Bidirectional Tuning of the AFO Stiffness - Trial NCT06412055
Access comprehensive clinical trial information for NCT06412055 through Pure Global AI's free database. This phase not specified trial is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) and is currently Not yet recruiting. The study focuses on Neuromuscular Disorders. Target enrollment is 10 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
NEURO SWING AFO (Fior& Gentz, Lüneburg In Duderstadt, Germany)
Interventional
device
Sponsor & Location
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Timeline & Enrollment
N/A
May 05, 2024
Feb 01, 2025
Primary Outcome
maximal ankle angular velocity in loading response in degrees
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 In Duderstadt, 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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06412055
Device Trial