Contribution of an Off-the-shelf Carbon Ankle Foot Orthosis (AFO) in the Management of Walking Functional Impairment

NCT05131399 | Recruiting

• 1 other identifier: 2021-A02115-36
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 8

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.

Conditions

Neuropathy (Disorder)

Keywords

orthosis; functional walking impairment; foot drop; rehabilitation; GAS

Outcome Measures

Primary Outcomes (1)

• Comparison of the ability to achieve personal goals while wearing carbon or standard plastic ankle foot orthosis

  Personal goals achievement is evaluated via the Goal attainment scaling (GAS). Before starting the study, three personal objectives are defined according to patients needs and investigator review. Raw scores ranging from -3 (degradation) to +2 (maximum achievement of the objective) are defined: "-3" corresponding to degradation "-2" corresponding to the initial state "-1" corresponding to a partial objective achievement "0" corresponding to the total objective achievement "+1" corresponding to a better objective achievement "+2" corresponding to the maximum objective achievement. The GAS is filled 3 times a week during 12 weeks.

  3 times a week during 12 weeks

Secondary Outcomes (10)

• Comparison of patients mobility while wearing carbon or standard plastic ankle foot orthosis

  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).

• Comparison of patients walking perimeter while wearing carbon or standard plastic ankle foot orthosis

  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)

• Comparison of patients fatigue while wearing carbon or standard plastic ankle foot orthosis

  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)

• Comparison of patients stability while wearing carbon or standard plastic ankle foot orthosis

  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)

• Comparison of patients disability evolution according to the investigator while wearing carbon or standard plastic ankle foot orthosis

  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)

Study Arms (1)

Self-comparison

EXPERIMENTAL

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.

Device: Phase A1; Device: Phase B1; Device: Phase A2; Device: Phase B2

Interventions

Phase A1 DEVICE

Plastic standard ankle foot orthosis

Self-comparison

Phase B1 DEVICE

carbon medical device ankle foot orthosis

Self-comparison

Phase A2 DEVICE

Plastic standard ankle foot orthosis

Self-comparison

Phase B2 DEVICE

carbon medical device ankle foot orthosis

Self-comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Thuasne: lead

Study Sites (8)

Ch Les Capucins

Angers, France

RECRUITING

Chu Dijon

Dijon, France

RECRUITING

CH LAVAL

Laval, France

RECRUITING

CHU Lille

Lille, France

RECRUITING

centre Louis PIERQUIN

Nancy, France

NOT YET RECRUITING

CHU Nantes

Nantes, France

RECRUITING

Hôpital Rothschild

Paris, France

RECRUITING

CHU Strasbourg

Strasbourg, France

NOT YET RECRUITING

Related Publications (5)

• 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.

  PMID: 29253607 BACKGROUND

• 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.

  PMID: 26849231 BACKGROUND

• 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.

  PMID: 24315710 BACKGROUND

• 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.

  PMID: 20863658 BACKGROUND

• 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.

  PMID: 15602344 BACKGROUND

MeSH Terms

Conditions

Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Philippe THOUMIE, MD PhD

  Hôpital Rothschild (Paris)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe THOUMIE, MD PhD

CONTACT

(0)140193534; philippe.thoumie@aphp.fr

Astrid PICOLET

CONTACT

(0)640392490; astrid.picolet@thuasne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 23, 2021
• Study Start: February 28, 2022
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)