Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07652437

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MIT Media Lab

Cambridge, Massachusetts, 02139, United States

Location status: Recruiting

Location contact

Christopher Shallal, B.S.

CONTACT

704-904-6112

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

    Number of participants that complete the walking protocol with device providing assistance without device-related restrictions.

Secondary outcomes

  1. Peak external knee adduction moment

    Time frame: 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.

  2. Change in self-selected walking speed

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Shallal, B.S.

CONTACT

[email protected]

704-904-6112

Sponsors and collaborators

Lead sponsor

Massachusetts Institute of Technology

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.