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

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.

Mobility is evaluated via staircase tests: Time (in minutes) to go up and down 10 steps

Walking perimeter is evaluated via the Six-minute walk test (6MWT), that measures the distance (in meters) during a 6 minutes walk.

Patient's fatigue perception is assessed by the patient via the Borg Rating of Perceived Exertion (RPE) scale following mobility and walking perimeter tests The effort rating is based on a scale of 6 to 20 (6, which is "no effort", to 20, which is "maximum effort").

Patient's stability is assessed by 2 means:

• via the Timed Up and Go test : time (in seconds) to realize the test. The patient should stand up from a chair, walk a distance of three meters, turn around, then walk back to the chair and sit down. These tasks should be performed at a comfortable and safe speed.
• via the number of falls recorded during each phase and their context

Doctors' opinion on the Patients disability evolution is measured by the Clinical Global Impression - Improvement (CGI-I) questionnaire.

The scale has 7 levels of answer from "very strongly improved" which is the better outcome (= 1 point) to "very strongly aggravated" which is the worst outcome (= 7 points) .Intermediate levels are: " Significantly improved "(= 2 points) ; " Slightly improved " (= 3 points) ; " No improvement " (=4 points) ; " Slightly worsen " (=5 points) ; " Seriously worsen" ( = 6 points).

The highest score corresponds to the most impairment in quality of life.

Patient's opinion on his disability evolution is measured by the Global Impression of Change (PCI-C).

The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference ( better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference.

Pain level is measured by Visual Analogic Scale (VAS) completed by the patient : 0 corresponds to no pain (better outcome) and 10 to maximum pain (worst outcome).

Natural gait and confidence in walking are measured by Visual Analogic Scale (VAS) completed by the patient : 0 corresponds to no natural gait or no confidence (worst outcome) and 10 to better natural gait and better confidence (better outcome).

Balance is measured by Visual Analogic Scale (VAS) completed by the patient : 0 corresponds to no balance (worst outcome) and 10 to maximum balance (better outcome).

Tolerance is measured by reported adverse events. Number and type of serious and non-serious Adverse Device Effects (ADE) are reported.

Cumulative wearing time of the devices under study (indicated by a thermal button inserted into the device) is collected during each phase. Specific questions on compliance are also asked by the investigator to the patient during the various visits.

Patients satisfaction is evaluated at the end of phase B2 regarding the use of the study devices via the "Technology" part of the evaluation towards a technical aid questionnaire (8 questions) and a specific questionnaire.