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

THUASNE

Status: Enrolling

Conditions: Neuropathy (Disorder)

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05131399

2021-A02115-36

Details and patient eligibility

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Self-comparison

Experimental group

Description:

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.

Treatment:

Device: Phase A2

Device: Phase A1

Device: Phase B2

Device: Phase B1