Tokyo, Dec. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060030) titled 'Effects of Gait Training Using knee ankle foot orthosis with Knee Extension Assist Mechanisms on Muscle Activity in the Paretic Rectus Femoris Muscle in Subacute Stroke Hemiplegic Patients' on Dec. 10.

Study Type: Observational

Primary Sponsor: Institute - Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)

Condition: Condition - stroke Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to clarify the changes in muscle activity of the paretic lower limb that result from one month of walking practice using a knee-ankle-foot orthosis (KAFO) with a knee extension assist mechanism in stroke patients with hemiplegia presenting with severe gait impairment in the subacute phase. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with hemiplegia due to stroke admitted to our hospital's recovery-phase rehabilitation ward between August 2023 and February 2025. Patients for whom cerebrovascular disease rehabilitation fees were billed. Patients for whom a custom-made long leg orthosis (KAFO) was fabricated with the goal of improving walking ability. Patients for whom the necessity of KAFO was discussed by a team including a rehabilitation specialist during an orthotic consultation. Patients for whom lower limb muscle activity (EMG) data could be obtained at baseline and 1 month (1M) post-intervention. Patients who provided consent to participate in this study (consent for participation in the study or use of existing data, as this is a retrospective study). Key exclusion criteria - Individuals for whom the purpose of KAFO fabrication was not to acquire walking ability, but rather to improve durability. Individuals prescribed bilateral KAFOs. Individuals with significant orthopedic conditions (as these may affect walking ability). Individuals who were not experiencing their first stroke. Individuals with missing values in the data required for analysis (muscle activity data or FIM scores). Individuals who withdrew during the study period due to poor health or other reasons. Target Size - 20

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2023 Year 07 Month 31 Day Date of IRB - 2024 Year 04 Month 30 Day Anticipated trial start date - 2023 Year 08 Month 01 Day Last follow-up date - 2025 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067908

Disclaimer: Curated by HT Syndication.