Study on Gait Analysis of Total Hip Arthroplasty Patients Using a Hip Abduction HAL

JRCT ID: jRCTs032240437

Registered date:28/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: hip joint disease
• Date of first enrollment: 28/10/2024
• Target sample size: 40
• Study type: Interventional

Intervention(s)

During weekdays of the hospital stay, starting from the first postoperative day, patients will undergo hip abduction training with or without HAL alongside standard rehabilitation. HAL-assisted training starts on the third postoperative day.

Standard Rehabilitation Protocol:

Postoperative Day 1: Mobilization, wheelchair transfer, toilet movement training.
Postoperative Day 2 onward: Gait training with a walker, hip joint range of motion exercises, bed mobility training.
Postoperative Day 7 onward: Gait training with a T-cane or independent walking, stair climbing, and daily activity assessments.
Hip Abduction Training with HAL:

Conducted four times within the first two weeks postoperatively on days 7, 9, 11, and 14, with a one-day variation allowed based on patient condition.
Training consists of 10 repetitions per set, with 5 sets per day. Rest periods are adjusted to the patient's physical condition.
On days without HAL, the same hip abduction training (10 reps per set, 5 sets per day) will be conducted.
Standard rehabilitation and training time is approximately 40 minutes, including HAL setup. On evaluation days, an additional 60 minutes will be added.

Outcome(s)

• Primary Outcome: Change in pelvic tilt variation (variation in pelvic tilt in the frontal plane and symmetry ratio) from preoperative to 3 months postoperative as measured by a 3D motion analysis system. An increase or decrease of more than 10% from the reference value in the symmetry ratio is considered abnormal (a symmetry ratio of 0.9-1.1 is considered normal).

Secondary Outcome

Feasibility of Protocol Implementation: Up to 2 weeks postoperatively.
Hip Range of Motion (Active and Passive): Measured twice using a goniometer according to guidelines from the Japanese Orthopaedic Association and Rehabilitation Medicine Association (1995).
Hip Muscle Strength: Assessed using a Hand Held Dynamometer for flexion, extension, abduction, and adduction.
Lower Limb Length: Measured as the straight-line distance from the anterior superior iliac spine to the medial malleolus.
Pain Assessment: Using the Visual Analogue Scale.
Gait Ability Assessment: Involves a 10 meter walk to measure time, steps, gait speed, stride length, and cadence.
Simple X-ray Evaluation: Assesses Hip offset (Femoral offset, Acetabular offset).
Simple CT Evaluation: Measures the cross-sectional area of the gluteus medius muscle at the lowest sacroiliac joint level.
Hip Function Scores: Includes the Harris Hip Score, Hip Joint JOA Score, and JHEQ.
3D Motion Analysis: Conducted with the Ultium MyoMotion system (Noraxon) during a 10-meter walk, evaluating gait parameters (speed, stride length, cadence), joint range of motion/moments (pelvic tilt/rotation, hip flexion-extension, internal-external rotation, abduction-adduction, knee flexion-extension, ankle plantar-dorsiflexion, inversion-eversion, internal-external rotation), center of pressure, and muscle activity (gluteus medius, gluteus maximus, quadriceps, biceps femoris, tensor fasciae latae).
Maximum Voluntary Muscle Contraction: Assessed using surface electromyography with Ultium MyoMotion (Noraxon). Electrode placement follows SENIAM guidelines. Muscle contraction during maximum isometric exercises for hip abduction, extension, and knee flexion/extension is measured in appropriate resting positions.
Pelvic Tilt Variation: Monitored via 3D motion analysis from preoperative to 1 week, 2 weeks, 1 month, 6 months, and 1 year postoperative.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients aged 18 or older who have been diagnosed with hip joint disease by an orthopedic specialist through X-ray and MRI imaging, and are scheduled to undergo their first total hip arthroplasty (THA).
2) Patients who are able to attend regular follow-up visits throughout the entire study period
3) Patients who have received a thorough explanation of the study, fully understand it, and have given written consent of their own free will to participate in the study.

Exclude criteria

1) Patients who are deemed unable to wear the HAL or undergo training due to underlying diseases.
2) Patients with bleeding tendencies or severe complications that interfere with daily life (such as respiratory or circulatory diseases) or infections that pose problems during training.
3) Patients whose body size is not suitable for HAL application (height outside the range of 150-190 cm or weight outside the range of 40-100 kg).
4) Patients with significant body deformities, such as in the legs, making it difficult to wear the device.
5) Patients with skin conditions that prevent the attachment of HAL's bioelectrodes.
6) Patients with cognitive impairments that make it difficult to understand explanations or instructions.
7) Patients with moderate or severe joint disorders, such as joint contractures, after surgery.
8) Patients with moderate or severe involuntary movements, ataxia, or postural reflex impairments.
9) Patients with severe spasticity.
10) Patients participating in clinical trials or other investigational studies.
11) Pregnant patients.
12) Other patients deemed inappropriate as subjects by the principal (or sub-) investigator.

Related Information

• Primary Sponsor: Nishino Tomofumi
• Source(s) of Monetary Support: University of Tsukuba Hospital