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

Study acronym: NS-BOOSST
StatusRecruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 15, 2026 → Dec 31, 2026
See other at-risk trials from ÖSSUR France

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Recruitment opened Show 5 more changesShow less
    • Primary and study completion pushed from Sep 15, 2026 to Dec 31, 2026
    • Start date changed from estimate of Jul 31, 2025 to Oct 13, 2025
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised at 2 of 2 sites
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
3,544 trials monitored
See 167 trials at risk
1,018 trials monitored
See 37 trials at risk
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.
Trial Details
NCT Number NCT07108088
Lead Sponsor ÖSSUR France
Collaborators: Pôle Saint Hélier
Conditions
(from sponsor)
Stroke, Multiple Sclerosis, Cerebral Palsy, Neuromuscular Deficits
Related terms Cerebral Palsy, Multiple Sclerosis, Stroke
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov