Knee OsteoarthristisNCT07652437
Study of Wearable Interventions for Improving Mobility of Individuals With Knee Osteoarthritis
A study testing Dephy Exoboot in people with Knee Osteoarthristis, run by Massachusetts Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Dephy Exoboot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MIT Media Lab
Cambridge, Massachusetts, 02139
Christopher Shallal, B.S., 704-904-6112
About this study
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.
- Conditions
- Knee Osteoarthristis
- Being tested
- Dephy Exoboot
- Keywords
- knee osteoarthritis, exoskeleton
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dephy ExobootDevice
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 group | Role | What they receive |
|---|---|---|
| Wearable Intervention for Individuals with Knee Osteoarthritis | Experimental | 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. Receives: Device: Dephy Exoboot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 sessions across 4 weeks, each lasting up to 2 days.
Secondary outcomes (2)
Peak external knee adduction moment
Quantitative analysis of knee adduction moment (N*m / kg) between device and no device condition.
Measured: 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
Measured: Up to 4 sessions across 4 weeks, each lasting up to 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start15 Dec 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Shallal, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652437
- Sponsor's protocol ID
- 2505001645
- Status last verified
- Jun 2026
- First submitted
- 27 Feb 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be available as it may contain identifying information.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Wearable Interventions for Improving Mobility of Individuals With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07652437
- Acronym / sponsor ID
- 2505001645
- Conditions
- Knee Osteoarthristis
- Keywords
- knee osteoarthritis, exoskeleton
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable Intervention for Individuals with Knee Osteoarthritis | Experimental | Device: Dephy ExobootParticipants 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dephy ExobootIndividuals 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 | Device | Wearable Intervention for Individuals with Knee Osteoarthritis |
Primary outcome
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.
2 secondary outcomes
Peak external knee adduction moment
Time frame: Up to 4 sessions across 4 weeks, each lasting up to 2 days.
Change in self-selected walking speed
Time frame: Up to 4 sessions across 4 weeks, each lasting up to 2 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. IPD will not be available as it may contain identifying information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dephy Exoboot in people with Knee Osteoarthristis, run by Massachusetts Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Shallal, B.S. (704-904-6112, cshallal@mit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.