UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045085 |
|---|---|
| Receipt number | R000051500 |
| Scientific Title | Neurophysiological effects of a high-speed neuromotor exercise protocol on females with Multiple Sclerosis: a randomized controlled trial. |
| Date of disclosure of the study information | 2021/08/06 |
| Last modified on | 2021/08/06 16:54:36 |
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Basic information
Public title
Comparison of the effect of 8 weeks of CoDuSe training in water and on land on the fatigue, balance and physical disability in women with Multiple Sclerosis.
Acronym
Comparison of the effect of 8 weeks of CoDuSe training in water and on land on the fatigue, balance and physical disability in women with Multiple Sclerosis.
Scientific Title
Neurophysiological effects of a high-speed neuromotor exercise protocol on females with Multiple Sclerosis: a randomized controlled trial.
Scientific Title:Acronym
Neurophysiological effects of a high-speed neuromotor exercise protocol on females with Multiple Sclerosis: a randomized controlled trial.
Region
| Asia(except Japan) |
Condition
Condition
Female adults with multiple sclerosis
Classification by specialty
| Medicine in general | Neurology | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effects of a high-speed NeuroMotor resistance training on nerve conductivity and balance in women with MS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical neurophysiology and Functional test.
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 program of a high-speed NeuroMotor exercises, consisting of 18 sessions, limited to 80 minutes each.
Interventions/Control_2
No intervention for six weeks
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
| 35 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
1-having normal vision, hearing and dexterity, lack of personal background of mental and any other neurological disorders other than MS, and confirmed multiple sclerosis for MS via EDSS (1-4); 2-lack of substance abuse and main medical problems; 3- adult women between 35 and 50 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.
Key exclusion criteria
Any participant not complying with the inclusion criteria is excluded from the research process.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Mostafa |
| Middle name | |
| Last name | Sarabzadeh |
Organization
National Elites Foundation, Tehran, Iran
Division name
Exercise Physiology and NeuroPhysiotherapy
Zip code
09821
Address
No. 209, between Navab and Roudaki St., Azadi street, Tehran
TEL
0989376293463
m.sarabzadeh89@mailfa.com
Public contact
Name of contact person
| 1st name | Mostafa |
| Middle name | |
| Last name | Sarabzadeh |
Organization
National Elites Foundation, Tehran, Iran
Division name
Exercise Physiology and NeuroPhysiotherapy
Zip code
09821
Address
No. 209, between Navab and Roudaki St., Azadi street, Tehran
TEL
0989376293463
Homepage URL
m.sarabzadeh89@mailfa.com
Sponsor or person
Institute
Department of Sports Injuries and Corrective Exercises, Faculty of Sports Sciences, Karaj Azad University, Karaj, Iran.
Institute
Department
Personal name
Funding Source
Organization
Department of Sports Injuries and Corrective Exercises, Faculty of Sports Sciences, Karaj Azad University, Karaj, Iran.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Iranian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Sports Injuries and Corrective Exercises, Faculty of Sports Sciences, Karaj Azad University, Karaj, Iran.
Address
Imam Ali Complex, Moazen Blvd, Karaj,Alborz, Iran
Tel
09834259571-9
info@kiau.ac.ir
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
| 2021 | Year | 08 | Month | 06 | 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
16
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
| 2020 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 06 | Day |
Last modified on
| 2021 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051500
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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