UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020341 |
|---|---|
| Receipt number | 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 22:23:36 |
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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
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
tbonezjp@yahoo.co.jp
Sponsor or person
Institute
Natinal Hospital Organization Murayama Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023145
| 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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| Registered date | File name |
