Clinical trial NCT05131399: Contribution of an Off-the-shelf Carbon Ankle Foot Orthosis (AFO) in the Management of Walking Functional Impairment
Official title: Single Case Experimental Design (SCED) Comparing an Off-the-shelf Carbon Ankle Foot Orthosis (SPRYSTEP) Versus an off-the Shelf Standard Plastic Ankle Foot Orthosis in the Treatment of Walking Functional Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathy (Disorder)
Keywords: orthosis
functional walking impairment
foot drop
rehabilitation
GAS
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Prospective, multicenter, interventional study, SCED design in ABAB introduction/withdrawal. The timing of the transition from one phase to the next will be randomized. The duration of each of the phases (A1, B1, A2, B2) will therefore be defined randomly, while maintaining a total duration of 12 weeks for each study schema.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Foot drop is a symptom observed in various pathologies including neuro-muscular pathologies of peripheral or central origin. It is a walking disability, causing a deterioration in the patients autonomy and quality of life.

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.

Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparison of the ability to achieve personal goals while wearing carbon or standard plastic ankle foot orthosis
timeFrame: 3 times a week during 12 weeks
Secondary outcomes:
measure: Comparison of patients mobility while wearing carbon or standard plastic ankle foot orthosis
timeFrame: Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12).
measure: Comparison of patients walking perimeter while wearing carbon or standard plastic ankle foot orthosis
timeFrame: Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12)
measure: Comparison of patients fatigue while wearing carbon or standard plastic ankle foot orthosis
timeFrame: Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12)
measure: Comparison of patients stability while wearing carbon or standard plastic ankle foot orthosis
timeFrame: Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12)
measure: Comparison of patients disability evolution according to the investigator while wearing carbon or standard plastic ankle foot orthosis
timeFrame: Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12)
measure: Comparison of patients disability evolution according to the patient while wearing carbon or standard plastic ankle foot orthosis
timeFrame: Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12)
measure: Comparison of pain, gait and balance evolution according to the patient while wearing carbon or standard plastic ankle foot orthosis
timeFrame: Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12)
measure: Comparison of tolerance of carbon and standard plastic ankle foot orthosis
timeFrame: Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12)
measure: Comparison of acceptability and compliance with carbon and standard plastic ankle foot orthosis
timeFrame: Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12)
measure: Patients satisfaction with carbon and standard plastic ankle foot orthosis
timeFrame: V4 at 12 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: Ch Les Capucins
city: Dijon
country: France
facility: Chu Dijon
city: Laval
country: France
facility: CH LAVAL
city: Lille
country: France
facility: CHU Lille
city: Nancy
country: France
facility: centre Louis PIERQUIN
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hôpital Rothschild
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
affiliation: Hôpital Rothschild (Paris)
name: Philippe THOUMIE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.