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

Safety trial of knee joint training using the wearable cyborg HAL (single-joint type) for the knee osteoarthritis - Safety trial of knee joint training using the HAL for the knee osteoarthritis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032240047

Enrollment

Registered

2024-04-25

Start date

2024-07-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

knee osteoarthritis

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Completion rate of HAL intervention	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Contacts

Public ContactYuichiro Soma

University of Tsukuba

ysoma@md.tsukuba.ac.jp+81-29-853-3219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026