NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032190053

Registered date:08/07/2019

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedAnterior cruciate ligament injury
Date of first enrollment06/08/2019
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)Knee flexion and extension exercise using knee wearable robot

Outcome(s)

Primary OutcomeAdverse event, device trouble
Secondary Outcomefeasibility of study,Knee joint movement range, knee joint muscle strength, walking, balance

Key inclusion & exclusion criteria

Age minimum>= 15age old
Age maximum< 50age old
GenderBoth
Include criteriaAll 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 criteriaPatients 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

Contact

Public contact
Name tomokazu Yoshioka
Address 2-1-1 Amakubo Tsukuba Ibaraki, Japan Ibaraki Japan 305-8575
Telephone +81-29-853-3219
E-mail tymd99@tsukuba-seikei.jp
Affiliation University of Tsukuba Hospital
Scientific contact
Name Masashi Yamazaki
Address 2-1-1 Amakubo Tsukuba Ibaraki, Japan Ibaraki Japan 305-8575
Telephone +81-29-853-3219
E-mail masashiy@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital