Actively Recruiting
Contribution of an Off-the-shelf Carbon Ankle Foot Orthosis (AFO) in the Management of Walking Functional Impairment
Led by Thuasne · Updated on 2024-09-23
20
Participants Needed
8
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Contribution of an Off-the-shelf Carbon Ankle Foot Orthosis (AFO) in the Management of Walking Functional Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with a foot levator muscles impairment (single or bilateral drop foot) and/or instability of the back of the foot, with a triceps deficit
- Patient unable to stand on tip-toe on one foot
- Patient who has signed a free and informed consent
- Patient affiliated or entitled to a social security scheme
You will not qualify if you...
- Patient with fixed varus-equine foot
- Patient with unstable skin condition affecting footwear
- Patient with foot levator muscle impairment plus quadriceps and hamstrings deficiency (knee involvement)
- Patient with uncontrolled spasticity
- Patient with planned foot surgery during the study
- Patient with contraindications to carbon medical device as per instructions for use
- Patient with contraindications to standard plastic ankle foot orthosis as per instructions for use
- Patient with orthopedic comorbidities affecting the musculoskeletal system
- Pregnant woman
- Patient with major cognitive impairment incompatible with trial participation
- Patient participating in another clinical investigation affecting evaluation criteria
- Patient unable to be followed for 12 weeks
- Vulnerable patient per article L1121-6 of the public health code or unable to consent freely
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Ch Les Capucins
Angers, France
Actively Recruiting
2
Chu Dijon
Dijon, France
Actively Recruiting
3
CH LAVAL
Laval, France
Actively Recruiting
4
CHU Lille
Lille, France
Actively Recruiting
5
centre Louis PIERQUIN
Nancy, France
Not Yet Recruiting
6
CHU Nantes
Nantes, France
Actively Recruiting
7
Hôpital Rothschild
Paris, France
Actively Recruiting
8
CHU Strasbourg
Strasbourg, France
Not Yet Recruiting
Research Team
P
Philippe THOUMIE, MD PhD
CONTACT
A
Astrid PICOLET
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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