Neuropathy (Disorder)
Conditions
Keywords
orthosis, functional walking impairment, foot drop, rehabilitation, GAS
Brief 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.
Detailed 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.
Interventions
DEVICEPhase A1
Plastic standard ankle foot orthosis
DEVICEPhase B1
carbon medical device ankle foot orthosis
DEVICEPhase A2
Plastic standard ankle foot orthosis
DEVICEPhase B2
carbon medical device ankle foot orthosis
Sponsors
Thuasne
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicenter, interventional study, SCED design in ABAB introduction/withdrawal. The timing of the transition from one phase to the next will be randomized. The duration of each of the phases (A1, B1, A2, B2) will therefore be defined randomly, while maintaining a total duration of 12 weeks for each study schema.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the ability to achieve personal goals while wearing carbon or standard plastic ankle foot orthosis | 3 times a week during 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of patients walking perimeter while wearing carbon or standard plastic ankle foot orthosis | 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) | Walking perimeter is evaluated via the Six-minute walk test (6MWT), that measures the distance (in meters) during a 6 minutes walk. |
| Comparison of patients fatigue while wearing carbon or standard plastic ankle foot orthosis | 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) | 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). |
| Comparison of patients stability while wearing carbon or standard plastic ankle foot orthosis | 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) | 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 |
| Comparison of patients disability evolution according to the investigator while wearing carbon or standard plastic ankle foot orthosis | 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) | 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. |
| Comparison of patients mobility while wearing carbon or standard plastic ankle foot orthosis | 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). | Mobility is evaluated via staircase tests: Time (in minutes) to go up and down 10 steps |
| Comparison of pain, gait and balance evolution according to the patient while wearing carbon or standard plastic ankle foot orthosis | 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) | 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). |
| Comparison of tolerance of carbon and standard plastic ankle foot orthosis | 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) | Tolerance is measured by reported adverse events. Number and type of serious and non-serious Adverse Device Effects (ADE) are reported. |
| Comparison of acceptability and compliance with carbon and standard plastic ankle foot orthosis | 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) | 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 with carbon and standard plastic ankle foot orthosis | V4 at 12 weeks | 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. |
| Comparison of patients disability evolution according to the patient while wearing carbon or standard plastic ankle foot orthosis | 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) | 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. |
Countries
France
Contacts
Primary ContactPhilippe THOUMIE, MD PhD
Backup ContactAstrid PICOLET
Outcome results
None listed