JPRN-jRCTs032190053
Recruiting
Phase 1
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
Yamazaki Masashi0 sites30 target enrollmentJuly 8, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yamazaki Masashi
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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