Voluntary driven exoskeleton as a new tool for rehabilitation in chronic spinal cord injury: a pilot study.

Background Context: Treadmill training after traumatic spinal cord injury (SCI) has become an established therapy to improve walking capabilities. The hybrid assistive limb (HAL) exoskeleton has been developed to support motor function and is tailored to the patients' voluntary drive.

Purpose: To determine whether locomotor training with the exoskeleton HAL is safe and can increase functional mobility in chronic paraplegic patients after SCI.

Design: A single case experimental A-B (pre-post) design study by repeated assessments of the same patients. The subjects performed 90 days (five times per week) of HAL exoskeleton body weight supported treadmill training with variable gait speed and body weight support.

Patient Sample: Eight patients with chronic SCI classified by the American Spinal Injury Association (ASIA) Impairment Scale (AIS) consisting of ASIA A (zones of partial preservation [ZPP] L3-S1), n=4; ASIA B (with motor ZPP L3-S1), n=1; and ASIA C/D, n=3, who received full rehabilitation in the acute and subacute phases of SCI.

Outcome Measures: Functional measures included treadmill-associated walking distance, speed, and time, with additional analysis of functional improvements using the 10-m walk test (10MWT), timed-up and go test (TUG test), 6-minute walk test (6MWT), and the walking index for SCI II (WISCI II) score. Secondary physiologic measures including the AIS with the lower extremity motor score (LEMS), the spinal spasticity (Ashworth scale), and the lower extremity circumferences.

Methods: Subjects performed standardized functional testing before and after the 90 days of intervention.

Results: Highly significant improvements of HAL-associated walking time, distance, and speed were noticed. Furthermore, significant improvements have been especially shown in the functional abilities without the exoskeleton for over-ground walking obtained in the 6MWT, TUG test, and the 10MWT, including an increase in the WISCI II score of three patients. Muscle strength (LEMS) increased in all patients accompanied by a gain of the lower limb circumferences. A conversion in the AIS was ascertained in one patient (ASIA B to ASIA C). One patient reported a decrease of spinal spasticity.

Conclusions: Hybrid assistive limb exoskeleton training results in improved over-ground walking and leads to the assumption of a beneficial effect on ambulatory mobility. However, evaluation in larger clinical trials is required.