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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier:
NCT01891110
First received: June 4, 2013
Last updated: May 13, 2014
Last verified: May 2014

June 4, 2013
May 13, 2014
March 2012
May 2014   (final data collection date for primary outcome measure)
blood pressure [mmHg] [ Time Frame: 1 day (single measurement at each arm ) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01891110 on ClinicalTrials.gov Archive Site
Heart rate [ Time Frame: 1 day (single measurement at each arm ) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI
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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Spinal Cord Injury
  • Orthostatic Hypotension
  • 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.
  • Experimental: ES of the abdominal muscles
    ES with surface electrodes, fixed stimulation parameters and individual mA
    Intervention: Procedure: ES of the abdominal muscles
  • Experimental: ES of limbs & abdomen
    The combination of the ES of the lower limb muscles and the abdominal muscles.
    Intervention: Procedure: ES of limbs & abdomen
  • Experimental: 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
    Intervention: Procedure: ES of the limb muscles
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01891110
2011-26
No
Swiss Paraplegic Centre Nottwil
Swiss Paraplegic Centre Nottwil
Not Provided
Principal Investigator: Aurelio Tobon, MD Swiss paraplegic center
Swiss Paraplegic Centre Nottwil
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP