RecruitingNot ApplicableNCT06412055

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


Sponsor

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

Enrollment

10 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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).

Exclusion Criteria3

  • 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.

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Interventions

DEVICENEURO SWING AFO (Fior& Gentz, Lüneburg, Germany)

stiffness-optimized custom-made spring-hinged AFO with the NEURO SWING® system ankle joint build in

DEVICEWalkOn Reaction® (Ottobock, Duderstadt)

comparator: prefab spring-like AFO without hinge with a predefined stiffness (2.8 Nm/degree).

DEVICEMatrix Max2® (TruLife, Dublin, Ireland)

comparator: prefab spring-like AFO without hinge with a predefined stiffness (1.4 Nm/degree)

DEVICEMatrix® (TruLife, Dublin, Ireland)

comparator: prefab spring-like AFO without hinge with a predefined stiffness (0.6 Nm/degree)


Locations(1)

Department of rehabilitation medicine Amsterdam UMC, location AMC

Amsterdam, Netherlands

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NCT06412055


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