Actively Recruiting

Phase 4
Age: 19Years +
All Genders
NCT07147530

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

Led by Yonsei University · Updated on 2025-08-29

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 19 years or older
  • Diagnosed with hip osteoarthritis of Kellgren-Lawrence Grade 1 to 4
  • Diagnosed with avascular necrosis of the femoral head at Association Research Circulation Osseous Stage 1 to 4
  • Able to sit at the edge of a bed without help and stand for 10 seconds with or without support
  • Functional Ambulatory Category score of 1 to 3
  • Visited Yongin Severance Hospital, understood the study, and signed informed consent
  • Have adequate cognitive ability with Korean Mini-Mental State Examination score of 20 or higher
Not Eligible

You will not qualify if you...

  • Have contraindications for lower limb weight-bearing such as severe joint contractures, osteoporosis, or untreated fractures
  • Have progressive or unstable brain diseases or neurological paralysis from stroke
  • Have active infections or open wounds that prevent device use
  • Have significant leg length differences
  • Have severe deformities or contractures in the lower limbs
  • Have a history of poliomyelitis
  • Unable to sit or stand independently
  • Have severe spasticity with Modified Ashworth Scale grade 2 or higher
  • Have bone metastases from cancer
  • Have severe internal diseases affecting device use, such as heart or lung diseases
  • Have cognitive impairments preventing cooperation with device use
  • Have complaints of device-related side effects or may discontinue rehabilitation
  • Are pregnant or possibly pregnant
  • Have other significant clinical findings deemed inappropriate by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Yongin Severance Hospital

Yongin-si, Gyeonggi-do, South Korea, South Korea, 16995

Actively Recruiting

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Research Team

N

Na Young Kim, MD, PhD

CONTACT

H

Hwi Woo Yang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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