ALS is a progressive neurodegenerative disease that affects the motor neurons in the brain and spinal cord. Motor neuron injury causes weakness and loss of strength in the muscles associated with movements of the extremities, swallowing, speaking, and breathing. The prognosis is poor with short survival ranging from 3 to 5 years, and currently no treatment is available to control disease progression. Therefore, ALS is often referred to as the ‘most intractable of the intractable diseases.’ Riluzole and edaravone are covered by insurance for management of ALS. However, these drugs do not reduce muscle weakness or emaciation; therefore, patients may not usually perceive symptomatic improvement. In 2018, the Division of Neurology, Department of Internal Medicine, Toho University Faculty of Medicine introduced a medical HAL for treatment of ALS to improve walking function. HAL application for neuromuscular diseases including ALS (eight diseases overall) was covered by insurance in Japan in April 2016. However, only 1 of 24 patients with ALS was treated in clinical trials; therefore, further research is warranted to definitively establish the effectiveness of HAL for ALS.
The study included 11 patients who were unable to walk safely independently over >10 m but could cover this distance with assistance or with the use of a walking aid and were diagnosed with ALS at Toho University Omori Medical Center between January and December 2019. Evaluation consisted of one cool of HAL treatment (overall 9 sessions, 2–3 sessions/week for 1-2 months, with a maximum of 2 sessions/week). Effectiveness of HAL therapy was determined based on results of the 2-min walking distance, 10-m walk test (speed, stride length, and walking rate were measured), the Revised ALS Functional Assessment Scale (ALSFRS-R), Barthel Index (BI), functional independence index (FIM), and pre- and post-intervention effort lung capacity (duration of 20–40 min excluding wear and breaks). Our results showed that the mean walking distance increased from 73.87 m before treatment to 89.94 m after treatment (p=0.004), and the mean walking rate for the 10-m walk also improved from 1.71 before treatment to 1.81 after treatment (p=0.04). Although no significant differences were observed, the speed and stride length of the 10-m walk also showed a trend toward improvement, whereas the ALSFRS-R, BI, and FIM scores were maintained. Gait dysfunction reduces activities of daily living and QOL in patients with ALS. Continuous HAL therapy may maintain and improve gait function in patients with ALS; however, further research is warranted to conclusively establish these findings.