UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of functional electrical stimulation for orthostatic hypotension due to spinal cord injury
Title of the study (Brief title)	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	Osamu Uemura
Organization	Natinal Hospital Organization Murayama Medical Center
Division name	Rehabilitation Medicine
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	Osamu Uemura
Organization	Natinal Hospital Organization Murayama Medical Center
Division name	Rehabilitation Medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023145