NIPH Clinical Trials Search

JRCT ID: jRCTs032240047

Registered date:25/04/2024

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedknee osteoarthritis
Date of first enrollment25/04/2024
Target sample size30
Countries of recruitment
Study typeInterventional
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.


Primary OutcomeCompletion rate of HAL intervention
Secondary OutcomeGait 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 maximumNot applicable
Include criteria1) 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 criteria1) 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


Public contact
Name Yuichiro Soma
Address 1-1-1 Tennodai,Tsukuba,Ibaraki Ibaraki Japan 305-8575
Telephone +81-29-853-3219
Affiliation University of Tsukuba
Scientific contact
Name Yasushi Hada
Address 2-1-1 Amakubo,Tsukuba,Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3219
Affiliation University of Tsukuba Hospital