Mobility Skills With Exoskeletal-Assisted Walking in Persons With SCI: Results From a Three Center Randomized Clinical Trial

EunKyoung Hong; Peter H Gorman; Gail F Forrest; Pierre K Asselin; Steven Knezevic; William Scott; Sandra Buffy Wojciehowski; Stephen Kornfeld; Ann M Spungen

doi:10.3389/frobt.2020.00093

Mobility Skills With Exoskeletal-Assisted Walking in Persons With SCI: Results From a Three Center Randomized Clinical Trial

Front Robot AI. 2020 Aug 4:7:93. doi: 10.3389/frobt.2020.00093. eCollection 2020.

Authors

EunKyoung Hong^{1

2}, Peter H Gorman³, Gail F Forrest^{4

5}, Pierre K Asselin^{1

2}, Steven Knezevic¹, William Scott⁶, Sandra Buffy Wojciehowski^{4

7}, Stephen Kornfeld^{1

2}, Ann M Spungen^{1

2

8}

Affiliations

¹ Spinal Cord Damage Research Center, James J. Peters VA Medical Center, Bronx, NY, United States.
² Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
³ Department of Neurology, University of Maryland School of Medicine and Chief, Division of Rehabilitation Medicine, University of Maryland Rehabilitation and Orthopaedic Institute, Baltimore, MD, United States.
⁴ Center for Spinal Stimulation and Center for Mobility and Rehabilitation Engineering, Kessler Foundation, West Orange, NJ, United States.
⁵ Physical Medicine & Rehabilitation, Rutgers New Jersey Medical School, Newark, NJ, United States.
⁶ Department of Neurology, University of Maryland School of Medicine and VA Maryland Healthcare System, Baltimore, MD, United States.
⁷ Performance Exercise Attitude and Knowledge Center, Craig Hospital, Englewood, CO, United States.
⁸ Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, United States.

Abstract

Background: Clinical exoskeletal-assisted walking (EAW) programs for individuals with spinal cord injury (SCI) have been established, but many unknown variables remain. These include addressing staffing needs, determining the number of sessions needed to achieve a successful walking velocity milestone for ambulation, distinguishing potential achievement goals according to level of injury, and deciding the number of sessions participants need to perform in order to meet the Food and Drug Administration (FDA) criteria for personal use prescription in the home and community. The primary aim of this study was to determine the number of sessions necessary to achieve adequate EAW skills and velocity milestones, and the percentage of participants able to achieve these skills by 12 sessions and to determine the skill progression over the course of 36 sessions. Methods: A randomized clinical trial (RCT) was conducted across three sites, in persons with chronic (≥6 months) non-ambulatory SCI. Eligible participants were randomized (within site) to either the EAW arm first (Group 1), three times per week for 36 sessions, striving to be completed in 12 weeks or the usual activity arm (UA) first (Group 2), followed by a crossover to the other arm for both groups. The 10-meter walk test seconds (s) (10MWT), 6-min walk test meters (m) (6MWT), and the Timed-Up-and-Go (s) (TUG) were performed at 12, 24, and 36 sessions. To test walking performance in the exoskeletal devices, nominal velocities and distance milestones were chosen prior to study initiation, and were used for the 10MWT (≤ 40s), 6MWT (≥80m), and TUG (≤ 90s). All walking tests were performed with the exoskeletons. Results: A total of 50 participants completed 36 sessions of EAW training. At 12 sessions, 31 (62%), 35 (70%), and 36 (72%) participants achieved the 10MWT, 6MWT, and TUG milestones, respectively. By 36 sessions, 40 (80%), 41 (82%), and 42 (84%) achieved the 10MWT, 6MWT, and TUG criteria, respectively. Conclusions: It is feasible to train chronic non-ambulatory individuals with SCI in performance of EAW sufficiently to achieve reasonable mobility skill outcome milestones.

Keywords: 10MWT; 6MWT; Food and Drug Administration; TUG; exoskeletal-assisted walking; mobility walking tests.