Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063111) titled 'Exploratory study of stimulation-site selection and individualized intervention using sensory-threshold neuromuscular electrical stimulation in patients with post-stroke hemiparesis' on Sept. 30.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Ukai Rehabilitation Hospital

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

Objective: Narrative objectives1 - To compare the immediate effects of sensory-level neuromuscular electrical stimulation (S-NMES) applied to the tibialis anterior and triceps surae on postural control and gait in patients with post-stroke hemiparesis, and to explore changes in balance and gait following a 2-week individualized intervention in which the stimulation site is selected based on the immediate response. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - During the immediate assessment, sensory-level neuromuscular electrical stimulation (S-NMES) is applied to the paretic tibialis anterior (TA) on Day 1 and to the paretic triceps surae (TS) on Day 2. On each stimulation day, measurements are performed before S-NMES under the no-stimulation condition and then during S-NMES. Stimulation parameters are 100 Hz, a pulse width of 200 microseconds, an intensity approximately 1.5 times the sensory threshold without visible muscle contraction, and a stimulation duration of 40 minutes. After completion of the immediate assessments for both TA and TS stimulation, the stimulation site for the 2-week intervention is individually selected based on the improvement rate in mediolateral CoP path length during standing with eyes closed. S-NMES is then applied to the selected site once daily for 40 minutes on intervention days for 2 weeks. Interventions/Control_2 - During the immediate assessment, sensory-level neuromuscular electrical stimulation (S-NMES) is applied to the paretic triceps surae (TS) on Day 1 and to the paretic tibialis anterior (TA) on Day 2. On each stimulation day, measurements are performed before S-NMES under the no-stimulation condition and then during S-NMES. Stimulation parameters are 100 Hz, a pulse width of 200 microseconds, an intensity approximately 1.5 times the sensory threshold without visible muscle contraction, and a stimulation duration of 40 minutes. After completion of the immediate assessments for both TA and TS stimulation, the stimulation site for the 2-week intervention is individually selected based on the improvement rate in mediolateral CoP path length during standing with eyes closed. S-NMES is then applied to the selected site once daily for 40 minutes on intervention days for 2 weeks.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Patients aged 20 years or older with first-ever unilateral stroke and hemiparesis whose general condition is stable. 2.Patients who are able to maintain quiet standing with the feet together for 60 seconds without physical assistance. 3.Patients who are able to walk 10 m with supervision. 4.Patients in whom the sensory threshold can be determined and sensory-level electrical stimulation according to the study protocol can be safely applied. 5.Patients who receive written and verbal explanations of the study and provide written informed consent. Key exclusion criteria - 1.Patients with neurological diseases other than stroke. 2.Patients with severe orthopedic disorders that clearly affect balance. 3.Patients with severe peripheral neuropathy. 4.Patients with visual impairment such as hemianopia that interferes with study procedures, severe hearing impairment, dizziness, or evident vestibular disorders. 5.Patients who are unable to safely and consistently complete the study procedures because of cognitive or communication impairment. 6.Patients with conditions for which electrical stimulation is considered unsafe, such as the use of implanted electrical devices. 7.Patients considered unsuitable for participation by the principal investigator for safety reasons or because of concerns regarding interpretation of the data. Target Size - 5

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 27 Day Anticipated trial start date - 2026 Year 10 Month 15 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072247

Disclaimer: Curated by HT Syndication.