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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000045085
Receipt No. 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

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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
Email 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
Email m.sarabzadeh89@mailfa.com

Sponsor
Institute Department of Sports Injuries and Corrective Exercises, Faculty of Sports Sciences, Karaj Azad University, Karaj, Iran.
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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