Comparison of Conventionally Manufactured AFO and Modular Customized AFO (AFO4-0)

Beat Göpfert

Status: Completed

Conditions: Gait, Drop Foot

Treatments: Device: Modular customized AFO

Study type: Interventional

Funder types: Other

Identifiers

NCT05192915

AFO4-0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 11 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants fulfilling all of the following inclusion criteria are eligible for the study:

• Patients (11-18 yrs.), who need a new orthosis (visit to an orthopedic technician)
• Patients (18-65 yrs.), who need a new orthosis (visit to an orthopedic technician)
• Informed Consent provided as documented by signature
• Confirmed diagnosis of cerebral palsy
• Confirmed diagnosis of spastic equinus and/ or drop foot,
• Gait pathologies treated with conventional AFO
• Gross Motor Function Classification System (GMFCS) level I or II

Exclusion criteria

• Other neuromuscular diseases
• Surgical intervention lower extremities past 12 months to improve gait pathologies
• Injections of Botulinum toxin 6 months prior to study inclusion
• Inability or unwillingness to follow the procedures of the gait analysis
• in women: pregnancy

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Modular customized AFO

Other group

Description:

Walks better at self selected speed with a modular customized AFO than with a conventional AFO.

Treatment:

Device: Modular customized AFO