About this trial
The aim of this randomized, cross-over, multi-center, intention-to-treat, open-label study study is to determine the benefits of the NEUROSWING device on gait speed in patients with dorsal and/or plantar flexor deficits, compared with the use of a carbon orthosis. Each patient will benefit in random order from a 14-day investigation period with the NEUROSWING device and a 14-day control period with a carbon orthosis. These two 2-week periods will be separated by one week, during which no orthosis will be worn and no evaluation will be carried out. Patients will be randomized to determine which phase they will start with. The primary endpoint is walking speed, which will be measured by comparing the results of the 10-meter walk test. For the secondary endpoints, patients will be assessed using the Functional Gait Assessment (FGA), the 6-minute test and an analysis system that will analyze other gait parameters (duration of the different phases of the gait cycle, cadence and step length). In order to carry out the assessments, each patient included will have 12 visits spread over 5 weeks.
Eligibility criteria
Qualifiers
18 years of age and older
steppage
foot drop,
spasticity,
Disqualifiers
Cognitive disorders, at the investigator's discretion, impacting the reliability of the clinical tests under study.
Pathology in progressive phase at the time of inclusion that could significantly impact walking (e.g. MS, ALS, etc.) during the entire study period.
Medically unstable (e.g. severe cardiovascular disorders) as judged by the investigating physician.
Behavioral disorders (opposition, agitation, dementia) which, according to the investigator's judgment, would have an impact on walking.
Trial design
Treatments tested in this trial
- NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation
- Carbon orthosis (control)
Treatment groups
Sponsors and collaborators
ÖSSUR France
Lead sponsor
Pôle Saint Hélier
Collaborator