UMIN-CTR Clinical Trial

Basic information
Public title	Electroneuromyography comparison between pre-elderly adults with and without MS; the potential role of a home-based exercise therapy in improving neurophysiological profile of MS during pandemic.
Acronym	Electroneuromyography comparison between pre-elderly adults with and without MS; the potential role of a home-based exercise therapy in improving neurophysiological profile of MS during pandemic.
Scientific Title	Electroneuromyography comparison between pre-elderly adults with and without MS; the potential role of a home-based exercise therapy in improving neurophysiological profile of MS during pandemic.
Scientific Title:Acronym	Electroneuromyography comparison between pre-elderly adults with and without MS; the potential role of a home-based exercise therapy in improving neurophysiological profile of MS during pandemic.
Region	Asia(except Japan)

Condition
Condition	Adults with multiple sclerosis
Classification by specialty	Medicine in general Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Imagined isometric contraction as a therapy in multiple sclerosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Neurophysiological assessments
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Treatment
Type of intervention	Other
Interventions/Control_1	Six-week imaginary exercise intervention
Interventions/Control_2	No intervention for six-week
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	50 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1-having normal vision, hearing and dexterity, lack of personal background of mental and neurological disorders for control group, and confirmed multiple sclerosis for MS group via EDSS (1-4); 2-lack of substance abuse and main medical problems; 3-adult women between 50 and 65 years of age; 4-written agreement with the research processes; 5-having minimum elementary education; and 6-having physical and cognitive ability confirmed through documentation on their medical records, and interest in participating in the intervention program.
Key exclusion criteria	Any participant not complying with these inclusion criteria was excluded from the research process
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Mostafa Middle name Last name Sarabzadeh
Organization	Aja University of Medical Sciences
Division name	Exercise Physiology and NeuroPhysiotherapy
Zip code	611/14185
Address	Aja University of medical science, Kargar shomali, Sakhaei st
TEL	0989376293463
Email	m.sarabzadeh89@mailfa.com

Public contact
Name of contact person	1st name Mostafa Middle name Last name Sarabzadeh
Organization	Aja University of Medical Sciences
Division name	Exercise Physiology and NeuroPhysiotherapy
Zip code	611/14185
Address	Aja University of medical science, Kargar shomali, Sakhaei st
TEL	0989376293463
Homepage URL
Email	m.sarabzadeh89@mailfa.com

Sponsor
Institute	Nothing to declare
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Young Researchers and Elite Club, Islamic Azad University, Iran.
Address	Razavi Khorasan Province, Mashhad, Kuy-e-Honar, Ostad Yousefi Blvd
Tel	09851 3663 0781
Email	m.sarabzadeh89@mailfa.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 24 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	30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 04 Month 10 Day
Date of IRB	2019 Year 01 Month 01 Day
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2021 Year 12 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 02 Month 17 Day
Last modified on	2022 Year 02 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053549