Exoskeleton Variability Optimization

Peripheral Arterial Disease Clinical Trial

Official title:

Exoskeleton Variability Optimization for Reducing Gait Variability for Patients With Peripheral Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04338815
• Other study ID #: 0376-19-FB
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: Philippe Malcolm, PhD
• Phone: 617-487-1148
• Email: pmalcolm[@]unomaha.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will evaluate a potentially faster and more clinically feasible method to optimize exoskeletons in pilot tests in healthy in preparation for patients with peripheral artery disease.

Description:

This study will test different methods for optimizing exoskeletons. It will consist of an habituation session to the hip exoskeleton, an optimization session to find the optimal actuation settings using an algorithm that converges toward the optimum based on real-time measurements (human-inthe-loop algorithm) and a post-test at the end of optimization session to compare different conditions. The outcomes will be evaluated by surface electromyography (Delsys), exoskeleton sensors (Futek), ground reaction force (Bertec treadmill), walking speed (Bertec treadmill), indirect calorimetry (Cosmed), and motion capture (Vicon).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

Inclusion Criteria:

• Ability to provide written consent
• Chronic claudication history
• Ankle-brachial index < 0.90 at rest
• Stable blood pressure, lipides, and diabetes for > 6 weeks
• Ability to walk on a treadmill for multiple five-minute spans.
• Ability to fit in exoskeleton: waist circumference 78 to 92 centimeters, thigh circumference 48 to 60 centimeters, minimal thigh length 28 centimeters.

Exclusion Criteria:

• Rest pain or tissue loss due to peripheral artery disease (Fontaine stage III and IV).
• Foot ulceration.
• Acute lower extremity event secondary to thromboembolic disease or acute trauma
• Walking capacity limited by diseases which are unrelated to peripheral artery disease such as: Neurological disorders, musculoskeletal disorders (arthritis, scoliosis, stroke, spinal injury, etc.), a history of ankle instability, knee injury, diagnosed joint laxity, lower limb injury, surgery within the past 12 months, joint replacement, pulmonary disease or breathing disorders, cardiovascular disease, or vestibular disorder. This will be determined by verbal questioning from research personnel by verbally asking about conditions limiting their walking, whether subjects are taking medications for those conditions, and physicians' recommendations about limiting activity.
• Acute injury or pain in their lower extremity or current illness.
• Inability to follow visual cues due to blindness.
• Inability to follow auditory cues due to deafness.
• Women who are currently pregnant are excluded for safety reasons.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Exoskeleton optimization
Participants will walk 10 times of 1 minute duration while an optimization algorithm changes the assistance profile of an exoskeleton.
• Endurance evaluation
Participants will walk 2 times at a speed of 1 meter per second until the participant indicates claudication or a maximum duration of 6 minutes.

Locations

Country	Name	City	State
United States	University of Nebraska Omaha	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to convergence	We will determine when the estimated optimal exoskeleton settings vary less than 10%	10 minutes
Primary	Peak extension timing	Timing of peak extension moment of exoskeleton (% stride cycle)	20 seconds
Primary	Peak flexion timing	Timing of peak flexion moment of exoskeleton (% stride cycle)	20 seconds
Primary	Largest lyapunov exponent	Largest lyapunov exponent of lower limb kinematics	20 seconds