An observational study in Spinal Cord Injuries (SCI), Muscle Spasticity as a Result of Spinal Cord Injury and Rehabilitation, sponsored by IRCCS San Raffaele Roma. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by IRCCS San Raffaele Roma · Observational
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.
Spinal cord injury (SCI) is a debilitating neurological condition associated with severe motor and sensory impairments that frequently result in reduced mobility, limitations in activities of daily living, and diminished quality of life. Among the most common secondary complications of SCI is spasticity, a motor disorder characterized by increased muscle tone and exaggerated tendon reflexes that can negatively affect mobility, comfort, functional independence, and participation in everyday activities. Current rehabilitation approaches aim not only to improve walking ability but also to address secondary complications such as spasticity and reduced functional autonomy.
Recent advances in rehabilitation robotics have introduced wearable powered exoskeletons as an innovative therapeutic tool for gait rehabilitation in individuals with SCI. Unlike stationary robotic gait devices, wearable overground exoskeletons allow individuals to practice walking in real-world environments while actively participating in movement generation. These systems facilitate repetitive, task-specific, and intensive gait training, providing proprioceptive and sensory feedback that may promote neuroplasticity, motor learning, and neuromuscular re-education. Emerging evidence suggests that exoskeleton-assisted gait training may positively influence both motor and non-motor outcomes, including reductions in spasticity, improvements in functional independence, and enhanced participation in rehabilitation programs.
Although previous studies have reported beneficial effects of robotic gait training in SCI populations, limited evidence is available regarding the relationship between treatment dosage and rehabilitation outcomes, particularly with respect to spasticity management. Understanding whether the number of exoskeleton-assisted training sessions influences clinical outcomes may provide valuable information for optimizing rehabilitation protocols and supporting evidence-based implementation of robotic technologies in routine clinical practice.
The present multicenter study was designed to evaluate the effects of wearable powered overground exoskeleton-assisted gait training on spasticity and functional independence in individuals with SCI. The study also aimed to investigate whether treatment dosage, defined as the total number of completed exoskeleton-assisted gait training sessions, was associated with differential rehabilitation outcomes.
This investigation was conducted across four specialized neurorehabilitation centers in Italy: IRCCS San Raffaele Roma, San Raffaele Sulmona, IRCCS Centro Neurolesi Bonino Pulejo Messina, and Montecatone Rehabilitation Institute. The study included adult individuals with traumatic or non-traumatic SCI who participated in a structured exoskeleton-assisted gait rehabilitation program using the EksoGT™ wearable powered exoskeleton (Ekso Bionics, Richmond, California, USA).
Participants were eligible if they were between 18 and 70 years of age, had a confirmed diagnosis of SCI, and were able to maintain an upright standing posture with sufficient cardiovascular stability to participate safely in gait training. Individuals were required to complete a minimum of five exoskeleton-assisted gait training sessions with a frequency of at least two sessions per week. Participants with severe cognitive impairment, neurological comorbidities, contraindications to exoskeleton use, recent botulinum toxin treatment, or severe medical conditions preventing safe participation were excluded.
The exoskeleton intervention was integrated into each participant's individualized multidisciplinary rehabilitation program. In addition to robotic gait training, participants continued to receive conventional rehabilitation interventions according to local clinical practice, including physiotherapy, occupational therapy, and other therapeutic activities deemed appropriate by the rehabilitation team. Throughout the study period, pharmacological management remained unchanged whenever possible to minimize confounding influences on outcome measures.
Exoskeleton-assisted gait training was delivered using the EksoGT™ wearable powered exoskeleton. Sessions were conducted under therapist supervision and generally lasted approximately 60 minutes. During training, the device was individually adjusted according to participant anthropometric characteristics and functional abilities. Rehabilitation progression followed a structured approach, beginning with high levels of robotic assistance and gradually transitioning toward more active participation. Initial sessions were typically performed using Bilateral Max Assist mode, in which the exoskeleton provided full assistance for hip and knee movements throughout the gait cycle. As participants improved, assistance levels were progressively reduced through Adaptive and ProStep+ modes, requiring increasing levels of voluntary initiation and motor engagement.
The primary outcome of interest was lower-limb spasticity. Spasticity was assessed using the Modified Ashworth Scale (MAS), with evaluations performed bilaterally at the hip, knee, and ankle flexor and extensor muscle groups. Aggregated scores were calculated to provide both segment-specific and overall measures of spasticity severity. This approach allowed the investigation of potential differential effects across proximal, intermediate, and distal lower-limb segments.
Functional independence was evaluated using the Spinal Cord Independence Measure (SCIM) version III. The SCIM III is a validated instrument specifically designed for individuals with SCI and assesses performance in activities of daily living, mobility, respiration, and sphincter management. Total SCIM III scores were used as an indicator of functional autonomy and participation.
Additional demographic and clinical variables were collected, including age, sex, etiology of SCI (traumatic or non-traumatic), neurological impairment according to the American Spinal Injury Association (ASIA) Impairment Scale, neurological level of injury, time since injury, and treatment dosage expressed as the total number of exoskeleton-assisted training sessions completed. Adverse events related to exoskeleton use were also documented.
Outcome assessments were performed before initiation of the exoskeleton training program and after completion of the intervention period. Changes in spasticity and functional independence were analyzed to determine the clinical effects of exoskeleton-assisted gait training. Secondary analyses explored the potential influence of treatment dosage and participant characteristics, including lesion level, injury chronicity, and etiology, on rehabilitation outcomes.
The study was conducted in accordance with the principles of the Declaration of Helsinki and received approval from the competent ethics committee. All participants provided written informed consent for the collection and use of their clinical data for research purposes.
The findings of this study are expected to contribute to the growing body of evidence supporting the use of wearable powered exoskeletons in SCI rehabilitation and to provide clinically relevant information regarding the optimal intensity and dosage of robotic gait training interventions for reducing spasticity and improving functional independence.
1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.
This study's enrollment of 74 is above the median of 60 across 332 observational studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →IRCCS San Raffaele Roma is the lead sponsor of 68 studies on the registry; 27 are open to participants now.
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Eligible participants were adults aged 18-70 years with a confirmed diagnosis of SCI and the ability to maintain an upright posture for at least one minute with sufficient cardiovascular stability, including those able 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 (i.e., not fully dependent on manual support). Participants included both inpatients undergoing intensive rehabilitation and outpatients attending scheduled gait training sessions. Inclusion criteria required also a minimum of five training sessions using a wearable-powered exoskeleton, with a frequency of two or more sessions per week.
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Exclusion Criteria:
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.
Device: 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.
Modified Ashworth Scale (MAS)
Change in lower limb spasticity measured using the aggregated Modified Ashworth Scale (MAS). Spasticity was assessed bilaterally at the hip, knee, and ankle flexor and extensor muscle groups, and aggregated scores were calculated to provide an overall measure of lower-limb spasticity. Higher scores indicate greater spasticity.
Time frame: Baseline (day 1) and at the end of the 15th gait training sesssion (after 5 weeks from the day 1).
Spinal Cord Independece Measure (SCIM) version III
The SCIM assesses traumatic and non-traumatic, acute and chronic activities of daily living (coordination, eating, functional mobility, incontinence) of persons with a spinal cord injury. The SCIM III is composed of 19 items that assess 3 domains (Self-care; Respiration and Sphincter Management; Mobility), and the total scores range from 0 (lower participation in ADL) to 100 (higher participation in ADL).
Time frame: Baseline (day 1) and at the end of the 15th gait training sesssion (after 5 weeks from the day 1).
American Spinal Injury Association (ASIA) Impairment Scale
The American Spinal Injury Association (ASIA) Impairment Scale is a standardized neurological classification system used to assess the severity of spinal cord injury. The scale classifies individuals into five categories, from A (complete injury with no sensory or motor function preserved in the sacral segments S4-S5) to E (normal sensory and motor function). Higher grades indicate greater preservation of neurological function.
Time frame: Baseline (day 1)
Plan to share: Undecided — The investigators have not yet determined whether individual participant data will be shared. Any future data-sharing plan will be considered in accordance with participant confidentiality requirements, institutional policies, ethical approvals, and applicable regulations.
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Ran from Sep 2024 to primary completion in May 2025, 8 months.
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IRCCS San Raffaele Roma