Mobility DisabilityNCT07857902
Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults - Study 1
A study testing We Innovate Mobility (WIM) Device and Conventional Treadmill Walking in people with Mobility Disability, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to learn whether a lightweight wearable robotic device called We Innovate Mobility (WIM) can improve exercise capacity and physical function for older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mobility Disability
- What is being tested?
- We Innovate Mobility (WIM) Device and Conventional Treadmill Walking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2027
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Community-dwelling adult aged ≥65 years
- Able to safely wear and use the WIM device
- Willing to complete conventional and WIM-assisted treadmill walking
- Able to provide informed consent and comply with study procedures
- Usual gait speed of 0.6-0.8 m/s
Who cannot join
- Recent hospitalization, surgery, fracture, or other medical condition that limits safe treadmill walking
- Resting blood pressure, heart rate, or symptoms that meet protocol-defined safety exclusion criteria before exercise
- Willing to complete conventional and WIM-assisted treadmill walking
- Requires a cane, walker, or other assistive device for ambulation
- Regular participation in structured aerobic exercise
- Any condition judged by the study clinician to make participation unsafe or interfere with study procedures
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
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults
The purpose of this research study is to learn whether a lightweight wearable robotic device called We Innovate Mobility (WIM) can improve exercise capacity and physical function for older adults.
Read the detailed description
Study 1 is a randomized, controlled, two-period crossover trial. The study evaluates We Innovate Mobility (WIM)-assisted treadmill walking in community-dwelling adults aged ≥65 years who are at risk for mobility disability. WIM is an externally worn, powered device that provides temporary mechanical assistance during voluntary walking. The WIM device will be set to Air mode at Assistance Level 1 to standardize the degree of robotic assistance across participants and sessions while allowing exercise dose to be manipulated through treadmill speed, grade, and duration.
- Conditions
- Mobility Disability
- Being tested
- We Innovate Mobility (WIM) Device, Conventional Treadmill Walking
- Keywords
- mobility decline, older adults, We Innovate Mobility (WIM) device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
We Innovate Mobility (WIM) DeviceDevice
We Innovate Mobility (WIM) is an externally worn, powered device that provides temporary mechanical assistance during voluntary walking. Participants will walk on the treadmill while wearing the device.
Conventional Treadmill WalkingOther
Participants will walk on the treadmill without assistance from the WIM device.
| Study group | Role | What they receive |
|---|---|---|
| We Innovate Mobility (WIM)-Assisted Treadmill Walking | Experimental | participants will complete one WIM-assisted treadmill-walking session Receives: Device: We Innovate Mobility (WIM) Device |
| Conventional Treadmill Walking | Active comparator | participants will complete one conventional treadmill-walking session Receives: Other: Conventional Treadmill Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Dose
Exercise dose is defined as walking duration × average treadmill speed × average treadmill grade.
Measured: Day 1
Secondary outcomes (2)
Rate of Perceived Exertion
Rate of Perceived Exertion scale is 6-20 with the higher the number indicating a higher level of exertion.
Measured: Day 1
Number of Participants that Ended Walking Session
Number of participants that wanted to stop walking sessions due to symptoms such as shortness of breath, leg fatigue, dizziness, balance difficulties, pain, etc.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility DisabilityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bumsoo Ahn, PhD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857902
- Sponsor's protocol ID
- IRB00157231
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults
- ClinicalTrials.gov ID
- NCT07857902
- Acronym / sponsor ID
- IRB00157231
- Conditions
- Mobility Disability
- Keywords
- mobility decline, older adults, We Innovate Mobility (WIM) device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Oct 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.
The purpose of this research study is to learn whether a lightweight wearable robotic device called We Innovate Mobility (WIM) can improve exercise capacity and physical function for older adults.
Detailed description
Study 1 is a randomized, controlled, two-period crossover trial. The study evaluates We Innovate Mobility (WIM)-assisted treadmill walking in community-dwelling adults aged ≥65 years who are at risk for mobility disability. WIM is an externally worn, powered device that provides temporary mechanical assistance during voluntary walking. The WIM device will be set to Air mode at Assistance Level 1 to standardize the degree of robotic assistance across participants and sessions while allowing exercise dose to be manipulated through treadmill speed, grade, and duration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| We Innovate Mobility (WIM)-Assisted Treadmill Walking | Experimental | Device: We Innovate Mobility (WIM) Deviceparticipants will complete one WIM-assisted treadmill-walking session |
| Conventional Treadmill Walking | Active comparator | Other: Conventional Treadmill Walkingparticipants will complete one conventional treadmill-walking session |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Community-dwelling adult aged ≥65 years
- Able to safely wear and use the WIM device
- Willing to complete conventional and WIM-assisted treadmill walking
- Able to provide informed consent and comply with study procedures
- Usual gait speed of 0.6-0.8 m/s
Key exclusion criteria (6 listed)
- Recent hospitalization, surgery, fracture, or other medical condition that limits safe treadmill walking
- Resting blood pressure, heart rate, or symptoms that meet protocol-defined safety exclusion criteria before exercise
- Willing to complete conventional and WIM-assisted treadmill walking
- Requires a cane, walker, or other assistive device for ambulation
- Regular participation in structured aerobic exercise
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 |
|---|---|---|
| We Innovate Mobility (WIM) DeviceWe Innovate Mobility (WIM) is an externally worn, powered device that provides temporary mechanical assistance during voluntary walking. Participants will walk on the treadmill while wearing the device. | Device | We Innovate Mobility (WIM)-Assisted Treadmill Walking |
| Conventional Treadmill WalkingParticipants will walk on the treadmill without assistance from the WIM device. | Other | Conventional Treadmill Walking |
Primary outcome
Exercise Dose
Time frame: Day 1
Exercise dose is defined as walking duration × average treadmill speed × average treadmill grade.
2 secondary outcomes
Rate of Perceived Exertion
Time frame: Day 1
Number of Participants that Ended Walking Session
Time frame: Day 1
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Bumsoo Ahn, PhD principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing We Innovate Mobility (WIM) Device and Conventional Treadmill Walking in people with Mobility Disability, run by Wake Forest University Health Sciences 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 5 Oct 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 Kim Kennedy (336.713.8567, kimberly.kennedy@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Dose (time frame: Day 1). 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 5 Oct 2026.