Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults - Study 1
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kim Kennedy
- Phone Number: 336.713.8567
- Email: kimberly.kennedy@advocatehealth.org
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Atrium Health Wake Forest Baptist
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: We Innovate Mobility (WIM)-Assisted Treadmill Walking
participants will complete one WIM-assisted treadmill-walking session |
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. |
|
Active Comparator: Conventional Treadmill Walking
participants will complete one conventional treadmill-walking session |
Participants will walk on the treadmill without assistance from the WIM device. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise Dose
Time Frame: Day 1
|
Exercise dose is defined as walking duration × average treadmill speed × average treadmill grade. |
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Perceived Exertion
Time Frame: Day 1
|
Rate of Perceived Exertion scale is 6-20 with the higher the number indicating a higher level of exertion. |
Day 1
|
|
Number of Participants that Ended Walking Session
Time Frame: Day 1
|
Number of participants that wanted to stop walking sessions due to symptoms such as shortness of breath, leg fatigue, dizziness, balance difficulties, pain, etc. |
Day 1
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WIM Walking Experience Survey
Time Frame: Day 1
|
We Innovate Mobility (WIM) Walking Experience survey has a total score range of 8-40 with higher score indicating a more comfortable experience with the device. |
Day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bumsoo Ahn, PhD, Atrium Health Wake Forest Baptist
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00157231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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