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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020341
Receipt No. R000023145
Scientific Title Effect of functional electrical stimulation for orthostatic hypotension due to spinal cord injury
Date of disclosure of the study information 2016/01/01
Last modified on 2017/12/26

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Basic information
Public title Effect of functional electrical stimulation for orthostatic hypotension due to spinal cord injury
Acronym Effect of functional electrical stimulation for orthostatic hypotension due to spinal cord injury
Scientific Title Effect of functional electrical stimulation for orthostatic hypotension due to spinal cord injury
Scientific Title:Acronym Effect of functional electrical stimulation for orthostatic hypotension due to spinal cord injury
Region
Japan

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

Objectives
Narrative objectives1 To examine the effectiveness of the functional electrical stimulation to lower extremities and tilting maneuvers for 2 weeks improve orthostatic hypotension (OH) in people with SCI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure, heart rate, Perceived presyncope score (PPS), and maximal tolerable angle of tilt.
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
Maneuver
Interventions/Control_1 tilting maneuvers without FES
tilting maneuvers with FES
30 minutes training / day,
5 days / week, for 2 weeks

Interventions/Control_2 tilting maneuvers without FES
30 minutes training / day,
5 days / week, for 2 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inpatients with spinal cord injury who have OH.
Expected to stay at hospital over 2 weeks.
Prescribed tilting maneuvers training for OH.
Neurological level is at Th6 or above.
Time since injury is more than a month.
Having no recent history of cardiac problems (including pace maker), or evidence of autonomic dysreflexia, or deep venous thronbosis.
Having cognitive level enough to understand the aim of this study and cooperate with training and recording.
Obracining informed consent.
Key exclusion criteria Not matching inclusion criteria
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Uemura
Organization Natinal Hospital Organization Murayama Medical Center
Division name Rehabilitation Medicine
Zip code
Address 2-37-1, Gakuen, Musashimurayama-shi, Tokyo, 208-0011, Japan
TEL 042-561-1221
Email tbonezjp@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Uemura
Organization Natinal Hospital Organization Murayama Medical Center
Division name Rehabilitation Medicine
Zip code
Address 2-37-1, Gakuen, Musashimurayama-shi, Tokyo, 208-0011, Japan
TEL 042-561-1221
Homepage URL
Email tbonezjp@yahoo.co.jp

Sponsor
Institute Natinal Hospital Organization Murayama Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 01 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 Terminated
Date of protocol fixation
2015 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 25 Day
Last modified on
2017 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023145

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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