NCT06412055 Bidirectional Tuning of the AFO Stiffness
| NCT ID | NCT06412055 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Neuromuscular Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2025-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-05-15 with a primary completion date of 2025-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 and dorsiflexion), and the participants' current AFO if applicable, and shoes-only at baseline. The main outcome parameters will be the maximal ankle plantarflexion angle, ankle angular velocity and knee flexion angle during the loading response, which will be measured using a 3D gait analysis. Secondary outcomes include other gait biomechanics, walking energy cost, walking speed, standing balance, perceived physical functioning and perceived walking ability.
Eligibility 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.
Contact & Investigator
Frans Nollet, MD PhD
STUDY DIRECTOR
Amsterdam UMC, location AMC
Frequently Asked Questions
Who can join the NCT06412055 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuromuscular Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06412055 currently recruiting?
Yes, NCT06412055 is actively recruiting participants. Contact the research team at m.a.brehm@amsterdamumc.nl for enrollment information.
Where is the NCT06412055 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06412055 clinical trial?
NCT06412055 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Frans Nollet, MD PhD at Amsterdam UMC, location AMC. The trial plans to enroll 10 participants.