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

Primary Purpose

Spinal Cord Injury, Orthostatic Hypotension

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ES of the abdominal muscles
ES of the limb muscles
ES of limbs & abdomen
Sponsored by
Swiss Paraplegic Research, Nottwil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring electric stimulation, tilt-table

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Swiss Paraplegic Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ES of the abdominal muscles

ES of limbs & abdomen

ES of the limb muscles

Arm Description

ES with surface electrodes, fixed stimulation parameters and individual mA

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

Outcomes

Primary Outcome Measures

blood pressure [mmHg]

Secondary Outcome Measures

Heart rate

Full Information

First Posted
June 4, 2013
Last Updated
May 13, 2014
Sponsor
Swiss Paraplegic Research, Nottwil
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1. Study Identification

Unique Protocol Identification Number
NCT01891110
Brief Title
Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI
Official Title
Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Paraplegic Research, Nottwil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Orthostatic Hypotension
Keywords
electric stimulation, tilt-table

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ES of the abdominal muscles
Arm Type
Experimental
Arm Description
ES with surface electrodes, fixed stimulation parameters and individual mA
Arm Title
ES of limbs & abdomen
Arm Type
Experimental
Arm Description
The combination of the ES of the lower limb muscles and the abdominal muscles.
Arm Title
ES of the limb muscles
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
ES of the abdominal muscles
Intervention Description
ES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility.
Intervention Type
Procedure
Intervention Name(s)
ES of the limb muscles
Intervention Description
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 Type
Procedure
Intervention Name(s)
ES of limbs & abdomen
Intervention Description
The combination of the ES of the lower limb muscles and the abdominal muscles.
Primary Outcome Measure Information:
Title
blood pressure [mmHg]
Time Frame
1 day (single measurement at each arm )
Secondary Outcome Measure Information:
Title
Heart rate
Time Frame
1 day (single measurement at each arm )

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurelio Tobon, MD
Organizational Affiliation
Swiss paraplegic center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Paraplegic Center
City
Nottwil
State/Province
Luzern
ZIP/Postal Code
6207
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.paraplegie.ch
Description
Swiss Paraplegic Centre Nottwil

Learn more about this trial

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

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