Tokyo, March 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060873) titled 'A Study Observing the Rehabilitation Course Using the Robot Suit HAL in Patients with Brain Injury' on March 10.

Study Type: Observational

Primary Sponsor: Institute - Tokushima University

Condition: Condition - patients with brain injury Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to quantitatively assess the temporary improvement in motor function induced by HAL-assisted movement in patients with brain injury, and to evaluate the feasibility of rehabilitation using the HAL system. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 15 years-old = Gender - Male and Female Key inclusion criteria - Patients who have sustained a brain injury and are currently hospitalized at Tokushima University Hospital. Patients with lower-limb paralysis who have difficulty achieving independent ambulation. Adult patients who can understand the explanation and provide informed consent, or minors for whom consent can be obtained from a parent or legal guardian. Patients whose body size allows safe and appropriate fitting of the HAL device. Patients who are able to undergo standard rehabilitation therapies such as physical therapy, occupational therapy, and orthotic therapy. Patients who will receive rehabilitation using HAL as part of routine clinical care. Key exclusion criteria - Uncontrolled cardiovascular disease. Uncontrolled respiratory disease. Cognitive impairment that makes it difficult to understand explanations or follow instructions. Moderate to severe joint disorders, such as significant joint contractures. Moderate to severe involuntary movements, ataxia, or postural reflex disturbances. Severe spasticity. Target Size - 100

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2018 Year 05 Month 23 Day Date of IRB - 2018 Year 05 Month 23 Day Anticipated trial start date - 2019 Year 04 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069649

Disclaimer: Curated by HT Syndication.