Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058764) titled 'Effect of Electrical Stimulation Device for Upper Limb Paralysis' on Feb. 1.

Study Type: Observational

Primary Sponsor: Institute - Kyoto Prefectural University of Medicine

Condition: Condition - Upper limb paralysis caused by central nervous system diseases such as stroke (cerebral infarction, intracerebral hemorrhage, subarachnoid hemorrhage), head injury, cervical spinal cord injury, cervical spondylotic myelopathy, and syringomyelia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Evaluate upper limb use and improvement in voluntary movement in daily life situations using a Wearable Integrated Volitional control Electrical Stimulation (WIVES) device. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old = 18 years at the time of consent. 3.No restriction on sex. 4.No restriction on inpatient or outpatient status. 5.Able to independently or with assistance wear and operate the WIVES device. 6.Voluntary muscle activity of the target muscle is present when subthreshold electrical stimulation is applied. Key exclusion criteria - 1. Severe limitation of wrist joint range of motion (wrist dorsiflexion < 0 degree). 2. Severe sensory impairment (loss of superficial or deep sensation). 3. Severe higher brain dysfunction (Mini-Mental State Examination score <= 23). 4. Presence of any of the following conditions: Heart disease, Pacemaker implantation, Infectious disease, Abnormal blood pressure, Skin disease at the electrode site, Malignant tumor, Metallic implant in the upper limb, Acute illness, Possible circulatory disturbance, Pregnancy or possible pregnancy 5. Deemed inappropriate for participation by the attending physician. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 08 Day Anticipated trial start date - 2025 Year 10 Month 01 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=R000067192

Disclaimer: Curated by HT Syndication.