Actively Recruiting

Phase 4
Age: 19Years +
All Genders
NCT07147491

Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Who Have Undergone Hip Surgery

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. Gait disorders can result from various musculoskeletal conditions, with hip osteoarthritis, avascular necrosis of the femoral head, and hip fractures being the most representative causes. In the early stages of hip osteoarthritis, avascular necrosis of the femoral head, or non-severely displaced hip fractures, various intervention therapies, including rehabilitation exercise therapy and injection treatments, can be attempted. However, these intervention therapies only alleviate symptoms and cannot prevent disease progression. Consequently, most patients eventually experience thinning of the full-thickness hip cartilage, collapse of the femoral head, nonunion, or worsening displacement, which leads to restricted hip range of motion. As a result, lower limb muscle weakness and functional decline occur, ultimately requiring hip surgeries such as total hip arthroplasty or open reduction and internal fixation. Although most patients experience a recovery in gait ability after hip surgery, some show a slower recovery rate or fail to achieve normal walking. It has been reported that over 80% of function is recovered by three months after surgery; however, during this period, patients experience limitations in performing daily activities. As a compensatory mechanism, excessive weight-bearing on the non-operated limb may occur, increasing the risk of overloading the non-operated hip. This may lead to the development of osteoarthritis in the non-operated limb and has also been reported to increase the risk of falls. Therefore, various methods are being studied to facilitate gait function recovery after hip surgery and promote an early return to daily activities. 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 who have undergone hip surgery, 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 Who Have Undergone Hip Surgery

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 medically stable
  • Individuals with adequate cognitive ability (Korean Mini-Mental State Examination score 20 or higher)
  • Individuals able to sit at the edge of a bed without assistance and stand for 10 seconds regardless of support
  • Individuals with a Functional Ambulatory Category (FAC) score of 1 to 3
  • Individuals who visited Yongin Severance Hospital, understood the study, and signed informed consent
Not Eligible

You will not qualify if you...

  • Individuals with exudate or symptoms like heat, redness, swelling, or severe pain at the surgical site after hip surgery
  • Individuals with contraindications for lower limb weight-bearing such as severe joint contractures, osteoporosis, or untreated fractures
  • Individuals with progressive or unstable brain diseases or neurological paralysis from stroke
  • Individuals with active infections or open wounds preventing device use
  • Individuals with significant leg length differences
  • Individuals with severe deformities or contractures in the lower limbs
  • Individuals with a history of poliomyelitis
  • Individuals unable to maintain seated or standing positions independently
  • Individuals with severe spasticity (Modified Ashworth Scale grade 2 or higher)
  • Individuals with bone metastases from cancer
  • Individuals with severe internal diseases affecting device use (such as cardiovascular or respiratory diseases)
  • Individuals with cognitive impairments preventing cooperation with device use
  • Individuals with complaints of device-related side effects or potential rehabilitation discontinuation (e.g., severe obesity, skeletal deformity)
  • Patients determined to be pregnant or potentially pregnant
  • Individuals with any other clinically significant findings deemed inappropriate by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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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