Safety trial of knee joint training using the HAL for the knee osteoarthritis

JRCT ID: jRCTs032240047

Registered date:25/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: knee osteoarthritis
• Date of first enrollment: 25/04/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): The principal investigator or participating physician conducts eligibility assessments and obtains consent before the HAL intervention. The HAL single-joint type is worn on the lower limb affected by knee deformity (the side with stronger symptoms), and a total of 10 sessions are conducted, with a frequency of 2-3 times per week. The HAL program comprises knee joint range of motion training through knee extension movements and seated-to-standing training under HAL assistance, totaling approximately 20 minutes. Major and secondary assessments are conducted before each HAL session and after the completion of all HAL sessions. Evaluations following the conclusion of each HAL session are performed within 7 days. Major assessments are conducted at each HAL session. The follow-up period extends up to 6 months after the completion of the HAL intervention.

Outcome(s)

• Primary Outcome: Completion rate of HAL intervention

Secondary Outcome

Gait analysis using 3D motion analysis and surface electromyography
Changes in vital signs before and after intervention (blood pressure, pulse rate, respiratory rate, SpO2)
Knee joint pain (VAS: Visual Analogue Scale)
Number of new prescriptions for hyaluronic acid injections and analgesics for knee pain that worsened due to the HAL intervention
WOMAC
Time up and go test
Six-minute walk
Knee flexion/extension range of motion
Knee isokinetic/isotonic knee extension and flexion muscle strength evaluation (using BIODEX system4)
Knee injury and Osteoarthritis Outcome Score (KOOS): Subjective, patient-oriented evaluation of the knee joint
Body Composition Analysis (Body Composition Analyzer In Body720)
EQ-5D-5L (EuroQol 5-dimensions 5-levels)
HAL settings (mode setting, angle setting, assist amount, torque limit setting)

Key inclusion & exclusion criteria

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

Include criteria

1) Adult patients 18 years of age or older who are able to give written consent
2) Patients diagnosed with knee osteoarthritis through X-ray imaging by a physician
3) Patients with a weight between 40-100 kg and a height between 150-190 cm, capable of wearing the HAL. However, patients outside the specified height range can still be eligible if their body size allows for HAL fitting
4) Patients who can be observed throughout the entire study period.

Exclude criteria

1) Patients for whom surgery, such as joint replacement, has been determined at the start of the study
2) Patients unable to affix HAL bioelectrodes due to skin conditions or other dermatological issues
3) Patients deemed inappropriate for participation in this clinical trial by the principal investigator or participating clinical trial physicians.

Related Information

• Primary Sponsor: Hada Yasushi
• Source(s) of Monetary Support: University of Tsukuba Hospital