NCT07108088Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 8 Jul 2025
- Start date
- 13 Oct 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- ÖSSUR France
- Diseases
- Stroke, Multiple sclerosis
- NCT number
- NCT07108088
What you commit to
- Study type: Interventional
- Planned participants: 34
- From 13 Oct 2025 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive disorders, at the investigator's discretion, impacting the reliability of the clinical tests under study.
- 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.
- Person under psychiatric care or admitted to a health or social establishment for purposes other than research
Other
- Pathology in progressive phase at the time of inclusion that could significantly impact walking (e.g. MS, ALS, etc.) during the entire study period.
- 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 in an emergency situation unable to give consent beforehand
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IMPR du Bois de Lébisey Coordinator of this site? Confirm its status | Hérouville-Saint-Clair | France | Recruiting |
| CMPR Bel-Air Coordinator of this site? Confirm its status | La Membrolle-sur-Choisille | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.