Street, Suite 2400, Philadelphia, PA 19107.
² Center for Outcomes and Measurement, College of Rehabilitation Sciences, Thomas Jefferson University, 901 Walnut Street, Suite 642, Philadelphia, PA 19107.
³ Studio Krea, Collingswood, NJ.

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.

Keywords: Activities of daily living (ADLs); Hemiplegia; Neurological rehabilitation; Occupational therapy; Rehabilitation; Stroke.