Tests an active ankle brace on walking speed in people with weak ankle muscles
Tests an active ankle brace against a carbon brace in adults with weak ankle muscles.
Key facts
- Who runs it
- ÖSSUR France
- Where
- Hérouville-Saint-Clair and La Membrolle-sur-Choisille, FranceSee the 2 sites
- Trial code
- Registry title
- 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
- Status
- Recruiting
- People taking part
- 34 people, planned
- Started
- 13 Oct 2025
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation
- Carbon orthosis (control)
- Record updated
- 14 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with weak ankle and foot lift or push-off muscles who can walk and need a leg brace. It compares the NEUROSWING brace with a carbon brace.
- Age
- 18 years and older
- Sex
- All sexes can join
- Disease stage
- Weakness of the muscles that lift or push down the foot, with at least one sign such as steppage, foot drop, spasticity or instability when standing on the leg. The person must be able to walk, with or without walking aids.
- Earlier treatment
- Must be using this type of brace for the first time. Cannot already have a carbon or NEUROSWING brace.
Main reasons for not taking part
- Thinking problems that make the walking tests unreliable
- A disease in an active phase that could strongly affect walking, such as MS or ALS
- Medically unstable, for example severe heart problems
- Behaviour problems such as agitation or dementia that could affect walking
- Pregnant, giving birth or breast-feeding women
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
Where in France
- IMPR du Bois de LébiseyHérouville-Saint-Clair, FranceContact: Anne LepelletierTaking people
- CMPR Bel-AirLa Membrolle-sur-Choisille, FranceContact: Julien EsnaultNot yet recruiting
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Condition AExisting treatment, for comparison
Condition A corresponds to the control phase where the patient will use the control device during 14 days.
Treatment: Carbon orthosis (control)
- Condition BTreatment being tested
Condition B corresponds to the experimental phase where the patient will use the experimental device during 14 days.
Treatment: NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests an active ankle brace on walking speed in people with weak ankle musclesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 14 October 2026