NIPH Clinical Trials Search

A comparative study of robotic rehabilitation after total hip arthroplasty

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Osteoarthritis of the hip
Date of first enrollment	03/02/2026
Target sample size	60
Countries of recruitment
Study type	Interventional
Intervention(s)	In this study, patients aged 50-79 years old who have undergone total hip replacement surgery for osteoarthritis of the hip will be divided into two groups: one group will undergo training using the HAL Waist Type Independent Support Assist (hereinafter referred to as the HAL wearer group) and one group will undergo training without using HAL (hereinafter referred to as the non-HAL wearer group). Rehabilitation will be carried out in the early post-surgery period, in principle a total of 10 times, and the effects on the post-surgery recovery process of hip joint and walking dynamics and final QOL will be exploratory compared.

Outcome(s)

Primary Outcome

Change from baseline in the Timed Up and Go test (TUG) at 2 weeks after surgery

Secondary Outcome

1) Clinical endpoints: Change from baseline in the Japanese Orthopaedic Association Hip Function Assessment Criteria (JOA Hip score), change from baseline in the Harris Hip score, change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and change from baseline in the SF-36. 2) Change from baseline in the Visual Analogue Scale (VAS). 3) Physical activity measurements. Gait dynamics analysis: Three-dimensional kinetic analysis, changes in hip and knee flexion and extension angles and angular velocity using a markerless posture estimation device, changes in center of gravity height during the gait cycle and vertically, changes in lateral and vertical body movement, and gait (change from baseline in walking speed, change from baseline in stride length, change from baseline in step length, change from baseline in swing-to-stance ratio, and changes in left and right gait cycle variability). (Change from baseline) Center of gravity sway: Change from baseline in total path length and area during one minute of standing using a force plate and center of gravity sway meter. 4) 10 m walk: Change from baseline in time and number of steps required to walk a 10 m walkway. 5) HAL Data: Change from baseline in hip joint angle and angular velocity recorded in the HAL monitor, and change from baseline in bioelectrical signals recorded from the gluteus medius and gluteus maximus.

Key inclusion & exclusion criteria

Age minimum	>= 50age old
Age maximum	< 80age old
Gender	Both
Include criteria	Patients who meet all of the following criteria are eligible for this study: (1) Patients diagnosed with osteoarthritis of the hip by an orthopedic surgeon and scheduled for hip surgery. (2) Patients aged 50 years or older and under 80 years old on the day of enrollment. (3) Height: 140-180 cm, weight: 40-80 kg, abdominal circumference: 120 cm or less, pelvic width: 39 cm or less. However, even if the height and weight are outside the above ranges, patients are eligible for HAL Lumbar Type due to their body dimensions, such as abdominal circumference and pelvic width. (4) Patients whose preoperative walking ability has been determined by a physician to be suitable for standing and walking training. (5) Patients who have provided written consent to participate in this study.
Exclude criteria	Patients who meet any of the following criteria will not be eligible for this study: (1) Patients using implanted active medical devices or electronic devices (e.g., pacemakers) (2) Patients with cardiovascular or respiratory diseases such as myocardial infarction, angina pectoris, hypertension (BP 200/120 mmHg or higher), deep vein thrombosis, or chronic respiratory failure (3) Patients with physical deformities or skin conditions that make it difficult to attach HAL or the electrodes (4) Patients who are unable to communicate due to a history of or complications of psychiatric disorders (5) Patients who are otherwise deemed inappropriate as study participants by the principal investigator/co-investigator