Status:
COMPLETED
Research on Clinical Safety and Effectiveness of Wearable Assistive Devices With Flexible Structure for Daily Life Support of Stroke Patients
Lead Sponsor:
Yonsei University
Conditions:
Stroke
Hemiplegia
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
Gait independence is a critical goal for stroke patients and significantly impacts their return to society. Due to hemiplegia, stroke patients often face walking difficulties. Compensatory approaches ...
Detailed Description
The study will enroll 20 participants, providing knee and hip assistance during overground walking adaptation training. Participants will undergo an initial assessment followed by three 30-minute sess...
Eligibility Criteria
Inclusion
- 1\. Adult patients aged 19 years and older 2. Diagnosed with stroke confirmed by neurologists or neurosurgeons through imaging techniques such as CT or MRI 3. Chronic hemiplegic stroke patients, 6 months or more post-stroke onset 4. Patients with a Functional Ambulatory Category (FAC) score of 3 or higher 5. Patients with a Mini-Mental State Examination (MMSE) score of 10 or higher, who can understand the study, have a voluntary willingness to participate, and have given consent to participate
Exclusion
- 1\. Acute/subacute stroke patients within 6 months of stroke onset 2. Quadriplegia 3. Ataxia 4. Severe lower limb joint contractures that make wearing the assistive device difficult 5. Patients with neurological, musculoskeletal, or cardiopulmonary diseases that affect walking 6. Any other conditions deemed inappropriate for participation in the study by the researcher
Key Trial Info
Start Date :
May 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06549127
Start Date
May 15 2023
End Date
May 29 2024
Last Update
August 12 2024
Active Locations (1)
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1
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
Seoul, South Korea