Clinical Research Directory

Powered Exoskeleton-Assisted Walking in Persons With Spinal Cord Injury

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.

Efficacy of Intensive Visual Simulation (IVS) Before Exoskeleton-assisted Step Training in Patients With Hemisensory Syndrome With Brain Injury of Vascular Etiology.

Clinical trial involving a medical device, not intended for CE marking, randomized, blinded to evaluate the efficacy of preparatory treatment with Intensive Visual Simulation 4 (IVS) prior to exoskeleton-assisted (EKSO) step training in achieving independent ambulation in hemiparetic patients with impaired proprioceptive sensation. Patients will be randomized into two groups: one group in which patients will undergo IVS treatment before physiotherapy and robotic step training with an exoskeleton; and one group in which patients will undergo only physiotherapy and robotic step training with an exoskeleton.

Exploring the Effect of the Hypershell Hip Exoskeleton on Fatiguing, Everyday Activities in Older Adults

The goal of this clinical trial is to learn how wearing the Hypershell lower-limb exoskeleton affects perceived fatigue during everyday mobility activities in adults aged 65 years and older. The main questions it aims to answer are: * Does active assistance from the Hypershell reduce the development of perceived fatigue during repeated everyday mobility tasks? * Does wearing the Hypershell affect how long participants can perform the protocol and how many tasks they can complete before reaching a high level of fatigue? * How do participants perceive the usability, comfort, and overall experience of using the Hypershell? * What are the biomechanical and physiological responses from wearing the Hypershell? Researchers will compare two conditions: performing the mobility protocol without the Hypershell and wearing the Hypershell with active assistance. Participants will: * Attend one baseline session including questionnaires, physical tests, and familiarization with the Hypershell and study procedures. * Attend two experimental sessions in a randomized order, with at least one week between sessions. * Complete a laboratory-based mobility protocol including daily activities such as standing up from a chair, walking, stair climbing, slope walking, walking on uneven surfaces, carrying an object, and performing a cognitive task while walking. * Report their perceived fatigue throughout the protocol using the Borg CR10 scale. * Wear non-invasive sensors that measure physiological responses and movement during the experimental sessions. * Provide feedback about their experience using the HyperShell.

Effects of Mobilization Using a Powered Lower-limb Exoskeleton With Prolonged Mechanical Ventilation

This study aims to evaluate the effects of powered lower-limb exoskeleton-assisted training on lower limb strength, respiratory parameters, 28-day ventilator-free days, and length of hospital stay in patients with prolonged mechanical ventilation admitted to a Respiratory Care Center. The goal is to provide clinical evidence for integrating rehabilitation and respiratory care in this patient population.

Evaluation of Trunk Assistance Exoskeleton

The goal of this interventional study is to evaluate the effect of three different designs of trunk assistance exoskeletons on cumulative lumbar load, trunk extensors' muscular fatigue and comfort in healthy volunteers. The main questions it aims to answer is: will exoskeletons reduce muscle fatigue and cumulative lumbar load. Participants will : * get each exoskeletons adjusted and then practice the lifting task and measurement sequence in a first session * perform a lifting task for 4 blocks of 20 minutes on different sessions for each exoskeleton, another session is performed without assistance.

A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation

Systematic and professional rehabilitation training is generally effective for patients with lower limb dyskinesia, but most of them lose the chance of recovery due to failure to receive systematic rehabilitation treatment. Our team has developed an intelligent power armor for patients with lower limb motor dysfunction, which can assist patients to complete high-quality rehabilitation training. In order to evaluate the safety and efficacy of the Smart Power Armor for post-surgical spine patients, and to provide data support for a confirmatory clinical study, we designed a single-center, prospective, randomized controlled study to compare the level of recovery of lower limb motor function in patients with different rehabilitation strategies.

Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking

The primary objective of this clinical follow-up is to analyze data regarding the safety of the UNILEXA passive exoskeleton post-market. The secondary objective is to assess the effectiveness of the device in improving activities of daily living (ADL) through improved mobility, endurance and health-related quality of life (QoL). The aim of this study is to provide real-world evidence to support wider clinical and home use of the exoskeleton. This observational study is designed for 6 participants from a population of individuals with lower limb paralysis. The study will have a duration of 14 weeks. During this period, participants will visit Janske Lazne three times for routine measurements in a biomechanical laboratory, which will be integrated into their usual physiotherapy sessions.