Tokyo, Sept. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062955) titled 'A study of meaningful change in Gait Assessment and Intervention Tool scores in patients with chronic stroke' on Sept. 16.
Study Type:
Observational
Primary Sponsor:
Institute - Keio University
Condition:
Condition - Chronic post-stroke hemiparesis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To estimate the minimal important difference (MID), defined as the smallest clinically meaningful change in G.A.I.T. scores, and examine its relationship with the smallest detectable change (SDC) in patients with chronic stroke.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients with chronic stroke at least 6 months after stroke onset.
Patients with hemiparesis.
Patients aged 18 years or older.
Patients with Functional Ambulation Category (FAC) level 4 or 5, with or without walking aids or orthoses.
Patients able to safely perform the walking tasks required for G.A.I.T. assessment.
Key exclusion criteria - Patients who have difficulty understanding instructions or responding to the Global Rating of Change (GROC).
Patients who are medically unstable.
Patients with pain affecting gait.
Patients with orthopedic conditions affecting gait.
Patients considered unsuitable for participation by the principal investigator or treating physician.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 25 Day
Date of IRB - 2026 Year 05 Month 25 Day
Anticipated trial start date - 2026 Year 09 Month 17 Day
Last follow-up date - 2030 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072072
Disclaimer: Curated by HT Syndication.
