Electrically powered leg exercise device to improve walking after hip surgery

Study to Verify the Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients Who Have Undergone Hip Surgery: Investigator-Initiated, Single-Center, Single-Group Clinical Trial

This will test whether an electrically powered orthopedic exercise device helps people who recently had hip surgery walk farther, faster, and keep their balance better.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Yonsei University (other)
• Locations: 1 site (Yongin-si, Gyeonggi-do, South Korea)
• Trial ID: NCT07147491 on ClinicalTrials.gov

What this trial studies

This pilot, single-group Phase 4 study will enroll 30 adults who have undergone hip surgery and are medically stable. Participants will complete standardized gait and balance tests (10-Meter Walk Test, 6-Minute Walk Test, Timed Up and Go, Berg Balance Scale) both without and while wearing the electrically powered orthopedic exercise device, with supervised application and rest periods. Clinical and safety data will be collected by rehabilitation specialists and assistants and recorded in case report forms. Outcomes will compare walking speed, endurance, and balance between non-wearing and wearing conditions to estimate potential benefit and device safety.

Who should consider this trial

Good fit: Adults aged 19 or older who are at least two days post-hip surgery for hip osteoarthritis, avascular necrosis of the femoral head, or hip fracture, are medically stable, have adequate cognition (K-MMSE ≥20), can sit and stand briefly, and have a Functional Ambulatory Category (FAC) of 1–3 are ideal candidates.

Not a fit: Patients with active surgical-site problems (exudate, heat, redness, swelling, severe pain), contraindications to lower-limb weight-bearing such as severe joint contractures or advanced osteoporosis, or insufficient cognitive/functional ability are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could improve walking speed, endurance, and balance after hip surgery and help reduce fall risk during recovery.

How similar studies have performed: Small studies of wearable robotic or powered orthoses have shown promising gait improvements after lower-limb injury or surgery, but direct evidence specifically after hip surgery is limited.

Eligibility criteria

Inclusion Criteria:

1. Individuals aged 19 or older
2. Individuals who have undergone hip surgery due to hip osteoarthritis, avascular necrosis of the femoral head, or hip fracture
3. Individuals who are at least two days post-hip surgery and are assessed to be medically stable
4. Individuals who have adequate cognitive ability (Korean Mini-Mental State Examination score ≥ 20)
5. Individuals able to sit at the edge of a bed without assistance and stand for 10 seconds regardless of support
6. Individuals who are Functional Ambulatory Category (FAC) score of 1-3
7. Individuals who visited Yongin Severance Hospital, understood the study, and signed informed consent

Exclusion Criteria:

1. 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
2. Individuals who have contraindications for lower limb weight-bearing such as severe joint contractures, osteoporosis, or untreated fractures
3. Individuals who have progressive or unstable brain diseases or neurological paralysis from stroke
4. Individuals who have active infections or open wounds hindering device use
5. Individuals who have significant leg length discrepancies
6. Individuals who have severe deformities or contractures in the lower extremities
7. Individuals who have history of poliomyelitis
8. Individuals inable to maintain seated or standing positions independently
9. Individuals who have severe spasticity (Modified Ashworth Scale grade ≥ 2)
10. Individuals who have bone metastases from cancer
11. Individuals who have severe internal diseases affecting device use (e.g., cardiovascular or respiratory diseases)
12. Individuals who have cognitive impairments preventing cooperation with device use
13. Individuals who have complaints of device-related side effects or potential rehabilitation discontinuation (e.g., severe obesity, skeletal deformity)
14. Patients who are determined to be pregnant or potentially pregnant based on the medical interview
15. Individuals who have any other clinically significant findings deemed inappropriate by the investigator

Where this trial is running

Yongin-si, Gyeonggi-do, South Korea

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

Study contacts

• Principal investigator: Na Young Kim, MD, PhD — Severance Hospital
• Study coordinator: Na Young Kim, MD, PhD

Conditions: Hip Surgery, Rehabilitation, Gait, Wearable robot