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Study of Wearable Interventions for Improving Mobility of Individuals With Knee Osteoarthritis

11. juni 2026 opdateret af: Christopher Shallal, Massachusetts Institute of Technology
Knee osteoarthritis (OA) affects an estimated 654 million people over age 40 world-wide. In the United States, approximately 16% of adults over the age of 40 have knee OA. Pain, activity limitations and disability are common symptoms. Exercise is widely recommended as a non-invasive, first line strategy for people with knee OA. Yet, less than 1/3 of adults with knee OA meet recommended levels of physical activity, and rates are even lower among people who are overweight. Furthermore, adherence to evidence-based structured programs is poor once the therapeutic support is removed. End stage disease is treated by total joint replacement. Under-active people with knee OA would benefit from general walking activity, even if joint replacement surgery is expected; however, walking is difficult and motivation is low. Thus, people with knee OA encounter a difficult paradox: exercise could help decrease pain and improve function but doing so can be difficult and may not always be possible. There is a tremendous need to address this situation. This is a small device-feasibility study evaluating the Dephy ExoBoot, a wearable powered exoskeleton, in individuals with knee OA. The study assesses whether the device can reliably deliver positive assistance during walking and is tolerated across walking tasks. Additional measures, including changes in knee loading and walking speed with versus without the device, are also collected.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

9

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Christopher Shallal, B.S.
  • Telefonnummer: 704-904-6112
  • E-mail: cshallal@mit.edu

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Cambridge, Massachusetts, Forenede Stater, 02139
        • Rekruttering
        • MIT Media Lab
        • Kontakt:
          • Christopher Shallal, B.S.
          • Telefonnummer: 704-904-6112

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Any gender
  • 21+ years of age
  • Doctor-diagnosed tibiofemoral knee osteoarthritis
  • Self-report knee pain or stiffness on most days of the past month
  • Self-report of difficulty walking due to at least one knee
  • Self-report of restricted walking behavior (not engaging in 150 minutes of moderate walking a week) due to at least in part one knee
  • Able to walk one block without the use of an assistive device (e.g. a cane or walker)
  • Able to engage in a walking activity program with the wearable intervention for approximately 30 minutes using standing or sitting rests as needed

Exclusion Criteria:

  • Unable to walk at least 10 minutes in the community due to an existing cardiovascular, cardiopulmonary, musculoskeletal, or neurological condition
  • Planning knee, hip, ankle or back surgery within the next 6-months
  • Ankle or hip osteoarthritis
  • Inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, scleroderma, Lymes Disease, Lupus)
  • Bilateral total knee replacements
  • Use of an assistive device (e.g., walker or cane) in home or in the community
  • Self-reported fall within the past 6-months that resulted in limitations in daily activities
  • Lower extremity/foot peripheral neuropathy or other sensory disorders
  • Diagnosed with vestibular or other balance disorder that impact walking
  • Open wounds or active skin irritation on the leg shank
  • Open wounds or active ulcers of either feet
  • Unstable cardiovascular disease
  • Unstable respiratory disease
  • History of past or current deep vein thrombosis
  • Active back pain that limits walking
  • Use of supplemental oxygen to walk

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Enhedens gennemførlighed
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Wearable Intervention for Individuals with Knee Osteoarthritis
Participants wear the Dephy ExoBoot, a powered wearable exoskeleton, while completing walking tasks. Non-invasive sensors and motion capture monitor gait and device performance, and device assistance settings may be adjusted during sessions.
Enhed: Dephy Exoboot
Individuals administered the wearable intervention will have the device accurately predict appropriate dynamics based on non-invasive sensor inputs, adapt assistance timing and magnitude to match individual gait patterns, demonstrate reliable performance across various walking conditions and provide assistance that integrates naturally with the user's biomechanics

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants that Complete Walking Protocol with Real-time Device Assistance
Tidsramme: Up to 4 sessions across 4 weeks, each lasting up to 2 days.
Number of participants that complete the walking protocol with device providing assistance without device-related restrictions.
Up to 4 sessions across 4 weeks, each lasting up to 2 days.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak external knee adduction moment
Tidsramme: Up to 4 sessions across 4 weeks, each lasting up to 2 days.
Quantitative analysis of knee adduction moment (N*m / kg) between device and no device condition.
Up to 4 sessions across 4 weeks, each lasting up to 2 days.
Change in self-selected walking speed
Tidsramme: Up to 4 sessions across 4 weeks, each lasting up to 2 days.
Analysis of walking speed (m/s) changes between device and no device conditions
Up to 4 sessions across 4 weeks, each lasting up to 2 days.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Massachusetts Institute of Technology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. december 2025

Primær færdiggørelse (Anslået)

1. juli 2028

Studieafslutning (Anslået)

1. juli 2029

Datoer for studieregistrering

Først indsendt

27. februar 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2505001645

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

IPD will not be available as it may contain identifying information.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Knæ slidgigt

Kliniske forsøg med Dephy Exoboot

Søg i lignende forsøg

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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