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Clinical Validation of a Mobility Monitor to Measure and Predict Health Outcomes (MOBILISE-D)

17 november 2021 uppdaterad av: University Hospital, Montpellier

Validating Digital Mobility Assessment Using Wearable Technology - the Mobilide-D Clinical Validation Study

Background and study aims The ability to move is important for general well-being. Ageing and chronic health conditions can lead to a loss of mobility and a loss of independence. In order to treat mobility loss, tools are needed that can detect and accurately measure mobility. Existing measures of mobility (based on self-reporting and one-off tests) are highly limited. Wearable digital technology (a small device worn on the body) that can be used in the home and the community can provide a simple, accurate and low-cost measure of mobility. The researchers have validated a wearable mobility monitor which can accurately measure how well a person walks by measuring aspects of mobility such as speed and symmetry. The aim of this study is to investigate the ability of the mobility monitor to measure and predict outcomes in proximal femoral fracture (PFF) patients. The digital assessment of mobility developed in this study will be used in clinical trials and in clinical practice.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

The study plans to include patients in two groups, both acute (during hospital stay after hip fracture) and subacute (up to 6 months post hip fracture from waiting lists). With this strategy, it is possible to have the life-course of PFF (first 12 months and the time after). Acute phase inclusion is defined as inclusion start on first days after surgery and will be completed within the first 14 days. Subacute phase inclusion is defined as inclusion from waiting lists, where baseline will be conducted up to 6 months after hip fracture surgery.

Fear of falling will be tested using a single question during the acute phase and the short form of the fall efficacy scale international (Short FES-I) for all other assessments. For the acute recruited group of patients (2/3 of included participants), sensor recordings will be made on patients from hospital stay (attached on day 2 after surgery) and continue after discharge (until day 9 depending on battery capacity of the sensors) to be able to monitor and describe DMOs from about 2 days during hospital stay and several days after discharge to be able to evaluate improvement during the acute rehabilitation process. For all other assessments, sensor recordings will be collected for a minimum of 7 full continuous days in line with the core data collection manual.

Hip fracture patients will be tested for sarcopenia according to the updated definitions of the European and US-American working groups. In centers where bioimpedance measurements are possible, participants will receive this measurement as part of the core data collection.

Studietyp

Observationell

Inskrivning (Förväntat)

150

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Frankrike
      • Montpellier, Frankrike, 34295
        • Rekrytering
        • Centre Hospitalier Universitaire de Montpellier
        • Kontakt:
        • Kontakt:
        • Underutredare:
          • François CANOVAS, PD PH
        • Underutredare:
          • Louis DAGNEAUX, PD
      • Montpellier, Frankrike, 34000
        • Rekrytering
        • Polyclinique Saint-Roch
        • Kontakt:
          • Marion Bertrand Marchand, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

45 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

The investigators will recruit two groups, both acute (during hospital stay after hip fracture) and subacute (up to 6 months post hip fracture from waiting lists). With this strategy the investigators will not only have one segment of the disease, but the life-course of PFF (first 12 months and the time after). Acute phase inclusion is defined as inclusion start on first days after surgery and will be completed within the first 14 days. Subacute phase inclusion is defined as inclusion from waiting lists, where baseline will be conducted up to 6 months after hip fracture surgery.

Beskrivning

Inclusion Criteria:

  • Aged 45 or over
  • Surgical treatment (fixation or arthroplasty) for a low-energy fracture of the proximal femur (ICD-10 diagnosis S72.0, S72.1, S72.2) as diagnosed on X-rays of the hip and pelvis. Between 3 days and 52 weeks post-surgery

  • be able to walk 4 meters

    -.be available for 24 months following the fracture,

  • be able to read and understand the briefing note and complete questionnaires feedback
  • express their will and sign a consent to participate in follow-up testing, and to wear the motion sensor
  • The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

Occurrence of one of the following events in the 3 months preceding the consent enlightened

  1. subject with a history of myocardial infarction,
  2. Subject hospitalized for unstable angina,
  3. Subject with a history of stroke,
  4. Subject with a history of coronary bypass surgery (PAC),
  5. Subject having had percutaneous coronary intervention (PCI),

  6. Subject having had a cardiac resynchronization therapy device implanted (CRTD),

    - Other criteria for non-inclusions

  7. Subject with active treatment for cancer or other malignant disease,
  8. Subject with uncontrolled congestive heart disease (NYHA class> 3),
  9. Subject with acute psychosis or major psychiatric disorders
  10. Subject with continued drug addiction.
  11. Subject unable to walk prior to hip fracture treatment.
  12. The patient is participating in another interventional category I study,
  13. l All categories of persons particularly protected under the law French (adults under guardianship, guardianship or safeguard of justice…. articles L1121-8 - L1121-5 - L1121-6 - L1121-7 - L1121-9 of the Health Code Public)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in the functional component score of the Late-Life Functional Disability Index (LLFDI), that goes from 0 to 100, during 24 months follow-up.
Tidsram: 24 months
Measured at baseline, 6, 12, 18 and 24 months
24 months
Admission to a care home
Tidsram: 6 months
Assessed from patient records at 6 months follow-up
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Montpellier

Samarbetspartners

Newcastle-upon-Tyne Hospitals NHS Trust

Utredare

  • Huvudutredare: Hubert Blain, PD PH, University Hospital, Montpellier

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 oktober 2021

Primärt slutförande (Förväntat)

4 oktober 2022

Avslutad studie (Förväntat)

12 oktober 2024

Studieregistreringsdatum

Först inskickad

6 maj 2021

Först inskickad som uppfyllde QC-kriterierna

31 maj 2021

Första postat (Faktisk)

2 juni 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 november 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 november 2021

Senast verifierad

1 november 2021

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RECHMPL20_0700

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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