Status:
RECRUITING
Effectiveness and Safety of At-home Gait Rehabilitation Using Wearable Exoskeletal Robot
Lead Sponsor:
Yonsei University
Conditions:
Stroke
Gait, Spastic
Eligibility:
All Genders
19-79 years
Phase:
PHASE4
Brief Summary
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 ma...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- adults aged 19 to 79 years (based on the age on their national ID at the time of consent)
- individuals diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by MRI or CT.
- patients who have passed at least one month since stroke diagnosis.
- individuals exhibiting spastic hemiplegic gait patterns due to stroke.
- patients with a Functional Ambulatory Category score of less than 4.
- individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without assistance.
- individuals with sufficient cognitive ability to follow simple instructions and understand the study's content and purpose (Mini-Mental State Examination score \>= 20)
Exclusion
- individuals with severe joint contractures or osteoporosis, or untreated fractures that contraindicate weight-bearing on the lower limbs.
- individuals with skin conditions or open wounds that prevent device usage.
- individuals with significant differences in leg length.
- individuals with severe deformities or joint contractures in the lower limbs.
- individuals at high risk of fractures due to conditions like osteoporosis.
- individuals unable to maintain a sitting or standing position independently.
- individuals with severe lower limb spasticity (Modified Ashworth Scale grade 2 or higher).
- 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.
- individuals unable to maintain prolonged standing or walking due to conditions like orthostatic hypotension or cardiopulmonary impairment.
- individuals with conditions affecting gait, such as peripheral neuropathy, Parkinsonism, or those with alcohol dependence or severe diabetes.
- pregnant women or those who could become pregnant.
- individuals participating in other clinical trials.
- individuals at high risk of falls or bleeding due to conditions like coagulopathies.
- individuals shorter than 140 cm, taller than 190 cm, or weighing over 80 kg.
- individuals with other clinical findings deemed inappropriate for the study by the principal investigator or study coordinator.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06543758
Start Date
August 1 2024
End Date
July 31 2026
Last Update
November 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea, 16995