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

NCT07147491 | Recruiting Phase 4

• 1 other identifier: 9-2025-0017
• 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. 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

Hip Surgery

Keywords

Rehabilitation; Gait; Wearable robot; Hip Surgery

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 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 assessed to be medically stable
• Individuals who have adequate cognitive ability (Korean Mini-Mental State Examination score ≥ 20)
• 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

You may not qualify if:

• Individuals who, after undergoing hip surgery, present with exudate at the surgical site or report symptoms such as heat, redness, swelling, or severe pain at the affected area
• 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 (e.g., severe obesity, skeletal deformity)
• 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

Related Publications (30)

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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)