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

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Massachusetts Institute of Technology
Study ID
NCT07652437
Status
Recruiting
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Conditions

  • Knee Osteoarthristis

Eligibility Criteria

Sex
ALL
Age
21 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Dephy Exoboot — DEVICE
    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

Study Details

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.

Key Dates

Start date
Dec 15, 2025
Status verified
Jun 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2029

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: 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.

Primary Outcome Measure

Number of Participants that Complete Walking Protocol with Real-time Device Assistance [ Time Frame: Up to 4 sessions across 4 weeks, each lasting up to 2 days. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MIT Media LabCambridgeMassachusetts02139
Christopher Shallal, B.S.
704-904-6112

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By research site
MIT Media Lab· Cambridge, MA

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