Powered Exoskeleton-Assisted Walking in Persons With Spinal Cord Injury
Key facts
- Who runs it
- IRCCS San Raffaele Roma
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 74 people enrolled
- Started
- 1 Sept 2024
- Ended
- 15 May 2026
- Type of study
- Observational
- Treatments tested
- Wearable Powered Exoskeleton
- Record updated
- 20 October 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- adults aged 18-70 years with a confirmed diagnosis of SCI
- ability to maintain an upright posture for at least one minute
- sufficient cardiovascular stability
- ability to stand with double or single support, with or without supervision, or with a minimum-to-moderate level of therapist assistance, based on clinical judgment
- inpatient or outpatient
- clinically stable and with the pharmacological therapy unchanged throughout the observation period
Who cannot take part
- botulinum toxin in the previous 3 months and during the observation phase
- neurological comorbidities
- contraindications to exoskeleton use
- cognitive deficits impairing comprehension or participation
- severe comorbidities with relevance to cardiovascular function
- physical limitations that prevented exoskeleton fitting
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Exoskeleton-Assisted Gait Training
Individuals with spinal cord injury who underwent gait rehabilitation using the EksoGT wearable powered overground exoskeleton as part of their rehabilitation program. Outcomes were assessed before and after completion of training.
Treatment: Wearable Powered Exoskeleton
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Multicenter Retrospective Observational Study on Gait Training With a Powered Overground Exoskeleton in Persons With Spinal Cord Injury
- Record updated
- 20 October 2026