the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle V… (NCT03668561) | Clinical Trial Compass
TerminatedNot Applicable
the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus
Stopped: COVID
France5 participantsStarted 2019-02-22
Plain-language summary
To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.
Who can participate
Age range
18 Years – 80 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:
* Hemiparesis at \> 3 months (whatever the etiology)
* varus or equinovarus foot disturbing the stance phase of gait
* Able to walk at least 10m, with or without assistive device
Exclusion Criteria:
* unable to walk 10m
* Botulinum toxin injection less than 3 months before inclusion
* history of neurological or locomotor pathology in addition to the etiology of hemiparesis
* Severe comprehension troubles
* 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.
1This trial was terminated before completing — do you know why it ended early, and does that affect whether the CALIGALOC orthosis is still considered a viable option for my ankle varus and hemiparesis?
2Since the main thing this trial was measuring was how fast patients could walk 10 meters, what do the partial results — if any are available — suggest about whether this type of orthosis actually improves walking speed for someone with my level of hemiparesis?
3This trial has no phase designation, which often means it's more of a feasibility or device-testing study rather than a large treatment trial — does that mean there's still limited evidence on how safe and effective the CALIGALOC orthosis is compared to standard ankle-foot orthoses I might already be eligible for?
4Given that this study was terminated, are there other active trials or established treatments for hemiparesis-related ankle varus that you'd recommend I look into instead?
5Would trying the CALIGALOC orthosis outside of a clinical trial be an option for me, or is access to it dependent on participating in research?
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
1
10-meter walk test (in seconds)
Timeframe: comparison between baseline and 15 days