Evaluation of the NEUROSWING Orthosis on Walking Speed in a Population With Dorsal and/or Plantar Flexor Deficits, With a View to a Reimbursement Application

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorÖSSUR France

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

34 Participants
are divided into 2 treatment groups

Sponsors and collaborators

ÖSSUR France

Lead sponsor

Pôle Saint Hélier

Collaborator