NCT01891110

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 2, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

June 4, 2013

Last Update Submit

May 13, 2014

Conditions

Spinal Cord InjuryOrthostatic Hypotension

Keywords

electric stimulationtilt-table

Outcome Measures

Primary Outcomes (1)

  • blood pressure [mmHg]

    1 day (single measurement at each arm )

Secondary Outcomes (1)

  • Heart rate

    1 day (single measurement at each arm )

Study Arms (3)

ES of the abdominal muscles

EXPERIMENTAL

ES with surface electrodes, fixed stimulation parameters and individual mA

Procedure: ES of the abdominal muscles

ES of limbs & abdomen

EXPERIMENTAL

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

Procedure: ES of limbs & abdomen

ES of the limb muscles

EXPERIMENTAL

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

Interventions

ES of the abdominal musclesPROCEDURE

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

ES of the abdominal muscles
ES of the limb musclesPROCEDURE

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

ES of the limb muscles
ES of limbs & abdomenPROCEDURE

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

ES of limbs & abdomen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • inpatients
  • positive diagnosis of OH
  • acute traumatic SCI
  • lesion level above T6
  • AIS A, B or C

You may not qualify if:

  • fractures of the lower limbs
  • decubitus (NPUAP \>2)
  • massive psychiatric dysfunction
  • suicide intention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Center

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesHypotension, Orthostatic

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesOrthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Aurelio Tobon, MD

    Swiss paraplegic center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2013

First Posted

July 2, 2013

Study Start

March 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

CH(1)