NCT01891110

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Swiss Paraplegic Research, Nottwil · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Spinal Cord Injury
• Orthostatic Hypotension

Interventions

Type	Name	Description
PROCEDURE	ES of the abdominal muscles	ES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility.
PROCEDURE	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
PROCEDURE	ES of limbs & abdomen	The combination of the ES of the lower limb muscles and the abdominal muscles.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-07-02
• Last updated: 2014-05-14

Locations

1 site across 1 country: Switzerland