Tokyo, June 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061853) titled 'Feasibility of upper limb electrical stimulation rehabilitation triggered by motor imagery: An exploratory single-arm study' on June 10.

Study Type: Interventional

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

Primary Sponsor: Institute - kYOTO UNIVERSITY

Condition: Condition - Upper limb paresis due to stroke, neurotrauma, or spinal cord injury Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the feasibility and effectiveness of rehabilitation using a motor-imagery-triggered neuromodulation device (WILMO) in patients with upper limb paresis, and to elucidate the underlying neurophysiological mechanisms during the functional recovery process. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Both the "with-intervention" condition (using the wilmo wearable voluntary movement-assisted electrical stimulation device) and the "without-intervention" condition (voluntary movement only) are performed within the same day in a randomized order.

With-intervention condition: After measuring maximum grip strength, patients perform 30 repetitions of gripping exercises at 15% load, where muscle contraction is induced by WILMO triggered by motor-intention-related EEG changes (approx. 10 min).

Without-intervention condition: After measuring maximum grip strength, patients perform 30 repetitions of the same gripping exercises using voluntary effort only (approx. 10 min). A 15-to-20-minute rest period (washout) is provided between the two conditions to allow recovery from fatigue.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Patients with stroke, neurotrauma, or spinal cord injury admitted to the Department of Neurology or Department of Neurosurgery at Kyoto University Hospital.

Patients presenting with upper limb paresis graded from 0/5 to 4/5 on the Manual Muscle Test (MMT).

Patients aged between 18 and 75 years.

Patients who can fully understand the study explanation and provide written informed consent. Key exclusion criteria - Patients with impaired consciousness (Japan Coma Scale score of 2 digits or higher) who cannot understand explanations or instructions.

Patients with dementia who cannot understand explanations or instructions. Target Size - 25

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 01 Day Anticipated trial start date - 2026 Year 06 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=R000070775

Disclaimer: Curated by HT Syndication.