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

NCT07108088 | Not Yet Recruiting

• 1 other identifier: 2025-A00585-44
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Walking speed : 10m walk test

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

Secondary Outcomes (3)

• Functional Gait Assessment (FGA)

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

• 6 minute walk test

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

• Spatio-temoral gait analysis

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

Study Arms (2)

Condition A

ACTIVE COMPARATOR

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

Device: Carbon orthosis (control)

Condition B

EXPERIMENTAL

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

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

Condition B

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

Condition A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive disorders, at the investigator's discretion, impacting the reliability of the clinical tests under study.
• 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

Sponsors & Collaborators

• ÖSSUR France: lead
• Pôle Saint Hélier: collaborator

Study Sites (2)

IMPR du Bois de Lébisey

Hérouville-Saint-Clair, 14200, France

Location

CMPR Bel-Air

La Membrolle-sur-Choisille, 37390, France

Location

MeSH Terms

Conditions

Stroke; Multiple Sclerosis; Cerebral Palsy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Brain Damage, Chronic

Study Officials

• Emilie Leblong

  Fondation Saint Helier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Leblong

CONTACT

+33299295099; emilie.leblong@fondationsainthelier.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 6, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

FR (2)