First report of a new exoskeleton in incomplete spinal cord injury: FreeGait®.

Context: Intensive walking practice often demands capabilities that go beyond the limits for both patients and therapists. As a solution, robot-assisted exoskeletons have been developed to deliver efficient rehabilitation sessions.

Objective: The primary aim was to evaluate the effect of adding exoskeleton training, the FreeGait®, to conventional treatment on walking status in patients with motor incomplete spinal cord injury. The secondary aim was to assess its impact on mobility, functional independence, and health-related quality of life.

Methods: This study compared exoskeleton gait training with conventional therapy (RBCT) versus conventional therapy alone (CT). Fourteen participants with motor incomplete spinal cord injury were included, with seven in each group. Both groups had 40-minute conventional therapy sessions 5 days a week. Additionally, the RBCT performed exoskeleton walking and balance exercises 3 days a week. The WISCI II (primary outcome), 10MWT, gait speed, TUG, BBS, SCIM III, and WHOQOL-BREF were used for evaluation (see text for acronyms).

Results: Walking status and mobility-related measures showed significant improvements in the RBCT (p < 0.05), whereas no significant differences were observed in the CT (p > 0.05). There was a significant difference in the physical health domain of the WHOQOL-BREF only in the RBCT. However, no significant differences were found in the WHOQOL-BREF total score in both groups (p > 0.05). Furthermore, no significant difference was observed between the groups in terms of change (p > 0.05).

Conclusions: Gait training with the new exoskeleton combined with conventional therapy, positively contributes to walking status, mobility, and functional independence.Trial registration: ClinicalTrials.gov identifier: NCT06137456.