Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062578) titled 'A study on the reproducibility of NIRS-based classification indices for stroke upper-limb rehabilitation' on Aug. 14.
Study Type:
Observational
Primary Sponsor:
Institute - Kyoto Ohara Memorial Hospital
Condition:
Condition - Stroke (hemorrhagic or ischemic), convalescent phase, upper-limb hemiparesis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To quantify the test-retest reliability of the continuous laterality indices (Wrist D_raw, Tap Diff) and the derived type labels (Type A/B/C) of an NIRS-based classifier using same-day repeated measurements that exclude true change (rTMS effect and spontaneous recovery), and to judge, by a pre-specified decision rule, whether it is usable for individual-level treatment allocation.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
= 48 (very mild)
Cannot meet the functional floor (severe disturbance of consciousness, severe receptive aphasia, or severe cognitive impairment preventing stable task performance)
Marked involuntary movement precluding stable task performance
Scheduled rTMS or other cortical-excitability-modifying intervention on the day of measurement (the measurement period refers to three consecutive measurements within the same session on a single day; planned rTMS after the measurement day is not an exclusion criterion)
Scalp/skull condition unsuitable for probe attachment
Non-consent
Target Size - 31
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 13 Day
Anticipated trial start date - 2026 Year 08 Month 30 Day
Last follow-up date - 2029 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071463
Disclaimer: Curated by HT Syndication.
