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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Phase A1

    Device

    Plastic standard ankle foot orthosis

  • Phase B1

    Device

    carbon medical device ankle foot orthosis

  • Phase A2

    Device

    Plastic standard ankle foot orthosis

  • Phase B2

    Device

    carbon medical device ankle foot orthosis

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Self-comparisonExperimental treatment 4 interventions

Trial outcomes

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.

Time frame
3 times a week during 12 weeks

Secondary outcomes

1

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

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

Time frame
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).
2

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

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

Time frame
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)
3

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

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").

Time frame
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)
4

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

Patient's stability is assessed by 2 means: 1. 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. 2. via the number of falls recorded during each phase and their context

Time frame
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)

Other outcomes

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