Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06412055

Bidirectional Tuning of the AFO Stiffness

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-02-05

10

Participants Needed

1

Research Sites

37 weeks

Total Duration

On this page

Sponsors

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead Sponsor

F

FIOR & GENTZ

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Bidirectional Tuning of the AFO Stiffness

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Plantar flexor weakness in at least one leg, shown by a muscle testing score below 5 or inability to perform three single heel rises, with or without dorsiflexion weakness
  • Indicated for or currently using an ankle-foot orthosis (AFO)
  • Ability to walk continuously for 6 minutes, with or without an assistive device
Not Eligible

You will not qualify if you...

  • Unable to walk short distances of 10 meters without walking aids like a walker while wearing an AFO
  • Foot deformities that prevent fitting into prefab spring-like AFOs
  • Knee extensor muscle weakness requiring a knee-ankle-foot orthosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of rehabilitation medicine Amsterdam UMC, location AMC

Amsterdam, Netherlands, 1105AZ

Actively Recruiting

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Research Team

M

Merel-Anne Brehm, PhD

CONTACT

E

Elza van Duijnhoven

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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