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Optimizing gait with bidirectional tuning of the ankle-foot orthosis (AFO) stiffness in people with lower leg muscle weakness

Optimizing gait with bidirectional tuning of the ankle-foot orthosis (AFO) stiffness in people with lower leg muscle weakness* - Bidirectional tuning of the AFO stiffness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56679
Enrollment
10
Registered
2023-11-30
Start date
2024-05-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

flaccid paresis

Interventions

Participants will be fitted with a new, custom-made spring-hinged AFO with the NEURO SWING® system ankle joint (Fior&amp
Gentz). The stiffness of the ventral and dorsal compartment of this spring-hinged AFO will be individualized using a previously developed optimization algorithm. The spring-hinged AFO with optimal&nbs
stiffness settings will be used at home for 6-weeks. For comparison, we will test the effect of three different prefab spring-like AFOs without hinge with different stiffness levels (but which have a

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •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;  •Able to walk 6-minutes consecutively (with assistive device, if necessary).

Exclusion criteria

Exclusion criteria: •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 the prefab spring-like AFOs; •Weakness of the knee extensor muscles, for which a knee-ankle foot orthosis is indicated

Design outcomes

Primary

MeasureTime frame
The main outcome parameters will be the maximal ankle plantarflexion angle, ankle angular velocity and knee flexion angle during the loading response.

Secondary

MeasureTime frame
Secondary outcomes will include ankle power, walking energy cost, walking speed, walking and standing balance, perceived walking safety, fatigue and stability, perceived functioning, and experiences with study participation and with the NEURO SWING AFO.

Countries

Netherlands

Contacts

Public ContactM.A. Brehm

Amsterdam UMC

m.a.brehm@amsterdamumc.nl020-5664049

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)