Disclosures: Ann M. Spungen, EdD: No financial relationships or conflicts of interest
Objective : To report eligibility screening and participant completion/withdrawal results from two different multicenter trials for exoskeletal-assisted walking (EAW) and the associated complications/successes in conducting this research.
Design: Descriptive report of two separate randomized controlled trials.
Setting : Three Rehabilitation/Medical Centers and 15 VA Medical Centers
Participants : Persons with spinal cord injury (SCI) >6 months who were wheelchair users for mobility. One investigation included 50 participants over 3 sites and the other investigation included 100 participants over 15 sites.
Interventions: 36 sessions of EAW and 20-30 sessions of EAW followed by 4 months of home-use of a powered exoskeleton
Main Outcome Measures: Number and reasons for screen failures and study withdrawals; number and types of adverse events.
Results: In the 3-site trial: 104 were consented/screened, 71 were randomized and 50 completed 36 sessions of EAW. Of the screen failures (33/104), the top 5 causes were: 1) low bone mineral density (BMD) or fracture history (15/104, 14%), 2) schedule conflicts (7/104, 7%), 3) contractures (5/104, 5%), 4) level of SCI or weight (3/104, 3%) and 5) medical complications (2/104, 2%). The reasons for withdraws (21/71, 30%): compliance/schedule conflicts (14/71, 20%) and medical problems (7/71, 10%). In the 15-site trial (to date): 294 were consented/screened, 38 declined to continue, 100 were randomized and 151 screen-failed. Reasons for screen failures were: 1) fracture history/low BMD (75/294, 25.5%), 2) contracture/spasticity (37/294, 12.6%), 3) anthropometric/weight (29/294, 9.9%), 4) failed EAW basic skills test (23/294, 7.8%), 5) medical complications (21/294, 7.1%), 6) level of SCI/neurological status (19/294, 6.5%), 7) no companion/home not suitable (n=16 5.4%), and 8) physician discretion (7/294 2.4%).
Conclusions: The most frequent contraindications found for EAW were fracture history or low BMD. Using standardized screening for hip and knee BMD measurements across all sites, no study-related long bone fractures occurred; but two calcaneal fractures presented during first training sessions.
Level of Evidence: Level I
To cite this abstract in AMA style:
Spungen AM, Asselin PK. Indications and Contraindications for Exoskeletal-Assisted Walking in Persons with Spinal Cord Injury Using Evidence-Based Data [abstract]. PM R. 2020; 12(S1)(suppl 1). https://pmrjabstracts.org/abstract/indications-and-contraindications-for-exoskeletal-assisted-walking-in-persons-with-spinal-cord-injury-using-evidence-based-data/. Accessed June 5, 2025.« Back to AAPM&R Annual Assembly 2020
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/indications-and-contraindications-for-exoskeletal-assisted-walking-in-persons-with-spinal-cord-injury-using-evidence-based-data/