Study of Wearable Interventions for Improving Mobility of Individuals With Knee Osteoarthritis
11 juni 2026 uppdaterad av: 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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Beräknad)
9
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Christopher Shallal, B.S.
- Telefonnummer: 704-904-6112
- E-post: cshallal@mit.edu
Studieorter
-
-
Massachusetts
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Cambridge, Massachusetts, Förenta staterna, 02139
- Rekrytering
- MIT Media Lab
-
Kontakt:
- Christopher Shallal, B.S.
- Telefonnummer: 704-904-6112
-
-
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
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Enhetens genomförbarhet
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
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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
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants that Complete Walking Protocol with Real-time Device Assistance
Tidsram: Up to 4 sessions across 4 weeks, each lasting up to 2 days.
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Number of participants that complete the walking protocol with device providing assistance without device-related restrictions.
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Up to 4 sessions across 4 weeks, each lasting up to 2 days.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Peak external knee adduction moment
Tidsram: Up to 4 sessions across 4 weeks, each lasting up to 2 days.
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Quantitative analysis of knee adduction moment (N*m / kg) between device and no device condition.
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Up to 4 sessions across 4 weeks, each lasting up to 2 days.
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Change in self-selected walking speed
Tidsram: Up to 4 sessions across 4 weeks, each lasting up to 2 days.
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Analysis of walking speed (m/s) changes between device and no device conditions
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Up to 4 sessions across 4 weeks, each lasting up to 2 days.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
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)
15 december 2025
Primärt slutförande (Beräknad)
1 juli 2028
Avslutad studie (Beräknad)
1 juli 2029
Studieregistreringsdatum
Först inskickad
27 februari 2026
Först inskickad som uppfyllde QC-kriterierna
11 juni 2026
Första postat (Faktisk)
17 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2505001645
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
IPD will not be available as it may contain identifying information.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
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 .