Mobility DisabilityNCT07859605
Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults - Study 2
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 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2028
- 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
- Able to provide informed consent and comply with study procedures
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
- 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
Kim Kennedy, 336-713-8567, kimberly.kennedy@advocatehealth.org
About this study
Official title: Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults
The purpose of this research 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 2 is an open-label, randomized, parallel-group controlled pilot trial. Participants will be randomized in a 1:1 ratio to eight weeks of supervised We Innovate Mobility (WIM)-assisted treadmill walking or conventional treadmill walking. Exercise intensity will be prescribed using a target of 70% heart rate reserve, with speed and grade adjusted to maintain walking intensity. Outcomes will be assessed before and after the intervention.
- 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 three times per week for eight weeks while wearing the device.
Conventional Treadmill WalkingOther
Participants will walk on the treadmill three times per week for eight weeks without assistance from the We Innovate Mobility (WIM) device.
| Study group | Role | What they receive |
|---|---|---|
| We Innovate Mobility (WIM)-Assisted Treadmill Walking | Experimental | participants will walk on treadmill with assistance from the We Innovate Mobility (WIM) device Receives: Device: We Innovate Mobility (WIM) Device |
| Conventional Treadmill Walking | Active comparator | participants will walk on treadmill without assistance from the We Innovate Mobility (WIM) device Receives: Other: Conventional Treadmill Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Oxygen Consumption
Change in peak oxygen consumption (VO2peak)
Measured: From baseline to week 8
Secondary outcomes (5)
Exercise Dose
Exercise dose is defined was walking duration x average treadmill speed x average treadmill grade
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
400 Meter Walk Time
Participants will be instructed to walk 400 meters at their usual fast pace without running, with standardized encouragement provided throughout the test. Participants will be permitted to slow down or rest briefly if needed for safety. Total completion time recorded. Participants will be permitted to slow down or rest briefly if needed for safety.
Measured: Baseline and Week 8
Expanded Short Physical Performance Battery (eSPPB)
eSPPB consists of 5 repeated chair stands, standing balance (semi- and full-tandem stands and a single leg stand for 30 seconds), a 6-meter walk to assess usual gait speed, and a narrow 6-meter walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). Total score range is 0-4 with a higher score indicating better performance.
Measured: Baseline and Week 8
PROMIS Fatigue Short Form 7a Survey
PROMIS Fatigue Short Form 7a measures the severity and functional impact of fatigue on everyday functioning. Total score range is 7-35 with a higher score indicating a higher level of fatigue.
Measured: Baseline and Week 8
Pittsburgh Fatigability Scale
Activity-related fatigability will be assessed using the Pittsburgh Fatigability Scale which evaluates perceived physical fatigue in response to standardized daily activities of defined intensity and duration. Total score range is 0-50 with higher numbers representing greater perceived fatigability.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT07859605
- Sponsor's protocol ID
- IRB00157231.2
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 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 6 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
- NCT07859605
- Acronym / sponsor ID
- IRB00157231.2
- Conditions
- Mobility Disability
- Keywords
- mobility decline, older adults, We Innovate Mobility (WIM) device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 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 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 2 is an open-label, randomized, parallel-group controlled pilot trial. Participants will be randomized in a 1:1 ratio to eight weeks of supervised We Innovate Mobility (WIM)-assisted treadmill walking or conventional treadmill walking. Exercise intensity will be prescribed using a target of 70% heart rate reserve, with speed and grade adjusted to maintain walking intensity. Outcomes will be assessed before and after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 walk on treadmill with assistance from the We Innovate Mobility (WIM) device |
| Conventional Treadmill Walking | Active comparator | Other: Conventional Treadmill Walkingparticipants will walk on treadmill without assistance from the We Innovate Mobility (WIM) device |
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
- Able to provide informed consent and comply with study procedures
Key exclusion criteria (5 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
- 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
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 three times per week for eight weeks while wearing the device. | Device | We Innovate Mobility (WIM)-Assisted Treadmill Walking |
| Conventional Treadmill WalkingParticipants will walk on the treadmill three times per week for eight weeks without assistance from the We Innovate Mobility (WIM) device. | Other | Conventional Treadmill Walking |
Primary outcome
Change in Peak Oxygen Consumption
Time frame: From baseline to week 8
Change in peak oxygen consumption (VO2peak)
5 secondary outcomes
Exercise Dose
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
400 Meter Walk Time
Time frame: Baseline and Week 8
Expanded Short Physical Performance Battery (eSPPB)
Time frame: Baseline and Week 8
PROMIS Fatigue Short Form 7a Survey
Time frame: Baseline and Week 8
Pittsburgh Fatigability Scale
Time frame: Baseline and Week 8
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 6 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 5 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 6 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?
Change in Peak Oxygen Consumption (time frame: From baseline to week 8). 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 6 Oct 2026.