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

Not Applicable

Completed

• Conditions: Spinal Cord Injury; Orthostatic Hypotension
• Interventions: Procedure: ES of the abdominal muscles; Procedure: ES of limbs & abdomen; Procedure: ES of the limb muscles

• Registration Number: NCT01891110
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-02
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ES of the abdominal muscles	ES of the abdominal muscles	ES with surface electrodes, fixed stimulation parameters and individual mA
ES of limbs & abdomen	ES of limbs & abdomen	The combination of the ES of the lower limb muscles and the abdominal muscles.
ES of the limb muscles	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Heart rate	1 day (single measurement at each arm )

Trial Locations

Locations (1)

Swiss Paraplegic Center; 🇨🇭 Nottwil, Luzern, Switzerland