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

Conditions

• Cerebral Palsy
• Multiple Sclerosis
• Neuromuscular Deficits
• Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

First listed

Aug 6, 2025

Start date

Jul 31, 2025

Status verified

Jul 2025

Primary completion

Sep 15, 2026

Completion

Sep 15, 2026

Study Design

Enrollment

34 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Active Comparator: Condition A
  Condition A corresponds to the control phase where the patient will use the control device during 14 days.
• Experimental: Condition B
  Condition B corresponds to the experimental phase where the patient will use the experimental device during 14 days.

Primary Outcome Measure

Walking speed : 10m walk test [ Time Frame: At all 12 visits from baseline (day 1), to end of study (day 35) ]

Central Contacts

• Emilie Leblong
  +33299295099
  [email protected]

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