Clinical Trial: Effects of Purposeful Activity-Based Electrical Stimulation Therapy on Brain Function in Patients with Severe Upper Limb Hemiparesis in Chronic Stroke: A Crossover Randomized Controlled Trial (Japan)

Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061268) titled 'Effect of Purposeful Activity-Based Electrical Stimulation Therapy on Severe Upper Limb Paralysis in Chronic Stroke Patients' on June 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Gunma Paz University

Condition: Condition - Chronic stroke with severe upper limb hemiparesis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the effectiveness of purposeful activity-based electrical stimulation therapy (PA-EST) in patients with severe upper limb hemiparesis in chronic stroke, and to compare its effects on brain function and motor function with those of stretching therapy. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Purposeful activity-based electrical stimulation therapy (PA-EST) PA-EST consists of functional electrical stimulation combined with purposeful upper limb activities tailored to the participants daily life goals in patients with severe upper limb hemiparesis after chronic stroke. The intervention period is 3 months. Home-based training is performed twice daily for 5-30 minutes per session, at least 3 times per week. In addition, therapist-guided training focusing on daily activities and instruction on the use of the affected upper limb in daily life are provided. Interventions/Control_2 - Stretching therapy Stretching therapy consists of stretching exercises for the affected upper limb in patients with severe upper limb hemiparesis after chronic stroke. The intervention period is 3 months. Home-based training is performed twice daily for 5-30 minutes per session, at least 3 times per week. In addition, occupational therapy focusing on daily activities and instruction on the use of the affected upper limb in daily life are provided.

Eligibility: Age-lower limit - 30 years-old = Gender - Male and Female Key inclusion criteria - Patients with chronic stroke, defined as more than 1 year since onset Severe upper limb hemiparesis with a Fugl-Meyer Assessment (FMA) upper extremity score of <33 Minimal voluntary movement of the affected upper limb Living at home Receiving occupational therapy Able to communicate in daily conversation No higher brain dysfunction that interferes with daily life Key exclusion criteria - Presence of a cardiac pacemaker Malignant lesions at the stimulation site Fracture, dislocation, or other local disorders at the stimulation site Severe cognitive impairment that interferes with daily communication Higher brain dysfunction that interferes with daily life Considered unsuitable for participation by the investigator or attending physician Target Size - 10

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2023 Year 02 Month 10 Day Date of IRB - 2023 Year 02 Month 10 Day Anticipated trial start date - 2023 Year 03 Month 01 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070105

Disclaimer: Curated by HT Syndication.