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

Study to Verify Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot to Improve Gait in Stroke Patients, Investigator Initiated, Single Center, Single Group Trial

The goal of this clinical trial is to evaluate the effectiveness and safety of a home-based robotic-assisted gait rehabilitation service using a wearable exoskeletal robot for stroke patients.

The main questions it aims to answer are:

• Can home-based robotic-assisted gait training improve walking speed in stroke patients?
• Does this intervention enhance body composition, gait patterns, balance in participants?
• How satisfied are participants with the use of the wearable exoskeletal robot ?

Researchers will compare pre- and post-intervention walking speeds, body composition, spatiotemporal parameters, balance, and satisfaction survey and does not establish a control group.

Participants will:

• Wear a wearable exoskeletal robot for gait training.
• Undergo 10 sessions of 30-minute gait training over 4 weeks at home or in nearby indoor spaces.
• Participate in physical function assessments including the 10-meter walk test, Timed Up and Go (TUG) test, and Berg Balance Scale before and after the intervention.
• Complete quality of life and depression inventories before and after the intervention.

After obtaining informed consent, a screening test is conducted. The screening test includes a review of the participant's baseline symptoms and signs, medical history, and medication usage, followed by a physical examination and assessment of gait status, including the use of assistive devices and gait patterns. Participants who pass the screening test undergo an initial assessment within seven days.

The initial assessment includes physical function tests such as the 10-meter walk test, the Timed Up and Go (TUG) test, and the Berg Balance Scale, along with quality of life and Beck Depression Inventory assessments. Participants who complete the initial assessment begin robotic-assisted gait training within two days.

The training is conducted using a wearable exoskeletal robot for gait training at home or in nearby indoor spaces. The training lasts for four weeks, with sessions held 2-3 times per week, totaling 10 sessions, each lasting 30 minutes.

After four weeks, the robotic-assisted gait training concludes, and within two days, an endpoint assessment identical to the initial assessment is performed. Satisfaction with the wearable exoskeletal robot is also evaluated.

Any device malfunctions are addressed and documented. The usage and satisfaction levels of the wearable exoskeletal robot are analyzed, and pre- and post-training assessment metrics are compared.

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.