An interventional study of ES of the abdominal muscles and ES of the limb muscles in Spinal Cord Injury and Orthostatic Hypotension, sponsored by Swiss Paraplegic Research, Nottwil. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-14.
Sponsored by Swiss Paraplegic Research, Nottwil · Not applicable, Interventional, and Treatment
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
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 20 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Swiss Paraplegic Research, Nottwil is the lead sponsor of 69 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ES with surface electrodes, fixed stimulation parameters and individual mA
Procedure: ES of the abdominal muscles
The combination of the ES of the lower limb muscles and the abdominal muscles.
Procedure: ES of limbs & abdomen
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
ES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility.
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
The combination of the ES of the lower limb muscles and the abdominal muscles.
blood pressure [mmHg]
Time frame: 1 day (single measurement at each arm )
Heart rate
Time frame: 1 day (single measurement at each arm )
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Swiss Paraplegic Research, Nottwil