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Bidirectional Tuning of the AFO Stiffness

RecruitingNAAges 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Ams…
NCT06412055 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this pilot study with a pre-post design is to investigate the effects of separate individualization of the AFO stiffness towards plantar- and dorsiflexion in a spring-hinged AFO on walking compared to a spring-like AFO (3 types) having the same stiffness in both directions. People with a neuromuscular disease or nerve injury causing at least plantarflexor weakness (determined as the inability to perform 3 single heel rises), with an indication for or using an AFO, will be fitted with a new, custom-made spring-hinged AFO with the NEURO SWING® system ankle joint (Fior\& Gentz, Lüneburg, Germany), of which the stiffness of ventral and dorsal compartment of this spring-hinged AFO will be individualized. For comparison, measurements will be performed with three different prefab spring-like AFOs with different stiffness levels (but which have a similar stiffness towards plantar an

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📋 Eligibility rules (as published)
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.
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What it tests

  • NEURO SWING AFO (Fior& Gentz, Lüneburg, Germany)
  • WalkOn Reaction® (Ottobock, Duderstadt)
  • Matrix Max2® (TruLife, Dublin, Ireland)
  • Matrix® (TruLife, Dublin, Ireland)
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Where

1 site
Department of rehabilitation medicine Amsterdam UMC, location AMC
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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