Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults - Study 1

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • We Innovate Mobility (WIM) Device

    Device

    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 Walking

    Other intervention

    Participants will walk on the treadmill without assistance from the WIM device.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: We Innovate Mobility (WIM)-Assisted Treadmill WalkingExperimental treatment 1 intervention
Group B: Conventional Treadmill WalkingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Exercise Dose

Exercise dose is defined as walking duration × average treadmill speed × average treadmill grade.

Time frame
Day 1

Secondary outcomes

1

Rate of Perceived Exertion

Rate of Perceived Exertion scale is 6-20 with the higher the number indicating a higher level of exertion.

Time frame
Day 1
2

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.

Time frame
Day 1

Other outcomes

1

WIM Walking Experience Survey

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.

Time frame
Day 1

Sponsors and contacts

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