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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke Multiple Sclerosis Cerebral Palsy Neuromuscular Deficits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Condition A

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

Group Type ACTIVE_COMPARATOR

Carbon orthosis (control)

Intervention Type 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

Condition B

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

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No