Exoskeleton for Balance

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Stroke

Treatments: Device: No Exoskeleton; Device: Exoskeleton (low impedance); Device: Exoskeleton (zero impedance); Device: Exoskeleton (medium impedance); Device: Exoskeleton (high impedance)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07356011

Pro00135871

REGE22000170 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Walking balance is an important component of functional mobility, with post-stroke balance deficits contributing to a fall rate more than double that of age-matched controls. Unfortunately, traditional therapy approaches have not succeeded in addressing balance deficits or reducing fall risk, motivating the use of technology to fill this gap. Although assistive exoskeletons are a promising approach to improve post-stroke mobility, they have generally not been designed to control walking balance and agility. This limitation is a particular concern in the development of devices for people with stroke, as applying forces to "assist" some aspect of walking (including balance) can have unexpected negative effects. The project goal is to investigate the potential of exoskeleton assistance to improve walking balance that will be accepted by people with stroke. To this end, investigators will use a previously developed hip exoskeleton to quantify the effects of assisting gait stabilization.

Enrollment: 21 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Evidence of a stroke at least 6 months prior to participation
• Evidence of dysfunction of the paretic lower limb (Fugl-Meyer lower extremity motor score < 34)
• At least 21 years of age
• Self-reported experience of a fall in the previous year, and/or a fear of falling
• Gait speed of at least 0.2 m/s
• Ability to walk on a treadmill without a cane or walker
• Ability to follow three step commands and communicate with experimenters to answer questions (e.g., regarding their balance confidence)
• Provision of informed consent

Exclusion criteria

• Resting blood pressure higher than 220/110 mm Hg
• History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
• Preexisting neurological orders or dementia
• Legal blindness or severe visual impairment
• Presence of neglect
• History of DVT or pulmonary embolism within 6 months
• Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
• Orthopedic injuries or conditions (e.g., joint replacements) in the lower extremities with the potential to alter the gait pattern

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)

Experimental group

Description:

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.

Treatment:

Device: Exoskeleton (high impedance)

Device: Exoskeleton (medium impedance)

Device: Exoskeleton (zero impedance)

Device: Exoskeleton (low impedance)

Device: No Exoskeleton