UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046935 |
|---|---|
| Receipt number | R000053549 |
| 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. |
| Date of disclosure of the study information | 2022/02/24 |
| Last modified on | 2022/02/17 19:26:54 |
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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
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
m.sarabzadeh89@mailfa.com
Sponsor or person
Institute
Nothing to declare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053549
