Background

The reported prevalence of walking difficulties in MS is approximately 70%. Walking impairments impact physical activity level, increase risk of falls, and reduce quality of life. Various exoskeletons are being studied as an adjunct to traditional physical exercise therapy. We present data from our study using the HAL® exoskeleton, a neurologically controlled robotic exoskeleton activated by the users' bio-electrical signals, to help rehabilitation in SPMS, NMO, and non-MS patients. The interim analysis is part of an ongoing pilot study involving 30 patients over the course of 4 years.

Objectives

To establish the safety and effectiveness of intervention using the HAL® exoskeleton in the SPMS, NMO, and non-MS populations in functional outcomes after training, 6, and 12 months.

Methods

This is an ongoing single-center prospective pilot study that takes place at the Swedish Multiple Sclerosis Center gym.

It includes 14 Patients - Progressive ((n=8; SPMS (n=7), NMO (n=1)) and non-MS patients (n=6).

Patients underwent 48-60 sessions of treadmill training over an average of 15 weeks in a body weight-supporting harness using the HAL® exoskeleton under the supervision of physical therapists. Training sessions were customized for each individual and could include stretching, vibration, strengthening, pre-gait, and training with alternate assistive devices. Training in HAL® had a goal of 30 minutes of skilled gait training integrating form, speed, balance, decreased visual reliance and dual task attention of the 2 hr session.

The main outcome measures are the 10 Meter Walk Test (10MWT), Timed Up & Go (TUG), 6 Minute Walk, and the BERG Balance Scale.

Results

Patients completed sessions of treadmill training with no serious adverse events noted. Patients were categorized into 2 groups: progressive (SPMS/NMO) and non-MS patients. Both groups demonstrated a mean improvement in all functional outcomes. Patients in both groups improved from baseline at least 20% in all functional outcomes (range, 22%-41%). Patients from the SPMS/NMO group on average tended to improve more with a 34%, 41%, 35% and 24% improvement in the TUG, BERG, 10MWT, and 6MWT, respectively. Those in the non-MS group improved 22%, 26%, 28%, and 35% in these same measures. The gains continued to remain the same or improve over the 6 and 12 month post training periods. The SPMS/NMO patients had a higher rate of improvement.

Conclusions

HAL® treadmill training improves the rehabilitation of patients with SPMS, NMO, and non- MS patient populations. This continues in follow-up testing at 6, and 12 months. The intervention is safe, and, patients demonstrated improved walking performances over the course of training and follow-up.