Electrically powered leg exercise device to improve walking after hip surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: kny8452@yuhs.ac
• Phone: +82 010 9127 4482

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Quadro-Iliac Plane Block for Hip Surgery: Observational Insights

  This study tests how well the QIP block, used during hip surgery, works for pain and recovery compared with other regional anesthesia techniques.

  Recruiting at 2 sites San Giovanni di Dio Hospital · Crotone and 1 other locations · NCT07591311

• PENG versus Deep Iliacus Plane block for pain relief in intertrochanteric femur fractures

  This study will see if PENG or Deep Iliacus Plane nerve blocks give better pain relief and make positioning for spinal anesthesia easier for adults having surgery for intertrochanteric hip fractures.

  Recruiting Erzincan Binali Yildirim Universitesi · Erzincan, Merkez/Türkiye · NCT07513740

• Regional nerve blocks for anterior-approach hip replacement (SIFI vs ESP)

  This trial will test whether adding a supra-inguinal fascia iliaca (SIFI) block or an erector spinae plane (ESP) block can reduce early pain and opioid side effects after elective anterior approach total hip replacement in adults.

  Recruiting A.O.U. Città della Salute e della Scienza · Torino, TO · NCT07017192

• Using melatonin to improve recovery in teens after surgery

  This study is testing if melatonin can help teenagers recover better and sleep well after having major surgery.

  Recruiting Stanford University · Palo Alto, California · NCT06093477

• Long-term follow-up after hip surgery with FH ORTHO implants

  This follow-up will collect real-world safety and performance data on FH ORTHO hip implants in adults who receive them.

  Recruiting at 5 sites Fh Ortho · Guilherand-Granges and 4 other locations · NCT05966220

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.