Customizing AFO stiffness for better walking in neuromuscular disorders
Official title: Optimizing Gait with Bidirectional Tuning of the Ankle-foot Orthosis (AFO) Stiffness in People with Lower Leg Muscle Weakness
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06412055 · Data updated 2026-11-12
This study is testing if a custom-made ankle-foot brace with adjustable stiffness can help people with neuromuscular disorders walk better and feel safer compared to standard braces.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Status | Recruiting |
| Started | May 15, 2024 |
| Main results expected | February 1, 2025 |
| Study ends | February 1, 2025 |
| Registry record updated | February 5, 2025 |
| Trial ID | NCT06412055 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with plantar flexor weakness and an indication for or current use of an AFO.
✕Probably not a fit
Patients who cannot walk short distances without assistance or have knee extensor weakness may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study aims to evaluate the effects of individually tuning the stiffness of a spring-hinged ankle-foot orthosis (AFO) for both plantarflexion and dorsiflexion in patients with neuromuscular disorders. Participants will be fitted with a custom-made NEURO SWING® AFO and compared against three types of standard spring-like AFOs that have uniform stiffness in both directions. The study will assess gait biomechanics, walking energy cost, speed, and balance, as well as perceived physical functioning after six weeks of using the new AFO. The goal is to determine if individualized stiffness can improve walking ability and safety for these patients.
Why it matters
Potential benefit: If successful, this approach could significantly enhance walking ability and safety for patients with neuromuscular disorders.
How similar studies have gone: While the concept of customizing AFO stiffness is promising, this specific approach of bidirectional tuning is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older; 2. Presence of plantar flexor weakness in at least one leg, determined as a score lower than 5 on the manual muscle testing scale (Medical Research Council- MRC) and/or inability to perform three single heel rises, with or without dorsiflexion weakness; 3. Indicated for or using an AFO; 4. Ability to walk 6-minutes consecutively (with assistive device, if necessary). Exclusion Criteria: 1. When wearing the AFO, not able to walk short bouts of 10m without walking aids, such as a walker; 2. Foot deformities that do not fit in prefab spring-like AFOs; 3. Weakness of the knee extensor muscles, for which a knee-ankle-foot orthosis is indicated.
Where it's running
-
Department of rehabilitation medicine Amsterdam UMC, location AMC
Amsterdam, Netherlands Recruiting
Study contacts
- Study coordinator: Merel-Anne Brehm, PhD
- Email: m.a.brehm@amsterdamumc.nl
- Phone: + 3120 5664049
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.