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.
18 years of age and older
steppage
foot drop,
spasticity,
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.
Crossover
NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation
DeviceThe patients will use the experimental device during 14 days straight as well, then a washout period of 7 days with no interventons and then the comparator during 14 days straight. The order in which they will use each device will depend on the groupe they have been randomized in : * Arm 1 : Control device during 14 days, followed by a 7 day washout period, then exerimental device during 14 days * Arm 2 : Experimental device during 14 days, followed by a 7 day washout period, then control device during 14 days
Carbon orthosis (control)
DeviceThe patients will use the experimental device during 14 days straight as well, then a washout period of 7 days with no interventons and then the comparator during 14 days straight. The order in which they will use each device will depend on the groupe they have been randomized in : * Arm 1 : Control device during 14 days, followed by a 7 day washout period, then exerimental device during 14 days * Arm 2 : Experimental device during 14 days, followed by a 7 day washout period, then control device during 14 days
Walking speed : 10m walk test
Functional Gait Assessment (FGA)
The Functional Gait Assessment (FGA) is a modification of the Dynamic Gait Index (DGI) that uses higher-level tasks to increase the applicability of the test to people with vestibular disorders and to eliminate the ceiling effect of the original test. Three items were added to the DGI because these were noted to be difficult in people with vestibular disorders. The FGA is used to assess postural stability during various walking tasks : * Gait on a Level Surface * Change in Gait Speed * Gait with Horizontal Head Turns * Gait with Vertical Head Turns * Gait and Pivot Turn * Step Over Obstacle * Gait with Narrow Base of Support * Gait with Eyes Closed * Ambulating Backwards * Steps
6 minute walk test
Spatio-temoral gait analysis
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ÖSSUR France
Lead sponsor
Pôle Saint Hélier
Collaborator
