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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05192915
Study type Interventional
Source University of Basel
Contact Beat Goepfert, MEng, EMBA
Phone +41 61 207 54 28
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date February 1, 2022
Completion date January 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03655587 - Impact of an Orthotic Intervention in Children With Peripheral Neuropathy N/A
Completed NCT01138995 - Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop Phase 4