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

Condition(s) studied

Investigational drug(s) / intervention(s)

Electrically Powered Orthopedic Exercise 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 10-Meter 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
  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.

Trial sites (1)

More Yonsei University trials in South Korea