NCT06412055

Bidirectional Tuning of the AFO Stiffness

Optimizing Gait With Bidirectional Tuning of the Ankle-foot Orthosis (AFO) Stiffness in People With Lower Leg Muscle Weakness
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Neuromuscular Disorders
Drug/Device/Intervention
NEURO SWING AFO (Fior& Gentz, Lüneburg In Duderstadt, Germany)
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Location
Amsterdam, Netherlands
Timeline & enrollment
Phase
N/A
Start date
May 05, 2024
End date
Feb 01, 2025
Enrollment
10 participants
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
Other disorders of muscleDisorders of musclesOther specified disorders of musclePrimary disorders of musclesOther primary disorders of muscles
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06412055
Type
Device Trial
About this record

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.