Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Hip Joint Diseases

Recruiting now · Phase 4

Conditions studied: Hip Disease

In brief

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.

Key facts

Study ID

NCT07147530

Run by

Yonsei University

People needed

30

Starts

2025-04-07

Expected to finish

2026-04-06

Last updated by the study team

2025-08-29

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals aged 19 or older
• Individuals diagnosed with hip osteoarthritis of Kellgren-Lawrence (K-L) Grade 1-4
• Individuals diagnosed with avascular necrosis of the femoral head at Association Research Circulation Osseous(ARCO) Stage 1-4
• 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
• Individuals who have adequate cognitive ability (Korean Mini-Mental State Examination score ≥ 20)

You may not qualify if…

• 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
• 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

Where it is running

• Yongin Severance Hospital — Yongin-si, Gyeonggi-do, South Korea, South Korea (enrolling)

Full record on ClinicalTrials.gov

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