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

Sponsor

Swiss Paraplegic Centre Nottwil (Other)

Overall Status

Completed

CT.gov ID

NCT01891110

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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:

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

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury Orthostatic Hypotension	Procedure: ES of the abdominal muscles Procedure: ES of the limb muscles Procedure: ES of limbs & abdomen	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ES of the abdominal muscles ES with surface electrodes, fixed stimulation parameters and individual mA	Procedure: ES of the abdominal muscles ES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility.
Experimental: ES of limbs & abdomen The combination of the ES of the lower limb muscles and the abdominal muscles.	Procedure: ES of limbs & abdomen The combination of the ES of the lower limb muscles and the abdominal muscles.
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	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

Arm

Intervention/Treatment

Experimental: ES of the abdominal muscles

ES with surface electrodes, fixed stimulation parameters and individual mA

Procedure: ES of the abdominal muscles

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

Experimental: ES of limbs & abdomen

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

Procedure: ES of limbs & abdomen

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

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

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

Outcome Measures

Primary Outcome Measures

blood pressure [mmHg] [1 day (single measurement at each arm )]

Secondary Outcome Measures

Heart rate [1 day (single measurement at each arm )]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Swiss Paraplegic Center	Nottwil	Luzern	Switzerland	6207

Sponsors and Collaborators

Swiss Paraplegic Centre Nottwil

Investigators

Principal Investigator: Aurelio Tobon, MD, Swiss paraplegic center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Swiss Paraplegic Centre Nottwil

Publications

None provided.

Responsible Party:

Swiss Paraplegic Centre Nottwil

ClinicalTrials.gov Identifier:

NCT01891110

Other Study ID Numbers:

2011-26

First Posted:

Jul 2, 2013

Last Update Posted:

May 14, 2014

Last Verified:

May 1, 2014

Keywords provided by Swiss Paraplegic Centre Nottwil

electric stimulation

tilt-table

Additional relevant MeSH terms:

Spinal Cord Injuries

Hypotension, Orthostatic

Hypotension

Study Results

No Results Posted as of May 14, 2014