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Completed

NCT Number: NCT01891110

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

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

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Key information

Conditions

Spinal Cord Injury Autonomic Nervous System Diseases Cardiovascular Diseases Central Nervous System Diseases Hypotension Hypotension, Orthostatic Nervous System Diseases Orthostatic Hypotension Orthostatic Intolerance Primary Dysautonomias Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Paraplegic Center

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ES of the abdominal muscles

Procedure

ES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility.

ES of the limb muscles

Procedure

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

Procedure

The combination of the ES of the lower limb muscles and the abdominal muscles.

Primary outcomes

  1. blood pressure [mmHg]

    Time frame: 1 day (single measurement at each arm )

Secondary outcomes

  1. Heart rate

    Time frame: 1 day (single measurement at each arm )

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 2, 2013
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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