CompletedNot Applicable

Comparison of Conventionally Manufactured AFO and Modular Customized AFO

Switzerland15 participantsStarted 2022-02-25

Plain-language 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.

Who can participate

Age range11 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Gait Profile Score (GPS)

Timeframe: immediately after the intervention (gait analysis)

Trial details

NCT IDNCT05192915

SponsorBeat Göpfert

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Gait, Drop Foot trials