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

JRCT ID: jRCTs032190053

Registered date:08/07/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Anterior cruciate ligament injury
• Date of first enrollment: 06/08/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Knee flexion and extension exercise using knee wearable robot

Outcome(s)

• Primary Outcome: Adverse event, device trouble
• Secondary Outcome: feasibility of study,Knee joint movement range, knee joint muscle strength, walking, balance

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: < 50age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yamazaki Masashi