StrokeNS-BOOSSTNCT07108088
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
A study testing NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation in people with Stroke and Multiple Sclerosis, run by ÖSSUR France at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Multiple Sclerosis, Cerebral Palsy
- What is being tested?
- NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Oct 2025to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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 join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
IMPR du Bois de Lébisey
Hérouville-Saint-Clair, 14200
Anne Lepelletier, +33231463654, a.lepelletier@impr-herouville.com
Anne Lepelletier
- Not yet recruiting
CMPR Bel-Air
La Membrolle-sur-Choisille, 37390
Julien Esnault, +33247424338, julien.esnault@croix-rouge.fr
Julien Esnault
About this study
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
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.
- Conditions
- Stroke, Multiple Sclerosis, Cerebral Palsy, Neuromuscular Deficits
- Being tested
- NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation, Carbon orthosis (control)
- Medical subject headings
- Stroke, Multiple Sclerosis, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulationDevice
The patients will use the experimental device during 14 days straight as well, then a washout period of 7 days with no interventons and then the comparator during 14 days straight. The order in which they will use each device will depend on the groupe they have been randomized in :
- Arm 1 : Control device during 14 days, followed by a 7 day washout period, then exerimental device during 14 days
- Arm 2 : Experimental device during 14 days, followed by a 7 day washout period, then control device during 14 days
Carbon orthosis (control)Device
The patients will use the experimental device during 14 days straight as well, then a washout period of 7 days with no interventons and then the comparator during 14 days straight. The order in which they will use each device will depend on the groupe they have been randomized in :
- Arm 1 : Control device during 14 days, followed by a 7 day washout period, then exerimental device during 14 days
- Arm 2 : Experimental device during 14 days, followed by a 7 day washout period, then control device during 14 days
| Study group | Role | What they receive |
|---|---|---|
| Condition A | Active comparator | Condition A corresponds to the control phase where the patient will use the control device during 14 days. Receives: Device: Carbon orthosis (control) |
| Condition B | Experimental | Condition B corresponds to the experimental phase where the patient will use the experimental device during 14 days. Receives: Device: NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed : 10m walk test
Measured: At all 12 visits from baseline (day 1), to end of study (day 35)
Secondary outcomes (3)
Functional Gait Assessment (FGA)
The Functional Gait Assessment (FGA) is a modification of the Dynamic Gait Index (DGI) that uses higher-level tasks to increase the applicability of the test to people with vestibular disorders and to eliminate the ceiling effect of the original test. Three items were added to the DGI because these were noted to be difficult in people with vestibular disorders.
The FGA is used to assess postural stability during various walking tasks :
- Gait on a Level Surface
- Change in Gait Speed
- Gait with Horizontal Head Turns
- Gait with Vertical Head Turns
- Gait and Pivot Turn
- Step Over Obstacle
- Gait with Narrow Base of Support
- Gait with Eyes Closed
- Ambulating Backwards
- Steps
Measured: At baseline (day 1), day 14, day 22 and end of study (day 35)
6 minute walk test
Measured: At baseline (day 1), day 14, day 22 and end of study (day 35)
Spatio-temoral gait analysis
Measured: At baseline (day 1), day 14, day 22 and end of study (day 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start13 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ÖSSUR France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pôle Saint Hélier
- Responsible party
- Sponsor
- Investigators
- Emilie Leblong, Principal investigator, Fondation Saint Helier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108088
- Sponsor's protocol ID
- 2025-A00585-44
- Acronym
- NS-BOOSST
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No