Assistive Hip Exoskeleton Study for Stroke

Completed · Not applicable

Conditions studied: Lower Limb Injury, Stroke

In brief

The increased metabolic and biomechanical demands of ambulation limit community mobility in persons with lower limb disability due to neurological damage. There is a critical need for improving the locomotion capabilities of individuals with stroke to increase their community mobility, independence, and health. Robotic exoskeletons have the potential to assist these individuals by increasing community mobility to improve quality of life. While these devices have incredible potential, current technology does not support dynamic movements common with locomotion such as transitioning between different gaits and supporting a wide variety of walking speeds. One significant challenge in achieving community ambulation with exoskeletons is providing an adaptive control system to accomplish a wide variety of locomotor tasks. Many exoskeletons today are developed without a detailed understanding of the effect of the device on the human musculoskeletal system. This research is interested in studying the question of how the control system affects stroke biomechanics including kinematic, kinetics and muscle activation patterns. By optimizing exoskeleton controllers based on human biomechanics and adapting control based on task, the biggest benefit to patient populations will be achieved to help advance the state-of-the-art with assistive hip exoskeletons.

Key facts

Study ID

NCT03924765

Run by

Georgia Institute of Technology

People needed

10

Starts

2019-07-24

Expected to finish

2020-11-19

Last updated by the study team

2021-12-15

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18-85 years
• Had stroke over 6 months prior
• Greater than 17 on minimental state examination (MMSE)
• Sit unsupported for a minimum of 30 seconds
• Follow a 3 step command.
• Ability to walk without support (a rail as needed is allowed), with a walking speed of at least 0.4 m/s (limited community ambulatory speed)
• Ability to walk for at least 6 minutes
• Willingness and ability to participate over a 1-4 hour experiment, with breaks enforced regularly and as needed
• Ability to transfer (sit-to-stand and stand-to-sit) with no external support (arm rests support allowed)
• Ability to ambulate over small slopes (3 degrees) and a few steps (6 steps)

You may not qualify if…

• Loss of sensation in the legs
• A complete spinal cord injury
• History of concussion in the last 6 months
• History of any severe cardiovascular conditions
• Severe arthritis
• Orthopedic problems that limit lower extremity passive range of motion (knee flexion contracture of >10 degrees, knee flexion active ROM 15 degrees)
• Pre-existing neurological and other disorders such as Parkinson's disease, ALS, MS, dementia
• History of head trauma
• Lower extremity amputation
• Non-healing ulcers of a lower extremity
• Renal dialysis or end state liver disease
• Legal blindness or severe visual impairment
• Uses a pacemaker
• Has a metal implants in the head region
• Uses medications that lower seizure thresholds.
• Lastly, if the subject is participating in another clinical trial and/or subject's condition relating to criteria that, in the opinion of the Principal Investigator (PI), would likely affect the study outcome or confound the results, subject will be excluded from the study.

Where it is running

• Exoskeleton and Prosthetic Intelligent Controls Lab — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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