Clinical Trial: Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI
Brief 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
Detailed Summary:
Sponsor: Swiss Paraplegic Centre Nottwil
Current Primary Outcome: blood pressure [mmHg] [ Time Frame: 1 day (single measurement at each arm ) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Heart rate [ Time Frame: 1 day (single measurement at each arm ) ]
Original Secondary Outcome: Same as current
Information By: Swiss Paraplegic Centre Nottwil
Dates:
Date Received: June 4, 2013
Date Started: March 2012
Date Completion:
Last Updated: May 13, 2014
Last Verified: May 2014
