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Neuropathy (Disorder)DEFISTEPNCT05131399

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

A study testing Phase A1, Phase B1 and Phase A2 in people with Neuropathy (Disorder), run by Thuasne at 8 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuropathy (Disorder)
What is being tested?
Phase A1, Phase B1 and Phase A2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
8 sitesFrance
Study dates
28 Feb 2022to Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

Philippe THOUMIE, MD PhD contact

(0)140193534 ext. +33

philippe.thoumie@aphp.fr

Astrid PICOLET contact

(0)640392490 ext. +33

astrid.picolet@thuasne.fr

8 sites in 1 country

France8 sites, 8 recruiting

  • Ch Les Capucins

    Angers

    Yoann Ronzi, MD

    Recruiting

  • Chu Dijon

    Dijon

    Nawale HADOUIRI, MD

    Recruiting

  • CH LAVAL

    Laval

    Romain Champagne, MD

    Recruiting

  • CHU Lille

    Lille

    Vincent TIFFREAU, MD PhD

    Recruiting

  • centre Louis PIERQUIN

    Nancy

    Isabelle LOIRET, MD

    Not yet recruiting

  • CHU Nantes

    Nantes

    Raphaël Gross, PhD, MD

    Recruiting

  • Hôpital Rothschild

    Paris

    Philippe THOUMIE, MD PhD, (0)140193534 ext. +33, philippe.thoumie@aphp.fr

    Recruiting

  • CHU Strasbourg

    Strasbourg

    Amandine HELFER, MD

    Not yet recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Phase A1, Phase B1, Phase A2, Phase B2
Keywords
orthosis, functional walking impairment, foot drop, rehabilitation, GAS
Medical subject headings
Peroneal Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phase A1Device

    Plastic standard ankle foot orthosis

  • Phase B1Device

    carbon medical device ankle foot orthosis

  • Phase A2Device

    Plastic standard ankle foot orthosis

  • Phase B2Device

    carbon medical device ankle foot orthosis

Study groups in NCT05131399
Study groupRoleWhat they receive
Self-comparisonExperimentalPatients 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.
Receives: Device: Phase A1; Device: Phase B1; Device: Phase A2; Device: Phase B2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 times a week during 12 weeks

Secondary outcomes (10)

  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

    Measured: 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.

    Measured: 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").

    Measured: 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

    Measured: 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)

  5. Comparison of patients disability evolution according to the investigator while wearing carbon or standard plastic ankle foot orthosis

    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.

    Measured: 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)

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

    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.

    Measured: 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)

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

    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).

    Measured: 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)

  8. Comparison of tolerance of carbon and standard plastic ankle foot orthosis

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

    Measured: 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)

  9. Comparison of acceptability and compliance with carbon and standard plastic ankle foot orthosis

    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.

    Measured: 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)

  10. Patients satisfaction with carbon and standard plastic ankle foot orthosis

    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.

    Measured: V4 at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2021
  2. Study start28 Feb 2022
  3. Primary completionSep 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
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.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05131399
Sponsor's protocol ID
2021-A02115-36
Acronym
DEFISTEP
Status last verified
Sep 2024
First submitted
29 Oct 2021
Last updated
23 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.

    PubMed 29253607

  • Barreto LC, Oliveira FS, Nunes PS, de Franca Costa IM, Garcez CA, Goes GM, Neves EL, de Souza Siqueira Quintans J, de Souza Araujo AA. Epidemiologic Study of Charcot-Marie-Tooth Disease: A Systematic Review. Neuroepidemiology. 2016;46(3):157-65. doi: 10.1159/000443706. Epub 2016 Feb 6.

    PubMed 26849231

  • Gholizadeh H, Abu Osman NA, Eshraghi A, Ali S, Razak NA. Transtibial prosthesis suspension systems: systematic review of literature. Clin Biomech (Bristol). 2014 Jan;29(1):87-97. doi: 10.1016/j.clinbiomech.2013.10.013. Epub 2013 Oct 29.

    PubMed 24315710

  • Zucker DR, Ruthazer R, Schmid CH. Individual (N-of-1) trials can be combined to give population comparative treatment effect estimates: methodologic considerations. J Clin Epidemiol. 2010 Dec;63(12):1312-23. doi: 10.1016/j.jclinepi.2010.04.020. Epub 2010 Sep 22.

    PubMed 20863658

  • Spieler JF, Amarenco P. [Socio-economic aspects of stroke management]. Rev Neurol (Paris). 2004 Nov;160(11):1023-8. doi: 10.1016/s0035-3787(04)71139-x. French.

    PubMed 15602344

Questions about this trial

What is this clinical trial studying?

A study testing Phase A1, Phase B1 and Phase A2 in people with Neuropathy (Disorder), run by Thuasne at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Philippe THOUMIE, MD PhD ((0)140193534 ext. +33, philippe.thoumie@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the ability to achieve personal goals while wearing carbon or standard plastic ankle foot orthosis (time frame: 3 times a week during 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05131399, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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