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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthristis
• Intervention / Treatment: Device: Dephy Exoboot

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Shallal, B.S.; Phone Number: 704-904-6112; Email: cshallal@mit.edu

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139
      • Recruiting
      • MIT Media Lab
      • Contact: Christopher Shallal, B.S.; Phone Number: 704-904-6112

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants that Complete Walking Protocol with Real-time Device Assistance	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak external knee adduction moment	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	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.

Collaborators and Investigators

• Sponsor: Massachusetts Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: knee osteoarthritis; exoskeleton
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2505001645

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be available as it may contain identifying information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No