Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063321) titled 'Effects of Stepping Exercise Using the Non-paralyzed Leg on Muscle Oxygen Levels in the Paralyzed Leg of Stroke Patients' on Oct. 16.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tokyo Saiseikai Central Hospital

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

Objective: Narrative objectives1 - To measure muscle oxygen saturation (SmO2) of the paretic gastrocnemius (lateral head) and tibialis anterior muscles during non-paretic leg stepping exercise in patients with acute stroke, and to clarify the effect of dynamic paretic-side loading on SmO2 as well as the feasibility of this protocol. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Non-paretic leg stepping exercise. Patients perform stepping exercise with the non-paretic leg while wearing a long leg orthosis and holding onto parallel bars (3 sets of 30 seconds, over 5 weekdays).

Eligibility: Age-lower limit - 60 years-old = Gender - Male and Female Key inclusion criteria - (1) First-ever cerebral infarction or hemorrhage, aged 60-85 years; (2) Functional Ambulation Categories (FAC) 2 or less (with long leg orthosis) and lower-limb Brunnstrom Stage IV or less at initial assessment; (3) Able to maintain standing with parallel bar support under close supervision while wearing a long leg orthosis; (4) Good comprehension of instructions. Key exclusion criteria - (1) Difficulty with independent walking (FAC 3 or less) before onset; (2) Orthopedic conditions such as fractures, or severe contracture; (3) Pusher phenomenon (Scale for Contraversive Pushing 1 or more); (4) Bilateral lesions; (5) Parkinsonism; (6) Cerebellar disease; (7) Unstable general condition (severe disturbance of consciousness, anemia, deep vein thrombosis, oxygen therapy, or vital sign changes requiring urgent medical attention persisting for 2 days); (8) Patients already flagged by a physician or nurse for skin injury risk prior to physical therapy intervention. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 16 Day Anticipated trial start date - 2027 Year 01 Month 12 Day Last follow-up date - 2028 Year 01 Month 12 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072470

Disclaimer: Curated by HT Syndication.