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

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.

Conditions

• Stroke
• Multiple Sclerosis
• Cerebral Palsy
• Neuromuscular Deficits

Interventions

DEVICE

NEUROSWING 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

DEVICE

Carbon 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

Sponsors & Collaborators

• Pôle Saint Hélier

  collaborator OTHER

• ÖSSUR France

  lead INDUSTRY

Principal Investigators

• Emilie Leblong · Fondation Saint Helier

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-31

Primary Completion

2026-09-15

Completion

2026-09-15

Countries

• France

Study Locations