WithdrawnNot Applicable

Development and Validation of an Instrumented Ankle-foot Orthosis

Stopped: The instrumented orthosis prototype was never finished.

Canada0Started 2023-09-13

Plain-language summary

Foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. Foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. Dragging one's toes on an uneven floor or a carpet can lead to tripping and falling. TurboMed Orthotics Inc. has developed various orthoses for several years in order to improve the gait and quality of life for people suffering from foot drop. In order to help clinicians better monitor and assess gait parameters over time, the company wants to offer clinicians a tool for a more rigorous analysis. Thus, the objective of the proposed project is to develop a questionnaire for identifying the clinical need for the data generated by the instrumented orthosis. The instrumented orthosis will also be compared to a reference system in a validation effort.

Who can participate

Age range

18 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 for Patients questionnaire: * Having foot drop Inclusion Criteria for Clinician questionnaire: * Being a clinician who treats foot drop patients Inclusion Criteria for Gait analysis: * Having foot drop Exclusion Criteria for Gait analysis: * Not being able to walk without a cane or a walker * Having lower extremity spasticity

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 Temporal parameters

Timeframe: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session

Heel strike angle

Timeframe: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session

Gait Spatial parameters

Timeframe: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session

Gait speed

Timeframe: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session

Trial details

NCT IDNCT06115161

SponsorTOPMED

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-13

View on ClinicalTrials.gov More Foot Drop trials

Plain-language summary

Who can participate

Age range

18 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.

What they're measuring

Gait Temporal parameters

Timeframe: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session

Heel strike angle

Timeframe: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session

Gait Spatial parameters

Timeframe: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session

Gait speed

Timeframe: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session