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

Launched by ÖSSUR FRANCE · Jul 31, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new device called the NEUROSWING orthosis helps people walk faster. It focuses on individuals who have difficulty moving their foot and ankle muscles, which can happen after conditions like stroke, multiple sclerosis, cerebral palsy, or other nerve and muscle problems. The study compares walking speed when using the NEUROSWING device versus a traditional carbon orthosis (a type of supportive brace). Each person will try both devices for two weeks each, with a one-week break in between, and their walking will be tested through simple walking exercises.

People aged 18 and older who have trouble lifting or lowering their foot due to muscle weakness or stiffness, and who can walk with or without help, may be eligible to join. Participants should not have used either of these braces before and need to be able to attend all study visits over about five weeks. During the study, participants will have 12 visits where their walking speed, balance, and other walking details will be carefully measured. This trial is not yet recruiting, but it hopes to better understand how the NEUROSWING device might improve walking, which could help make it more widely available and covered by insurance in the future.

Gender

ALL

Eligibility criteria

• 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