Clinical Efficacy of Exoskeleton Assistance for Individuals Post-Stroke

Launched by GEORGIA INSTITUTE OF TECHNOLOGY · Sep 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a special robotic device called an exoskeleton can help people who have had a stroke to walk better. The exoskeleton is designed to support and assist movement, making it easier for stroke survivors to perform everyday activities. Researchers will test different types of exoskeletons to see which ones work best for improving walking patterns, both indoors and outdoors. The ultimate goal is to create personalized exoskeletons that can adjust to each person’s needs, helping them move more freely in their communities.

To be eligible for this trial, participants should be adults aged 18 to 85 who have had a stroke at least six months prior and are facing challenges with walking or movement. They should be able to sit up without help, walk a certain distance, and perform some basic movements on their own. During the trial, participants can expect to take part in sessions lasting between one to four hours, with breaks as needed, while they test the exoskeleton technology. It’s important to note that individuals with certain health issues, such as severe leg problems or other neurological conditions, will not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Chronic stroke survivors (at least 6 months post stroke)
• • Age 18-85 years of age with a neurological condition or gait impairment from stroke capable of participating in the study procedures (as per participant report)
• • Ability to sit unsupported for minimum of 30 seconds.
• • Ability to walk without support (a rail as needed), with a walking speed of at least 0.4 m/s (limited community ambulatory speed);
• • Must be able to walk for at least 6 minutes for each trial;
• • 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).
• Exclusion Criteria:
• • Any loss of sensation in the legs
• • A complete spinal cord injury,
• • History of concussion in the last 6 months (per participant report),
• • History of any severe cardiovascular conditions, severe arthritis, or orthopedic problems that limit lower body movement,
• • Presence of other neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia,
• • History of head trauma which is not fully resolved (per participant report),
• • Lower extremity amputation,
• • Non-healing ulcers of a lower extremity,
• • Renal dialysis or end state liver disease,
• • Legal blindness or severe visual impairment.
• • Use of a pacemaker or
• • Presence of metal implants in the head region,
• • Have uncontrolled seizures.
• • Lastly, if participants are participating in another clinical study and/or a participant's physical condition is limited to do different tasks, in the opinion of the Principal Investigator (PI), would likely affect the study outcome or confound the results, participants will be excluded from the study.