Status:
RECRUITING
Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Who Have Undergone Hip Surgery
Lead Sponsor:
Yonsei University
Conditions:
Hip Surgery
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
Gait is an essential daily activity performed through the complex coordination of the central and peripheral nervous systems and the musculoskeletal system. Gait disorders can negatively affect qualit...
Detailed Description
(1) Overview of study design This investigator-initiated exploratory study is a pilot study designed to evaluate the effectiveness and safety of the Electrically Powered Orthopedic Exercise Device by ...
Eligibility Criteria
Inclusion
- Individuals aged 19 or older
- Individuals who have undergone hip surgery due to hip osteoarthritis, avascular necrosis of the femoral head, or hip fracture
- Individuals who are at least two days post-hip surgery and are assessed to be medically stable
- Individuals who have adequate cognitive ability (Korean Mini-Mental State Examination score ≥ 20)
- Individuals able to sit at the edge of a bed without assistance and stand for 10 seconds regardless of support
- Individuals who are Functional Ambulatory Category (FAC) score of 1-3
- Individuals who visited Yongin Severance Hospital, understood the study, and signed informed consent
Exclusion
- Individuals who, after undergoing hip surgery, present with exudate at the surgical site or report symptoms such as heat, redness, swelling, or severe pain at the affected area
- Individuals who have contraindications for lower limb weight-bearing such as severe joint contractures, osteoporosis, or untreated fractures
- Individuals who have progressive or unstable brain diseases or neurological paralysis from stroke
- Individuals who have active infections or open wounds hindering device use
- Individuals who have significant leg length discrepancies
- Individuals who have severe deformities or contractures in the lower extremities
- Individuals who have history of poliomyelitis
- Individuals inable to maintain seated or standing positions independently
- Individuals who have severe spasticity (Modified Ashworth Scale grade ≥ 2)
- Individuals who have bone metastases from cancer
- Individuals who have severe internal diseases affecting device use (e.g., cardiovascular or respiratory diseases)
- Individuals who have cognitive impairments preventing cooperation with device use
- Individuals who have complaints of device-related side effects or potential rehabilitation discontinuation (e.g., severe obesity, skeletal deformity)
- Patients who are determined to be pregnant or potentially pregnant based on the medical interview
- Individuals who have any other clinically significant findings deemed inappropriate by the investigator
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 6 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07147491
Start Date
April 7 2025
End Date
April 6 2026
Last Update
August 29 2025
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, South Korea, 16995