Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI
NCT ID: NCT01891110
Last Updated: 2014-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2012-03-31
2014-05-31
Brief Summary
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The presence of orthostatic hypotension (OH) as a consequence of blood volume redistribution during verticalisation in persons with spinal cord injury (SCI) is a common condition.
Aims:
To investigate the impact of three different types of electric stimulation (ES) (ES of the abdominal muscles versus ES of lower limb muscles versus simultaneously ES of abdominal and lower limb muscles versus control) on blood pressure stabilization and verticalisation-degrees between 0° and 70°. The hypothesis is, that the ES-induced contractions of the muscles cause a stabilisation respectively an increase of the blood pressure during the tilt-table test.
Subjects:
20 Women and men, at least 18 years of age, following an acute and traumatic SCI, with a lesion level above T6, an American Spinal Injury Association (AIS) Impairment Scale A,B or C and a diagnosis of OH (by tilt table test) were eligible for the study.
Methods:
Each patient underwent randomly three different types of ES sessions while being positioned on a tilt-table. The following sessions were planned:
A) ES of the abdominal muscles B) ES of the lower limb muscles C) Combination of A and B D) Control session (=diagnostic session)
Study type: Intervention Design: Prospective interventional study
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ES of the abdominal muscles
ES with surface electrodes, fixed stimulation parameters and individual mA
ES of the abdominal muscles
ES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility.
ES of limbs & abdomen
The combination of the ES of the lower limb muscles and the abdominal muscles.
ES of limbs & abdomen
The combination of the ES of the lower limb muscles and the abdominal muscles.
ES of the limb muscles
Lower limb muscles were stimulated to produce a milking mechanism from the distal to proximal part of the limb to pump the venous blood from the peripheral to the central part of the body
ES of the limb muscles
Lower limb muscles were stimulated to produce a milking mechanism from the distal to proximal part of the limb to pump the venous blood from the peripheral to the central part of the body
Interventions
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ES of the abdominal muscles
ES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility.
ES of the limb muscles
Lower limb muscles were stimulated to produce a milking mechanism from the distal to proximal part of the limb to pump the venous blood from the peripheral to the central part of the body
ES of limbs & abdomen
The combination of the ES of the lower limb muscles and the abdominal muscles.
Eligibility Criteria
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Inclusion Criteria
* positive diagnosis of OH
* acute traumatic SCI
* lesion level above T6
* AIS A, B or C
Exclusion Criteria
* decubitus (NPUAP \>2)
* massive psychiatric dysfunction
* suicide intention
18 Years
ALL
No
Sponsors
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Swiss Paraplegic Research, Nottwil
NETWORK
Responsible Party
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Principal Investigators
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Aurelio Tobon, MD
Role: PRINCIPAL_INVESTIGATOR
Swiss paraplegic center
Locations
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Swiss Paraplegic Center
Nottwil, Canton of Lucerne, Switzerland
Countries
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Related Links
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Swiss Paraplegic Centre Nottwil
Other Identifiers
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2011-26
Identifier Type: -
Identifier Source: org_study_id
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