ClinicalTrials.gg
RecruitingNCT07652437Updated Jun 17, 2026

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

An interventional study of Dephy Exoboot in Knee Osteoarthristis, sponsored by Massachusetts Institute of Technology. Recruiting at 1 site in United States. Open to participants aged 21 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by Massachusetts Institute of Technology · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
21 Years to 100 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Knee Osteoarthristis

Keywords

  • knee osteoarthritis
  • exoskeleton
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 9 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Massachusetts Institute of Technology is the lead sponsor of 34 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (estimated)

Study 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.

    Device: Dephy Exoboot

Interventions

  • DeviceDephy 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 4 sessions across 4 weeks, each lasting up to 2 days.

Secondary outcomes

  1. Peak external knee adduction moment

    Quantitative analysis of knee adduction moment (N\*m / kg) between device and no device condition.

    Time frame: Up to 4 sessions across 4 weeks, each lasting up to 2 days.

  2. Change in self-selected walking speed

    Analysis of walking speed (m/s) changes between device and no device conditions

    Time frame: Up to 4 sessions across 4 weeks, each lasting up to 2 days.

07

Study locations

1 of 1 sites recruiting
  • MIT Media Lab
    Cambridge, Massachusetts 02139, United States
    Recruiting
    • Christopher Shallal, B.S. · Contact704-904-6112
08

References and documents

Individual participant data

Plan to share: No — IPD will not be available as it may contain identifying information.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Jul 2028, 30 months after the start.

Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 30 months is above that.

Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2026
First posted
Jun 17, 2026
StartActual
Dec 15, 2025
Primary completionEst.
Jul 1, 2028
CompletionEst.
Jul 1, 2029
Last update
Jun 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07652437
Lead sponsor
Massachusetts Institute of Technology
Responsible party
Christopher Shallal (Principal Investigator, Massachusetts Institute of Technology) — Principal investigator
First posted
Jun 17, 2026
Start date
Dec 15, 2025
Primary completion
Jul 1, 2028 (estimated)
Completion
Jul 1, 2029 (estimated)
Last update
Jun 17, 2026

Study contacts

Christopher Shallal, B.S.
Contact
cshallal@mit.edu
704-904-6112

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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