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Powered Exoskeleton-Assisted Walking in Persons With Spinal Cord Injury
Sponsor: IRCCS San Raffaele Roma
Summary
Spinal Cord Injury (SCI) represents a significant health challenge, particularly when it comes to the ability to walk. Among its many consequences, mobility impairment can not only directly impact quality of life but also cause a series of secondary problems, such as urinary tract problems, breathing difficulties, muscle contractures, joint stiffness, and resulting pain. These effects can manifest early, even at a young age, further increasing the physical and psychological burden of those affected. To address these challenges, the use of overground exoskeletons, such as the Ekso Bionics (USA), has attracted growing interest in both scientific research and clinical practice. The Ekso not only offers mobility but also represents a valuable resource for gait training, with potential direct and indirect benefits for the physical health and overall well-being of people with SCI. This study is a multicenter, retrospective, pre-post cohort study with the aim of evaluating the dose-dependent effects of exoskeleton-assisted walking training on level ground on spasticity and functional independence in individuals with spinal cord injury. The sample includes at least 70 participants with SCI underwed at least five sessions of walking training using the Ekso™ exoskeleton. Primary outcomes included changes in spasticity, measured by the aggregated Modified Ashworth Scale (MAS), and functional independence, assessed by the Spinal Cord Independence Measure (SCIM) III. The ultimate aim is therefore to evaluate whether ground-based exoskeleton-assisted gait training effectively reduces spasticity and improves functional independence in individuals with spinal cord injury, as this can support the integration of wearable motorized exoskeleons into standard spinal cord injury rehabilitation protocols.
Official title: Multicenter Retrospective Observational Study on Gait Training With a Powered Overground Exoskeleton in Persons With Spinal Cord Injury
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
74
Start Date
2024-09-01
Completion Date
2026-05-15
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
Wearable Powered Exoskeleton
Participants underwent overground gait training using the EksoGT™ wearable powered exoskeleton (Ekso Bionics, Richmond, CA, USA) as part of a multidisciplinary rehabilitation program. Exoskeleton-assisted gait training sessions were conducted under therapist supervision three times per week, with each session lasting approximately 60 minutes. The device was individually fitted and calibrated according to participant anthropometric characteristics and motor abilities. Training progression included Bilateral Max Assist mode, Adaptive mode, and ProStep+ mode, allowing a gradual transition from full robotic assistance to active user-initiated stepping. The intervention provided repetitive, task-specific overground gait practice and progressive engagement in voluntary stepping to promote motor learning, neuromuscular adaptation, and functional gait training in individuals with spinal cord injury.
Locations (1)
IRCCS San Raffaele
Roma, Italy, Italy