Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01891110
Enrollment
20
Registered
2013-07-02
Start date
2012-03-31
Completion date
2014-05-31
Last updated
2014-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthostatic Hypotension, Spinal Cord Injury

Keywords

electric stimulation, tilt-table

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

Interventions

PROCEDUREES of the abdominal muscles

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

PROCEDUREES 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

PROCEDUREES of limbs & abdomen

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

Sponsors

Swiss Paraplegic Research, Nottwil
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Heart rate1 day (single measurement at each arm )

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026