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

Last updated: September 20, 2024
Sponsor: Thuasne
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Phase A2

Phase B1

Phase A1

Clinical Study ID

NCT05131399
2021-A02115-36
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patient with fixed varus-equine foot

  • Patient with an unstable skin condition (whether or not treated with additionaltreatment that may change the footwear)

  • Patient with a a foot levator muscles impairment with a deficiency of the quadricepsand 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 anklefoot 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 aclinical trial

  • Patient participating in another clinical investigation conducted to establish thecompliance 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, personssubject to a measure of judicial protection or unable to consent freely

Study Design

Total Participants: 20
Treatment Group(s): 4
Primary Treatment: Phase A2
Phase:
Study Start date:
February 28, 2022
Estimated Completion Date:
November 30, 2024

Study 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.

Connect with a study center

  • Ch Les Capucins

    Angers,
    France

    Active - Recruiting

  • Chu Dijon

    Dijon,
    France

    Active - Recruiting

  • CH LAVAL

    Laval,
    France

    Active - Recruiting

  • CHU Lille

    Lille,
    France

    Active - Recruiting

  • centre Louis PIERQUIN

    Nancy,
    France

    Site Not Available

  • CHU Nantes

    Nantes,
    France

    Active - Recruiting

  • Hôpital Rothschild

    Paris,
    France

    Active - Recruiting

  • CHU Strasbourg

    Strasbourg,
    France

    Site Not Available

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