UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059903 |
|---|---|
| Receipt number | R000068509 |
| Scientific Title | Safety and efficacy of home-based neuromuscular electrical stimulation device in patients with Charcot-Marie-Tooth disease: a randomized controlled crossover trial |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/27 16:33:42 |
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Basic information
Public title
Safety and efficacy of home-based neuromuscular electrical stimulation device in patients with Charcot-Marie-Tooth disease: a randomized controlled crossover trial
Acronym
Neuromuscular electrical stimulation (NMES) training in CMT
Scientific Title
Safety and efficacy of home-based neuromuscular electrical stimulation device in patients with Charcot-Marie-Tooth disease: a randomized controlled crossover trial
Scientific Title:Acronym
Neuromuscular electrical stimulation (NMES) training in CMT
Region
| Japan |
Condition
Condition
Charcot-Marie-Tooth disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower leg muscle strength
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Neuromuscular electrical stimulation training for lower leg muscles
Interventions/Control_2
Control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yu-ichi |
| Middle name | |
| Last name | Noto |
Organization
Kyoto prefectural university of medicine hospital
Division name
Department of Neurology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto 602-0841, Japan
TEL
075-251-5794
y-noto@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yu-ichi |
| Middle name | |
| Last name | Noto |
Organization
Kyoto prefectural university of medicine hospital
Division name
Department of Neurology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto 602-0841, Japan
TEL
075-251-5794
Homepage URL
y-noto@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural university of medicine
Institute
Department
Personal name
Yuichi Noto
Funding Source
Organization
MHLW Research on rare and intractable diseases Program Grant Number JPMH23FC1008
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
Tel
075-251-5337
rinri@koto.kpu-m.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs052210206
Org. issuing International ID_1
jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Regarding safety, no adverse event associated with the use of the NMES device occurred throughout the present study.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
| 2025 | Year | 10 | Month | 28 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 28 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068509
