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

NCT07147530 | Recruiting Phase 4

• 1 other identifier: 9-2025-0018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Disease

Keywords

Rehabilitation; Gait; Wearable robot; Hip joint disease

Outcome Measures

Primary Outcomes (1)

• 10-Meter Walk Test

  Patients are instructed to walk 14 m, including 2 m at both ends for acceleration and deceleration, at their comfortable speed. Gait speed was calculated by dividing the 10m distance by the time taken.

  A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4

Secondary Outcomes (9)

• Timed Up and Go (TUG) Test

  A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4

• 6-Minute Walk Test

  A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4

• Berg balance scale (BBS)

  A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4

• Spatiotemporal Parameters of Gait : Total Step Count

  A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4

• Spatiotemporal Parameters of Gait : Cadence

  A baseline assessment without wearing the device will be conducted on the same day as session 1, and an end-point assessment while wearing the device will be conducted on the same day as session 4

Study Arms (1)

Wearing conditions of Electrically Powered Orthopedic Exercise Device

EXPERIMENTAL

Participants will undergo gait and balance function tests under both non-wearing and wearing conditions of the electrically powered orthopedic exercise device

Device: Electrically Powered Orthopedic Exercise Device

Interventions

Electrically Powered Orthopedic Exercise Device DEVICE

Participants who pass the screening undergo an evaluation of gait function and balance ability without wearing the Electrically Powered Orthopedic Exercise Device. Afterward, the patient wears the motorized orthopedic exercise device for a total of four adaptation sessions. In each session, the patient performs short-distance walking within 10 meters while wearing the device to explore the appropriate assistive mode and level of support that match their physical condition. No evaluations are conducted while wearing the device during sessions 1, 2, and 3. After the 4th session, an evaluation identical to the one conducted without the device is performed while wearing it, and a satisfaction survey is conducted.

Wearing conditions of Electrically Powered Orthopedic Exercise Device

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yongin Severance Hospital

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

RECRUITING

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  BACKGROUND

Study Officials

• Na Young Kim, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Na Young Kim, MD, PhD

CONTACT

+82 010 9127 4482; kny8452@yuhs.ac

Hwi Woo Yang

CONTACT

+82 010 7360 4439; Rehab5@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Researchers will compare non-wearing and wearing conditions of the electrically powered orthopedic exercise device walking speeds, spatiotemporal parameters, balance in participants and does not establish a control group.

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: August 29, 2025
• Study Start: April 7, 2025
• Primary Completion: April 6, 2026
• Study Completion: April 6, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)