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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041303
Receipt No. R000046457
Scientific Title Safety and efficacy of lower limb Neuromuscular Electrical Stimulation in persons with acute spinal cord injury
Date of disclosure of the study information 2020/10/01
Last modified on 2021/02/03

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Basic information
Public title Safety and efficacy of lower limb Neuromuscular Electrical Stimulation in persons with acute spinal cord injury
Acronym Safety and efficacy of lower limb Neuromuscular Electrical Stimulation in persons with acute spinal cord injury
Scientific Title Safety and efficacy of lower limb Neuromuscular Electrical Stimulation in persons with acute spinal cord injury
Scientific Title:Acronym Safety and efficacy of lower limb Neuromuscular Electrical Stimulation in persons with acute spinal cord injury
Region
Japan

Condition
Condition Patients with spinal cord injury
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the this study is the immediate effect of the Neuromuscular Electrical Stimulation in patients with acute spinal cord injury
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The measurements of the quadriceps thickness at 1 and 3 weeks post-injury
Key secondary outcomes The measurements of the quadriceps muscle strength and walking ability at 1 and 3 weeks post-injury

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Standard Physical Therapy and Neuromuscular Electrical Stimulation (2 weeks, 5 days a week, 40 minutes a day, 50 Hz, 300 s, 20-50 mA)
Interventions/Control_2 Standard Physical Therapy
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with AIS C and D incomplete cervical spinal cord injuries admitted within 1 day of injury
Key exclusion criteria If you have a pelvic or femoral fracture, If complications affecting muscle strength are observed, If adverse events are observed along the way
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yusuke
Middle name
Last name Morooka
Organization Saitama Medical University Faculty of Health
Division name Department of Physical Therapy
Zip code 350-0496
Address Moroyama-cho Iruma-gun, Saitama 981 Kawakado
TEL 049-295-1001
Email morooka@saitama-med.ac.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Morooka
Organization Saitama Medical University Faculty of Health
Division name Department of Physical Therapy
Zip code 350-0496
Address Moroyama-cho Iruma-gun, Saitama 981 Kawakado
TEL 049-295-1001
Homepage URL
Email morooka@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Faculty of Health
Institute
Department

Funding Source
Organization Saitama Medical University Faculty of Health
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committee of Saitama Medical Center
Address Kawagoe, Saitama 1981 Kamoda
Tel 049-228-3902
Email smcrinri@saitama-med.ac.jp

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
2020 Year 10 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
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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 01 Day
Date of IRB
2021 Year 01 Month 07 Day
Anticipated trial start date
2021 Year 03 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 04 Day
Last modified on
2021 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046457

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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