About this trial
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
Qualifiers
Age 18 years or older;
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;
Indicated for or using an AFO;
Ability to walk 6-minutes consecutively (with assistive device, if necessary).
Disqualifiers
When wearing the AFO, not able to walk short bouts of 10m without walking aids, such as a walker;
Foot deformities that do not fit in prefab spring-like AFOs;
Weakness of the knee extensor muscles, for which a knee-ankle-foot orthosis is indicated.
Trial design
Treatments tested in this trial
- NEURO SWING AFO (Fior& Gentz, Lüneburg, Germany)
- WalkOn Reaction® (Ottobock, Duderstadt)
- Matrix Max2® (TruLife, Dublin, Ireland)
- Matrix® (TruLife, Dublin, Ireland)
Treatment groups
Sponsors and collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
FIOR & GENTZ
Collaborator