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 range

11 Years – 65 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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