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

Swiss Paraplegic Research, Nottwil

Status: Completed

Conditions: Spinal Cord Injury; Orthostatic Hypotension

Treatments: Procedure: ES of limbs & abdomen; Procedure: ES of the limb muscles; Procedure: ES of the abdominal muscles

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01891110

2011-26

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

ES of the abdominal muscles

Experimental group

Description:

ES with surface electrodes, fixed stimulation parameters and individual mA

Treatment:

Procedure: ES of the abdominal muscles

ES of limbs & abdomen

Experimental group

Description:

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

Treatment:

Procedure: ES of limbs & abdomen

ES of the limb muscles

Experimental group

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

Treatment:

Procedure: ES of the limb muscles