NCT07147530 Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Hip Joint Diseases
| NCT ID | NCT07147530 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Yonsei University |
| Condition | Hip Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2026-04-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2025-04-07 with a primary completion date of 2026-04-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 quality of life, increase the risk of falls, decrease the ability to perform daily activities, and limit physical activity. Various musculoskeletal diseases can cause gait impairment, with hip osteoarthritis and osteonecrosis of the femoral head (ONFH) being the most representative conditions. Various interventions can be attempted during the early stages of hip joint disease progression. However, improvement in symptoms does not necessarily indicate a halt in disease progression. As the condition advances in most patients, thinning of the full-thickness hip cartilage or collapse of the femoral head occurs, leading to restricted hip range of motion, weakness of the lower limb muscles and functional deterioration, resulting in the need for total hip arthroplasty. THA offers significant improvements in pain relief and function, regardless of the patient's preoperative status, and can reduce long-term healthcare costs. However, performing THA at an early stage with minimal functional improvement is not recommended. Postoperative complications, such as infections, aseptic loosening, and instability, are potential risks, with younger patients aged 45-64 showing higher revision surgery rates compared to those aged 65 and older. This highlights the need for new interventions that can delay the time to surgery while improving gait function and muscle strength. Therefore, this study aims to explore the clinical feasibility of the Angel Suit H10 (Angelrobotics, Seoul, Korea) by assessing whether wearing the Electrically Powered Orthopedic Exercise Device improves gait function in patients with hip joint diseases, along with evaluating user satisfaction and device safety.
Eligibility Criteria
Inclusion Criteria: 1. Individuals aged 19 or older 2. Individuals diagnosed with hip osteoarthritis of Kellgren-Lawrence (K-L) Grade 1-4 3. Individuals diagnosed with avascular necrosis of the femoral head at Association Research Circulation Osseous(ARCO) Stage 1-4 4. Individuals able to sit at the edge of a bed without assistance and stand for 10 seconds regardless of support 5. Individuals who are Functional Ambulatory Category (FAC) score of 1-3 6. Individuals who visited Yongin Severance Hospital, understood the study, and signed informed consent 7. Individuals who have adequate cognitive ability (Korean Mini-Mental State Examination score ≥ 20) Exclusion Criteria: 1. Individuals who have contraindications for lower limb weight-bearing such as severe joint contractures, osteoporosis, or untreated fractures 2. Individuals who have progressive or unstable brain diseases or neurological paralysis from stroke 3. Individuals who have active infections or open wounds hindering device use 4. Individuals who have significant leg length discrepancies 5. Individuals who have severe deformities or contractures in the lower extremities 6. Individuals who have history of poliomyelitis 7. Individuals inable to maintain seated or standing positions independently 8. Individuals who have severe spasticity (Modified Ashworth Scale grade ≥ 2) 9. Individuals who have bone metastases from cancer 10. Individuals who have severe internal diseases affecting device use (e.g., cardiovascular or respiratory diseases) 11. Individuals who have cognitive impairments preventing cooperation with device use 12. Individuals who have complaints of device-related side effects or potential rehabilitation discontinuation 13. Patients who are determined to be pregnant or potentially pregnant based on the medical interview 14. Individuals who have any other clinically significant findings deemed inappropriate by the investigator
Contact & Investigator
Na Young Kim, MD, PhD
PRINCIPAL INVESTIGATOR
Severance Hospital
Frequently Asked Questions
Who can join the NCT07147530 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Hip Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07147530 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07147530 currently recruiting?
Yes, NCT07147530 is actively recruiting participants. Contact the research team at kny8452@yuhs.ac for enrollment information.
Where is the NCT07147530 trial being conducted?
This trial is being conducted at Yongin-si, South Korea.
Who is sponsoring the NCT07147530 clinical trial?
NCT07147530 is sponsored by Yonsei University. The principal investigator is Na Young Kim, MD, PhD at Severance Hospital. The trial plans to enroll 30 participants.