Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061859) titled 'Development of a Prediction Model for Recovery of Upper Limb Motor Function in Patients with Stroke in the Subacute Phase' on June 30.
Study Type:
Observational
Primary Sponsor:
Institute - Nagoya City University Rehabilitation Hospital
Condition:
Condition - Stroke
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to develop a prediction model for the severity of upper limb motor impairment at 1, 2, and 3 months after the initial assessment, based on admission data from patients with moderate to severe upper limb motor impairment after stroke in the subacute phase.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Stroke patients with cerebral infarction or intracerebral hemorrhage whose onset occurred between April 1, 2025 and March 31, 2028.
2) 18 years or older at the initial assessment.
3) Time from stroke onset to the initial assessment between 7 and 56 days.
4) Fugl-Meyer Assessment for Upper Extremity score of 47 or lower at the initial assessment.
5) Continued hospitalization for at least 1 month after the initial assessment.
Key exclusion criteria - 1) Subarachnoid hemorrhage.
2) Inability to receive at least 3 units of rehabilitation therapy on 20% or more of hospitalization days.
3) Upper limb pain interfering with rehabilitation for improvement of upper limb motor function.
4) Missing values in three or more predictor variables.
5) Cerebellar ataxia ipsilateral to an infratentorial lesion.
6) Bilateral upper limb motor paresis due to recurrent stroke, making the Thumb Localizing Test difficult to perform.
Target Size - 1000
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 04 Month 05 Day
Date of IRB - 2026 Year 05 Month 16 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2028 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070516
Disclaimer: Curated by HT Syndication.