Evaluation of the NEUROSWING Orthosis on Walking Speed in a Population
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. Clinical Investigation: NS-BOOSST
What it found
No result yet.
What was tested
Treatment tested
- NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation
Compared with
- Carbon orthosis (control)
What it measured
Main measures
Walking speed : 10m walk test
At all 12 visits from baseline (day 1), to end of study (day 35)
Walking and mobility
Other measures (3)
Functional Gait Assessment (FGA)
At baseline (day 1), day 14, day 22 and end of study (day 35)
Walking and mobility6 minute walk test
At baseline (day 1), day 14, day 22 and end of study (day 35)
Walking and mobilitySpatio-temoral gait analysis
At baseline (day 1), day 14, day 22 and end of study (day 35)
Walking and mobility
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* 18 years of age and older * Deficit of the dorsal and/or plantar flexors with at least one of the following components specific to the indication of an AFO: * steppage * foot drop, * spasticity, * failure to transfer weight-bearing, * instability of weight-bearing phase * compensatory hyperextension of the knee * Muscular deficiency of the dorsal and/or plantar flexors principal or accessory * Ambulation possible with or without technical aids * First time using an orthosis used in the study * Being followed in one of the investigating centers whose management and rehabilitation in line with the study's visit schedule. * Having freely consented to participate * Affiliated with a social security scheme
Exclusion criteria
* 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. * Already fitted with a carbon or NEUROSWING orthosis. * Height over 214cm * Weight over 193kg * Pregnant, parturient or breast-feeding women * Person deprived of liberty by a court order (including guardianship, curatorship and safeguard of justice) or administrative order * Person under psychiatric care or admitted to a health or social establishment for purposes other than research * Person in an emergency situation unable to give consent beforehand
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
Oct 2025
Main results due
Dec 2026
Finished
Dec 2026