Can a powered ankle brace help people with foot drop walk faster

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, cross-over, multi-center study compares two 14-day periods of wearing the NEUROSWING orthosis versus a carbon orthosis, with a one-week washout in between. Participants with dorsal and/or plantar flexor deficits related to stroke, MS, CP, or neuromuscular issues will be assessed using the 10-meter walk test and secondary gait measures. The trial uses intention-to-treat analysis and open-label design, with walking speed as the primary endpoint and additional gait assessments as secondary endpoints.

Why it matters

Who can join: the full rules

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

Where it's running

• IMPR du Bois de Lébisey
  Hérouville-Saint-Clair, France Recruiting
• CMPR Bel-Air
  La Membrolle-sur-Choisille, France Not yet recruiting

Study contacts

• Principal investigator: Emilie Leblong — Fondation Saint Helier
• Study coordinator: Emilie Leblong
• Email: emilie.leblong@fondationsainthelier.com
• Phone: +33299295099

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.