Exoskeleton for Balance After Stroke

Overseen By Jesse C. Dean, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Hypertension, Cardiac arrhythmias, Neurological disorders, Visual impairment, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 year

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Many people who have experienced a stroke have deficits in their walking balance. The long-term goal of this research is to develop an exoskeleton that can effectively improve walking balance, thus improving functional mobility.

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke and are experiencing difficulties with walking balance. Specific eligibility criteria to join the study or reasons for exclusion were not provided.

Inclusion Criteria

I am at least 21 years old.

I can walk at a speed of at least 0.2 meters per second.

I can follow instructions and communicate about my balance.

Exclusion Criteria

Presence of neglect

I have a history of serious heart conditions.

Resting blood pressure higher than 220/110 mm Hg

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will walk on a treadmill under several exoskeleton assistance conditions, including no exoskeleton, and varying impedance levels (zero, low, medium, high).

1 year

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exoskeleton (high impedance)
• Exoskeleton (low impedance)
• Exoskeleton (medium impedance)
• Exoskeleton (zero impedance)

Trial Overview

The study is testing different versions of an exoskeleton designed to help with walking balance after a stroke. Participants will be compared using no exoskeleton, or one set at low, zero, medium, or high impedance levels.

How Is the Trial Designed?

Group I: xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance) Experimental Treatment 5 Interventions

Participants in this arm will walk on a treadmill under several conditions. In one condition, they will not wear the exoskeleton. In other conditions, the exoskeleton will be set to zero, low, medium, or high impedance.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+