Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07108088

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Stroke Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Damage, Chronic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy Cerebrovascular Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Neuromuscular Deficits Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IMPR du Bois de Lébisey, Hérouville-Saint-Clair, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

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)

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

    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

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie Leblong

CONTACT

[email protected]

+33299295099

Sponsors and collaborators

Lead sponsor

ÖSSUR France

Industry

Collaborators

  • Pôle Saint Hélier

Registry information

Official study 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

Acronym: NS-BOOSST

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.