Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI

Study Overview
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Brief Summary
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Background: 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

Official Title
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Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI

Conditions
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Spinal Cord Injury, Orthostatic Hypotension

Intervention / Treatment
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* Procedure: ES of the abdominal muscles
* Procedure: ES of the limb muscles
* Procedure: ES of limbs & abdomen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: inpatients positive diagnosis of OH acute traumatic SCI lesion level above T6 AIS A, B or C Exclusion Criteria: fractures of the lower limbs decubitus (NPUAP >2) massive psychiatric dysfunction suicide intention

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ES of the abdominal muscles<br>ES with surface electrodes, fixed stimulation parameters and individual mA | Procedure: ES of the abdominal muscles<br>* ES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility.<br>|
| Experimental: ES of limbs & abdomen<br>The combination of the ES of the lower limb muscles and the abdominal muscles. | Procedure: ES of limbs & abdomen<br>* The combination of the ES of the lower limb muscles and the abdominal muscles.<br>|
| Experimental: ES of the limb muscles<br>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 | Procedure: ES of the limb muscles<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure [mmHg] |  | 1 day (single measurement at each arm ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | 1 day (single measurement at each arm ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electric stimulation, tilt-table