NCT05192915

Comparison of Conventionally Manufactured AFO and Modular Customized AFO

Comparison of Conventionally Manufactured Lower Leg Orthoses and Modular Customized Lower Leg Orthoses (AFO 4.0) in Patients With Limited Neuromuscular Foot Function During Overground Walking

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Beat Göpfert · Academic / Other
• Sex: All
• Age: 11 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The Investigator will investigate the difference in the gait pattern between 2 commercially available ankle foot orthoses (AFO): a) conventionally manufactured AFO and b) modular customized AFO using Industry 4.0 technology. Measurement method: The participants perform an instrumented gait analyses while overground walking at a self - selected speed using a conventionally manufactured AFO or a modular customized AFO.

Detailed description

Cerebral palsy (CP) is the most common movement disorder in children \[Stavsky, 2017\]. It is frequently accompanied by spasticity \[Baker, 2009\]. The typical symptoms of spastic cerebral palsy are gait abnormalities such as equinus and drop foot that lead to severe impairments in daily life \[Armand, 2016\]. As these symptoms will persist in adulthood, an AFO is frequently required in this patient population. Furthermore, other neurological diseases e.g stroke \[Choo, 2021\], spinal cord injury, and peripheral nerve injury may require the daily use of an AFO. Ankle-foot orthoses (AFO) have been suggested to improve the dynamic efficiency of the gait. In addition, a positive effects on gait kinetics and kinematics have been reported \[Figueiredo, 2008\]. Recently, modular customized AFO are increasingly proposed as their response can be tuned to the patient's gait characteristics and/or functional maturity \[6\]. However, the evidence on this topic is still lacking and modular customized AFO are not yet established in clinical routine. The aim of this study is to assess gait parameters with an instrumented gait analysis of the modular customized AFO compared to conventional, untuned AFO in a group of adolescents and a group of adults using for there daily activity an AFO, while over ground walking at self selected speed over a distance of about 10 m.

Conditions

• Gait, Drop Foot

Interventions

Type	Name	Description
DEVICE	Modular customized AFO	Walks better at self selected speed with a modular customized AFO than with a conventional AFO.

Timeline

• Start date: 2022-02-25
• Primary completion: 2023-12-31
• Completion: 2024-01-31
• First posted: 2022-01-14
• Last updated: 2024-12-05

Locations

1 site across 1 country: Switzerland