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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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 devic
• Устройство 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 devic

Первичные конечные точки

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

Вторичные конечные точки (3)

• Functional Gait Assessment (FGA) [Срок оценки: At baseline (day 1), day 14, day 22 and end of study (day 35)]
• 6 minute walk test [Срок оценки: At baseline (day 1), day 14, day 22 and end of study (day 35)]
• Spatio-temoral gait analysis [Срок оценки: At baseline (day 1), day 14, day 22 and end of study (day 35)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 2 центра

• IMPR du Bois de Lébisey — Hérouville-Saint-Clair
• CMPR Bel-Air — La Membrolle-sur-Choisille

Идентификаторы

NCT: NCT07108088 · 2025-A00585-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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