Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot

Launched by YONSEI UNIVERSITY · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help stroke patients improve their walking abilities using a wearable robotic device called an exoskeletal robot. The goal is to see if using this robot at home can make it easier and faster for patients to walk, as well as improve their balance and overall satisfaction with the training. Participants will wear the robot during 10 sessions of 30-minute gait training over four weeks. They will also take part in physical tests to measure their walking speed and balance before and after the training, and they will fill out surveys about their quality of life and feelings of depression.

To be eligible for this trial, participants need to be adults between the ages of 19 and 79, have had a stroke diagnosed through medical imaging, and show specific walking difficulties. They should be able to sit and stand with or without help and understand simple instructions. However, those with certain medical conditions or significant mobility issues will not be included. If you decide to participate, you’ll be using this innovative technology in a supportive environment, and your progress will be closely monitored to ensure your safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. adults aged 19 to 79 years (based on the age on their national ID at the time of consent)
• • 2. individuals diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by MRI or CT.
• • 3. patients who have passed at least one month since stroke diagnosis.
• • 4. individuals exhibiting spastic hemiplegic gait patterns due to stroke.
• • 5. patients with a Functional Ambulatory Category score of less than 4.
• • 6. individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without assistance.
• • 7. individuals with sufficient cognitive ability to follow simple instructions and understand the study's content and purpose (Mini-Mental State Examination score \>= 20)
• Exclusion Criteria:
• • 1. individuals with severe joint contractures or osteoporosis, or untreated fractures that contraindicate weight-bearing on the lower limbs.
• • 2. individuals with skin conditions or open wounds that prevent device usage.
• • 3. individuals with significant differences in leg length.
• • 4. individuals with severe deformities or joint contractures in the lower limbs.
• • 5. individuals at high risk of fractures due to conditions like osteoporosis.
• • 6. individuals unable to maintain a sitting or standing position independently.
• • 7. individuals with severe lower limb spasticity (Modified Ashworth Scale grade 2 or higher).
• • 8. individuals with severe cognitive impairment (Mini-Mental State Examination score \< 20), delirium, or severe language impairment that hinders cooperation with wearable exoskeletal robot gait training.
• • 9. individuals unable to maintain prolonged standing or walking due to conditions like orthostatic hypotension or cardiopulmonary impairment.
• • 10. individuals with conditions affecting gait, such as peripheral neuropathy, Parkinsonism, or those with alcohol dependence or severe diabetes.
• • 11. pregnant women or those who could become pregnant.
• • 12. individuals participating in other clinical trials.
• • 13. individuals at high risk of falls or bleeding due to conditions like coagulopathies.
• • 14. individuals shorter than 140 cm, taller than 190 cm, or weighing over 80 kg.
• • 15. individuals with other clinical findings deemed inappropriate for the study by the principal investigator or study coordinator.