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

2022. április 26. frissítette: Thuasne

Single Case Experimental Design (SCED) Comparing an Off-the-shelf Carbon Ankle Foot Orthosis (SPRYSTEP) Versus an off-the Shelf Standard Plastic Ankle Foot Orthosis in the Treatment of Walking Functional Impairment

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.

A tanulmány áttekintése

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Várható)

20

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: N/A
  • Beavatkozó modell: Szekvenciális hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Self-comparison

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.

Plastic standard ankle foot orthosis
carbon medical device ankle foot orthosis
Plastic standard ankle foot orthosis
carbon medical device ankle foot orthosis

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Comparison of the ability to achieve personal goals while wearing carbon or standard plastic ankle foot orthosis
Időkeret: 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.

3 times a week during 12 weeks

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Comparison of patients mobility while wearing carbon or standard plastic ankle foot orthosis
Időkeret: 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
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).
Comparison of patients walking perimeter while wearing carbon or standard plastic ankle foot orthosis
Időkeret: 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.
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)
Comparison of patients fatigue while wearing carbon or standard plastic ankle foot orthosis
Időkeret: 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").
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)
Comparison of patients stability while wearing carbon or standard plastic ankle foot orthosis
Időkeret: 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
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)
Comparison of patients disability evolution according to the investigator while wearing carbon or standard plastic ankle foot orthosis
Időkeret: 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.

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)
Comparison of patients disability evolution according to the patient while wearing carbon or standard plastic ankle foot orthosis
Időkeret: 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.

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)
Comparison of pain, gait and balance evolution according to the patient while wearing carbon or standard plastic ankle foot orthosis
Időkeret: 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).

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)
Comparison of tolerance of carbon and standard plastic ankle foot orthosis
Időkeret: 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.
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)
Comparison of acceptability and compliance with carbon and standard plastic ankle foot orthosis
Időkeret: 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.
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)
Patients satisfaction with carbon and standard plastic ankle foot orthosis
Időkeret: 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.
V4 at 12 weeks

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Nyomozók

  • Kutatásvezető: Philippe THOUMIE, MD PhD, Hôpital Rothschild (Paris)

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2022. február 28.

Elsődleges befejezés (Várható)

2022. december 1.

A tanulmány befejezése (Várható)

2022. december 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2021. október 29.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2021. november 10.

Első közzététel (Tényleges)

2021. november 23.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2022. április 27.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2022. április 26.

Utolsó ellenőrzés

2022. április 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Egyéb vizsgálati azonosító számok

  • 2021-A02115-36

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

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