ClinicalTrials.gg
RecruitingNCT07108088NS-BOOSSTUpdated Oct 14, 2026

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

An interventional study of NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation and Carbon orthosis (control) in Stroke, Multiple Sclerosis and Cerebral Palsy, sponsored by ÖSSUR France. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by ÖSSUR France (part of Embla Medical hf.) · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.
Updated Oct 14, 2026Now RecruitingSite recruiting status changed+3 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 543 studies in Stroke with a site in France — 141 open to participants now, 160 under way, 12 of them phase 3. Stroke · France.

Planned enrollment
252nd of 368
34 · median 65
Started
2025
with 38 others
No phase
275 of 543
92 open now
Primary completion
2026-12
later than 54 of 159 live
Registered
503rd of 543
by date

Among the 543 studies in Stroke with a site in France, this one is the 252nd largest by planned enrollment of the 368 interventional ones that give a count, is one of 39 that started in 2025, is one of 275 with no phase, reaches primary completion later than 54 of the 159 other live ones, and was the 503rd registered.

Stroke

8,258 studies on the registry are indexed under Stroke; 2,062 are open to participants now.

Browse Stroke studies →

Open to participants now

141 of the 543 studies in Stroke with a site in France are open now. Recruiting first, the newest first:

135 more — sign in →

All 141 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 1,418 Stroke studies recruiting now, 696 (49%) set no upper age limit and 282 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Stroke
  • Multiple Sclerosis
  • Cerebral Palsy
  • Neuromuscular Deficits
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Active comparator
    Condition A

    Condition A corresponds to the control phase where the patient will use the control device during 14 days.

    Device: Carbon orthosis (control)

  • Experimental
    Condition B

    Condition B corresponds to the experimental phase where the patient will use the experimental device during 14 days.

    Device: NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation

Interventions

  • DeviceNEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation

    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

  • DeviceCarbon orthosis (control)

    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

06

What researchers measure

Primary outcomes

  1. Walking speed : 10m walk test

    Time frame: At all 12 visits from baseline (day 1), to end of study (day 35)

Secondary outcomes

  1. 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

    Time frame: At baseline (day 1), day 14, day 22 and end of study (day 35)

  2. 6 minute walk test

    Time frame: At baseline (day 1), day 14, day 22 and end of study (day 35)

  3. Spatio-temoral gait analysis

    Time frame: At baseline (day 1), day 14, day 22 and end of study (day 35)

07

Study locations

1 of 2 sites recruiting
  • IMPR du Bois de Lébisey
    Hérouville-Saint-Clair, 14200, France
    Recruiting
  • CMPR Bel-Air
    La Membrolle-sur-Choisille, 37390, France
    Not yet recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Dec 2026, 14 months after the start.

Of 144 industry-sponsored interventional studies with no phase under Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 14 months is below that.

Counting every sponsor, half of 3,261 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 14, 2026: start Jul 2025 → Oct 2025, primary completion Sep 2026 → Dec 2026 and completion Sep 2026 → Dec 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2025
First posted
Aug 6, 2025
StartActual
Oct 13, 2025was Jul 2025
Primary completionEst.
Dec 31, 2026was Sep 2026
CompletionEst.
Dec 31, 2026was Sep 2026
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 14, 2026
Sites
2 sites changed recruiting status (1 now recruiting, 1 now not yet recruiting)
Show 2 sites
  • IMPR du Bois de Lébisey · Hérouville-Saint-Clair, Franceno status→Recruiting
  • CMPR Bel-Air · La Membrolle-sur-Choisille, Franceno status→Not yet recruiting
Oct 14, 2026
Start date
Jul 31, 2025→Oct 13, 2025 (actual)
Oct 14, 2026
Primary completion
Sep 15, 2026→Dec 31, 2026
Oct 14, 2026
Study completion
Sep 15, 2026→Dec 31, 2026
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    Not yet recruiting→Recruiting
    2 sites changed recruiting status (1 now recruiting, 1 now not yet recruiting)
    Show 2 sites
    • IMPR du Bois de Lébisey · Hérouville-Saint-Clair, Franceno status→Recruiting
    • CMPR Bel-Air · La Membrolle-sur-Choisille, Franceno status→Not yet recruiting
    Start date Jul 31, 2025→Oct 13, 2025 (now actual)
    Primary completion Sep 15, 2026→Dec 31, 2026
    Study completion Sep 15, 2026→Dec 31, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07108088
Lead sponsor
ÖSSUR France
Collaborators
Pôle Saint Hélier
Responsible party
Sponsor
First posted
Aug 6, 2025
Start date
Oct 13, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 14, 2026

Study contacts

Emilie Leblong
Contact
emilie.leblong@fondationsainthelier.com
+33299295099
Emilie Leblong
principal investigator · Fondation Saint Helier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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