CompletedNot Applicable

Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop

Canada18 participantsStarted 2021-07-19

Plain-language summary

The objective of this research is to compare the new ankle foot orthosis (AFO) with prior support developed by Turbomed, with the AFO with posterior support from Turbomed as well as two competing AFOs currently on the market. With this research, we seek to answer the following questions: * Is the new AFO as biomechanically efficient as the AFOs currently on the market? * Is the new AFO more comfortable than the AFO currently on the market? * Is the new AFO easier to put on and attach than the AFOs currently on the market?

Who can participate

Age range

18 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: * Foot drop following surgery or an accident (functional calf, without contracture and not spastic) * Foot drop following a Cerebral Vascular Accident (with or without spasticity, mild to moderate) * Ability to stand and walk alone without technical assistance * Ability to communicate comfort/discomfort Exclusion Criteria: * Sore to one of the feet

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

Knee flexion angle during gait

Timeframe: At delivery

Hip flexion angle during gait

Timeframe: At delivery

Minimum foot clearance

Timeframe: At delivery

Comfort of participants with orthosis

Timeframe: At delivery

Easy to put on orthosis

Timeframe: At delivery

Trial details

NCT IDNCT05163782

SponsorTOPMED

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More Foot Drop trials

Plain-language summary

Who can participate

Age range

18 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.