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Safety of knee extension and flexion training using the HAL-SJ for patients with ACL injury

Evaluation of safety of knee extension and flexion training using the wearable motion support robot (single joint type of Hybrid Assistive Limb (HAL-SJ)) for patients with anterior cruciate ligament injury - Evaluation of safety of knee extension and flexion training using the wearable motion support robot (single joint type of Hybrid Assistive Limb (HAL-SJ)) for patients with anterior cruciate ligament injury

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032190053
Enrollment
30
Registered
2019-07-08
Start date
2019-08-06
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

Anterior cruciate ligament injury

Interventions

Knee flexion and extension exercise using knee wearable robot

Sponsors

Yamazaki Masashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients with ACL-injured patients and ACL reconstructive surgery who were consulted at our hospital orthopedic surgery 1.Primary ACL injured patients 2.Patients with harvested are semitendinosus tendon alone or both semitendinosus and gracilis tendons 3.Be observable throughout the entire research period 4.Patients who weigh 40-100 kg and height 150-190 cm and are able to wear HAL 5.Patient who can accept document consent

Exclusion criteria

Exclusion criteria: Patients who conflict with one of the following criteria are excluded and are not subject to this clinical study 1.Patients with multiple knee ligament injuries 2.Bilateral simultaneous surgery patient 3.Patients who are considered difficult to wear and train HAL due to underlying disease or perioperative complications 4.Patients with bleeding tendencies or complications that are problematic for training 5.Patients who can not affix HAL biological electrode due to skin diseases or other things 6.Patients who had participated in other research within 12 weeks of starting this clinical study 7.Patients who judged that participation in this study is inappropriate by clinical trial responsible doctor or clinical trial sharing doctor

Design outcomes

Primary

MeasureTime frame
Adverse event, device trouble

Secondary

MeasureTime frame
feasibility of study,Knee joint movement range, knee joint muscle strength, walking, balance

Contacts

Public Contacttomokazu Yoshioka

University of Tsukuba Hospital

tymd99@tsukuba-seikei.jp+81-29-853-3219

Outcome results

None listed

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