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New treatment option for Neuropathy (Disorder)
Official title Contribution of an Off-the-shelf Carbon Ankle Foot Orthosis (AFO) in the Management of Walking Functional Impairment
ClinicalTrials.gov ID: NCT05131399
What this study is testing
- What it's testing
- The objective of this study is to assess the superiority in achieving personal goals (set by the patient and the medical team) according to the GAS scale (Goal Attainment Scaling) while wearing the carbon medical device Ankle Foot Orthosis (AFO) compared to a standard plastic ankle foot orthosis.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient with a foot levator muscles impairment (single or bilateral drop foot) and / or instability of the back of the foot, associated with a...
- Patient with inability to stand on tip-toe on one foot
- Patient having signed a free and informed consent
- Patient affiliated or entitled to a social security scheme
You likely can't join if
- Patient with fixed varus-equine foot
- Patient with an unstable skin condition (whether or not treated with additional treatment that may change the footwear)
- Patient with a a foot levator muscles impairment with a deficiency of the quadriceps and hamstrings (knee involvement)
- Patient with uncontrolled spasticity
- Patient for whom foot surgery is planned during the study
- Patient with one of the contraindications to the use of carbon medical device, indicated in the instructions for use
See the full eligibility criteria
- Patient with a foot levator muscles impairment (single or bilateral drop foot) and / or instability of the back of the foot, associated with a deficit of the triceps
- Patient with inability to stand on tip-toe on one foot
- Patient having signed a free and informed consent
- Patient affiliated or entitled to a social security scheme
- Patient with fixed varus-equine foot
- Patient with an unstable skin condition (whether or not treated with additional treatment that may change the footwear)
- Patient with a a foot levator muscles impairment with a deficiency of the quadriceps and hamstrings (knee involvement)
- Patient with uncontrolled spasticity
- Patient for whom foot surgery is planned during the study
- Patient with one of the contraindications to the use of carbon medical device, indicated in the instructions for use
- Patient with one of the contraindications to the use of the standard plastic ankle foot orthosis, indicated in the instructions for use
- Patient with orthopedic comorbidities affecting the musculoskeletal system
- Pregnant woman
- Patient with major cognitive impairment incompatible with participation in a clinical trial
- Patient participating in another clinical investigation conducted to establish the compliance of a MD impacting the evaluation criteria
- Patient who cannot be followed for 12 weeks
- Vulnerable patient according to article L1121-6 of the public health code, persons subject to a measure of judicial protection or unable to consent freely
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Dijon, France
- Laval, France
- Lille, France
- Nancy, France
- Nantes, France
- Paris, France
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Dijon, France; Laval, France; Lille, France; Nancy, France; Nantes, France and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.