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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThuasne

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Phase A1
  • Phase B1
  • Phase A2
  • Phase B2

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators