Feasibility, safety, and functional outcomes using the neurological controlled Hybrid Assistive Limb exoskeleton (HAL®) following acute incomplete and complete spinal cord injury - Results of 50 patients

Mirko Aach; Thomas Armin Schildhauer; Amrei Zieriacks; Oliver Jansen; Martin Weßling; Alexis Brinkemper; Dennis Grasmücke

doi:10.1080/10790268.2023.2200362

Feasibility, safety, and functional outcomes using the neurological controlled Hybrid Assistive Limb exoskeleton (HAL®) following acute incomplete and complete spinal cord injury - Results of 50 patients

J Spinal Cord Med. 2023 Jul;46(4):574-581. doi: 10.1080/10790268.2023.2200362. Epub 2023 Apr 21.

Authors

Mirko Aach¹, Thomas Armin Schildhauer², Amrei Zieriacks¹, Oliver Jansen², Martin Weßling³, Alexis Brinkemper², Dennis Grasmücke¹

Affiliations

¹ Department of Spinal Cord Injuries, BG University Hospital Bergmannsheil, Bochum, Germany.
² Department of General and Trauma Surgery, BG University Hospital Bergmannsheil, Bochum, Germany.
³ Department of Tumor- and Revision Surgery, Orthopaedic Hospital Volmarstein, Wetter, Germany.

Abstract

Objective: Recent studies reveal that Hybrid Assistive Limb (HAL®) locomotion training in paraplegic patients suffering from chronic spinal cord injury (SCI) induces improvements in functional and ambulatory mobility. The purpose of this study was to determine the safety, feasibility, and functional effectiveness of HAL® locomotion training in the initial rehabilitation of acute SCI patients. This clinical trial represents the first systematic intervention worldwide for acute SCI patients using a neurologically controlled exoskeleton.

Design: Single center, prospective study.

Setting: BG University Hospital Bergmannsheil, Bochum, Germany.

Participants: Fifty acute SCI patients (14 women, 36 men).

Interventions: All participants received a daily (5 times/week) HAL® exoskeleton supported training for 12 weeks (mean amount of training sessions 60.4 ± 30.08).

Outcome measures: Functional outcome for overground walking was monitored using the 10-m-walk test (10 MWT) combined with the WISCI II score, 6-minute-walk test (6 MWT) and the timed-up and go test (TUG test). Treadmill-related parameters (speed, distance and walking time) and the Lower Extremity Motor Score (LEMS) were recorded separately.

Results: Significant improvements were observed for HAL®-associated (walking time, distance and speed) and for functional outcomes (10 MWT, 6 MWT and TUG-test). WISCI-II-Score and the LEMS increased significantly compared with the status prior to training.

Conclusion: HAL® locomotion training is feasible and safe in the rehabilitation of acute SCI patients. The HAL® exoskeleton enables the patient to perform effective treadmill training and leads to improvements in functional and ambulatory mobility. However, spontaneous recovery vs training-related effects remain unclear and findings should not be extrapolated beyond the acute in-patient rehabilitation setting.Trial registration: German Clinical Trials Register identifier: DRKS00010250..

Keywords: Acute spinal cord injury; Exoskeleton; Hybrid Assistive Limb; Locomotion; Rehabilitation.

Publication types

Clinical Trial
Research Support, Non-U.S. Gov't

MeSH terms

Exercise Therapy
Exoskeleton Device*
Feasibility Studies
Female
Humans
Male
Paraplegia / rehabilitation
Prospective Studies
Spinal Cord Injuries* / rehabilitation
Walking

Associated data

ClinicalTrials.gov/DRKS00010250

Grants and funding

This work was supported by the New Energy and Industrial Technology Development Organization, Japan (NEDO) [grant number not available] and a governmental grant (I&K-Gender-Study/European-Union and NRW/Germany under grant number 005-GW02-069B). The trial has been exclusively performed and supervised by the staff of BG University Hospital Bergmannsheil Bochum.