Clinical Trial: Japan Spinal Cord Injury Natural History and Rehabilitation Study (Japan)

Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063057) titled 'Japan Spinal Cord Injury Natural History and Rehabilitation Study' on Sept. 30.

Study Type: Observational

Primary Sponsor: Institute - Keio University

Condition: Condition - Chronic traumatic spinal cord injury Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate longitudinal changes in neurological and activities of daily living functions in patients with chronic traumatic spinal cord injury at least one year after injury, and to characterize the natural history of chronic spinal cord injury in Japan and its association with rehabilitation. The study also aims to assess the feasibility of multicenter data collection, standardized assessment, and data quality management, thereby providing a foundation for a future registry of chronic spinal cord injury and for natural history studies and clinical research. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with traumatic spinal cord injury. 2. Patients who received medical care at a participating institution between January 2012 and March 2030 at least one year after spinal cord injury. 3. Patients aged 18 years or older. 4. Patients who have undergone at least two ISNCSCI assessments at least one year after injury, or who are scheduled to undergo such assessments during the study period. Key exclusion criteria - 1. Patients with non-traumatic spinal cord injury. 2. Patients with apparent cognitive impairment or impaired consciousness. 3. Patients with other conditions affecting limb paralysis or motor function, including severe contractures or limb amputation. 4. Patients whose ISNCSCI assessments are considered to have been inadequately performed. Target Size - 800

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 11 Month 30 Day Anticipated trial start date - 2027 Year 02 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=R000072187

Disclaimer: Curated by HT Syndication.