Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059903) titled 'Safety and efficacy of home-based neuromuscular electrical stimulation device in patients with Charcot-Marie-Tooth disease: a randomized controlled crossover trial' on Dec. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Kyoto prefectural university of medicine

Condition: Condition - Charcot-Marie-Tooth disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy and safety of the NMES device "FootFit" (MTG Co.,Ltd.) in improving muscle strength and functional outcomes in patients with CMT. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Neuromuscular electrical stimulation training for lower leg muscles Interventions/Control_2 - Control

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Eligible participants were aged 20 years or older with a confirmed diagnosis of CMT by genetic testing. Additionally, participants were required to be ambulatory with or without support. Key exclusion criteria - Exclusion criteria were as follows: no muscle contraction of the lower leg muscles observed with the NMES device; History of lower extremity trauma; already undergoing NMES training at the time of informed consent; comorbid peripheral neuropathy other than CMT or muscle disease; use of medications that may affect nerves or muscles; or excessive alcohol consumption; presence of implantable medical electrical devices such as pacemakers; presence of metallic implants such as metal plates in the lower extremities; pregnant or lactating women; any other safety-related reasons deemed inappropriate for study participation by the principal investigator or co-investigators. Target Size - 40

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2021 Year 09 Month 28 Day Date of IRB - 2022 Year 03 Month 25 Day Anticipated trial start date - 2022 Year 11 Month 17 Day Last follow-up date - 2025 Year 05 Month 13 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068509

Disclaimer: Curated by HT Syndication.