Wearable robotic exoskeleton for overground gait training in sub-acute and chronic hemiparetic stroke patients: preliminary results.

BACKGROUND: Recovery of therapeutic or functional ambulatory capacity in post-stroke patients is a primary goal of rehabilitation. Wearable powered exoskeletons allow patients with gait dysfunctions to perform over-ground gait training, even immediately after the acute event.

AIM: To investigate the feasibility and the clinical effects of an over-ground walking training with a wearable powered exoskeleton in sub-acute and chronic stroke patients.

DESIGN: Prospective, pilot pre-post, open label, non-randomized experimental study.

SETTING: A single neurological rehabilitation center for inpatients and outpatients.

POPULATION: Twenty-three post-stroke patients were enrolled: 12 sub-acute (mean age: 43.8±13.3 years, 5 male and 7 female, 7 right hemiparesis and 5 left hemiparesis) and 11 chronic (mean age: 55.5±15.9 years, 7 male and 4 female, 4 right hemiparesis and 7 left hemiparesis) patients.

METHODS: Patients underwent 12 sessions (60 min/session, 3 times/week) of walking rehabilitation training using Ekso™, a wearable bionic suit that enables individuals with lower extremity disabilities and minimal forearm strength to stand up, sit down and walk over a flat hard surface with a full weight-bearing reciprocal gait. Clinical evaluations were performed at the beginning of the training period (t0), after 6 sessions (t1) and after 12 sessions (t2) and were based on the Ashworth scale, Motricity Index, Trunk Control Test, Functional Ambulation Scale, 10-Meter Walking Test, 6-Minute Walking Test, and Walking Handicap Scale. Wilcoxon's test (P<0.05) was used to detect significant changes.

RESULTS: Statistically significant improvements were observed at the three assessment periods for both groups in Motricity Index, Functional Ambulation Scale, 10-meter walking test, and 6-minute walking test. Sub-acute patients achieved statistically significant improvement in Trunk Control Test and Walking Handicap Scale at t0-t2. Sub-acute and chronic patient did not achieve significant improvement in Ashworth scale at t0-t2.

CONCLUSIONS: Twelve sessions of over-ground gait training using a powered wearable robotic exoskeleton improved ambulatory functions in sub-acute and chronic post-stroke patients. Large, randomized multicenter studies are needed to confirm these preliminary data.

CLINICAL REHABILITATION IMPACT: To plan a completely new individual tailored robotic rehabilitation strategy after stroke, including task-oriented over-ground gait training.