Contribution of an Off-the-shelf Carbon Ankle Foot Orthosis (AFO) in the Management of Walking Functional Impairment
NCT ID: NCT05131399
Last Updated: 2024-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2022-02-28
2024-11-30
Brief Summary
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Detailed Description
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The current medical strategy focuses on various off-the-shelf or custom made devices, depending on the walking functional impairment and the characteristics of foot deformities.
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 compared to a standard plastic ankle foot orthosis.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Self-comparison
Patients will be fitted with 2 types of ankle foot orthoses, alternately, divided into 4 phases, in the following order:
Phase A1: Standard Plastic ankle foot orthosis Phase B1: carbon medical device ankle foot orthosis Phase A2: Standard Plastic ankle foot orthosis Phase B2: carbon medical device ankle foot orthosis Each patient is his own comparator. For all patients, the total duration of the study will be the same, and will correspond to 12 weeks.
Phase A1
Plastic standard ankle foot orthosis
Phase B1
carbon medical device ankle foot orthosis
Phase A2
Plastic standard ankle foot orthosis
Phase B2
carbon medical device ankle foot orthosis
Interventions
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Phase A1
Plastic standard ankle foot orthosis
Phase B1
carbon medical device ankle foot orthosis
Phase A2
Plastic standard ankle foot orthosis
Phase B2
carbon medical device ankle foot orthosis
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Thuasne
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe THOUMIE, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Rothschild (Paris)
Locations
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Ch Les Capucins
Angers, , France
Chu Dijon
Dijon, , France
CH LAVAL
Laval, , France
CHU Lille
Lille, , France
centre Louis PIERQUIN
Nancy, , France
CHU Nantes
Nantes, , France
Hôpital Rothschild
Paris, , France
CHU Strasbourg
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Yoann Ronzi, MD
Role: primary
Nawale HADOUIRI, MD
Role: primary
Romain Champagne, MD
Role: primary
Vincent TIFFREAU, MD PhD
Role: primary
Isabelle LOIRET, MD
Role: primary
Raphaël Gross, PhD, MD
Role: primary
Amandine HELFER, MD
Role: primary
References
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Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
Barreto LC, Oliveira FS, Nunes PS, de Franca Costa IM, Garcez CA, Goes GM, Neves EL, de Souza Siqueira Quintans J, de Souza Araujo AA. Epidemiologic Study of Charcot-Marie-Tooth Disease: A Systematic Review. Neuroepidemiology. 2016;46(3):157-65. doi: 10.1159/000443706. Epub 2016 Feb 6.
Gholizadeh H, Abu Osman NA, Eshraghi A, Ali S, Razak NA. Transtibial prosthesis suspension systems: systematic review of literature. Clin Biomech (Bristol). 2014 Jan;29(1):87-97. doi: 10.1016/j.clinbiomech.2013.10.013. Epub 2013 Oct 29.
Zucker DR, Ruthazer R, Schmid CH. Individual (N-of-1) trials can be combined to give population comparative treatment effect estimates: methodologic considerations. J Clin Epidemiol. 2010 Dec;63(12):1312-23. doi: 10.1016/j.jclinepi.2010.04.020. Epub 2010 Sep 22.
Spieler JF, Amarenco P. [Socio-economic aspects of stroke management]. Rev Neurol (Paris). 2004 Nov;160(11):1023-8. doi: 10.1016/s0035-3787(04)71139-x. French.
Other Identifiers
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2021-A02115-36
Identifier Type: -
Identifier Source: org_study_id
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