Orthostatic Tolerance During FES (Functional Electrical Stimulation)-Walking in Paraplegia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2005 by University of Sydney.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00108043
First received: April 12, 2005
Last updated: July 11, 2006
Last verified: April 2005
  Purpose

Objective:

The objective of this research is to undertake a safety and viability study of FES-evoked stepping in individuals with paraplegia. The rationale for this objective is based upon the need to clarify whether physiological limitations, especially orthostatic intolerance, limit functional mobility outcomes. The cardiovascular, autonomic, and muscle metabolic factors governing orthostatic tolerance during skin-surface FES stepping will be investigated, since this functional task forms the basis of upright mobility and engenders strong physiological challenges upon key regulatory processes in the SCI (spinal cord injury) patient.

Specific Hypotheses:

i. Reduction of blood pressure will be greater during FES-evoked stepping than during passive stepping; ii. Reduction of blood pressure will be greater during FES-evoked stepping with no upper body component versus FES-stepping with an upper body component; iii. Blood pressure will be reduced even further during FES-evoked stepping following a 6-week progressive-intensity gait training intervention.


Condition Intervention Phase
Spinal Cord Injury
Procedure: FES-evoked functional upright gait
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Orthostatic Tolerance During FES-Evoked Stepping in Paraplegia: A Safety and Viability Study

Resource links provided by NLM:


Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • Change of systolic blood pressure during three FES-evoked stepping conditions

Secondary Outcome Measures:
  • Cardiovascular and Metabolic Responses
  • Autonomic Responses
  • Muscle Metabolic Responses
  • Humoral Responses
  • Syncope Symptom Score

Estimated Enrollment: 10
Study Start Date: March 2004
Estimated Study Completion Date: December 2006
Detailed Description:

Aims:

The primary aim of the safety and viability study is to assess changes in blood pressure during up to 60-min of FES-evoked stepping versus up to 60-min of stepping.

A secondary aim is to investigate changes in blood pressure during FES-assisted stepping with and without a voluntary upper-limb component of gait.

Specific Hypotheses:

i. Reduction of blood pressure will be greater during FES-evoked stepping than during passive stepping; ii. Reduction of blood pressure will be greater during FES-evoked stepping with no upper body component versus FES-stepping with an upper body component; iii. Blood pressure will be reduced even further during FES-evoked stepping following a 6-week progressive-intensity gait training intervention.

Primary Outcome: The primary outcome measure for this study is the change of systolic blood pressure during three FES-evoked stepping conditions, as described below. Each condition is defined as up to 60-min of continuous gait.

Secondary Outcomes: Secondary outcomes include a change of diastolic blood pressure and the duration of orthostatic tolerance. Orthostatic tolerance will be assessed as the time that the subject can perform stepping before the onset of orthostatic hypotension. The duration of orthostatic tolerance will be determined by the time at which one of the following occur: (i) 60 continuous minutes of stepping; or (ii) orthostatic hypotension, defined as a reduction in systolic blood pressure of > 20 mmHg or diastolic blood pressure of >10 mmHg; or (iii) signs and symptoms of pre-syncope; or (iii) upon subject request. Throughout each trial, heart rate and blood pressure will be monitored continuously. In addition to the primary and secondary outcome variables, several additional measurements that may contribute to orthostatic tolerance, or indeed, intolerance, will be assessed at 10-min intervals during stepping.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • A spinal cord lesion, of traumatic etiology, between the 6th and 11th thoracic spinal segments
  • Sensory and motor complete lesion (ASIA [American Spinal Injury Association]-A)
  • At least 2 years post injury
  • Between 18-55 years of age
  • Responsive to electrical stimulation

Exclusion Criteria:

  • Severe osteoporosis, fractures, dislocations (as determined by X-ray and DEXA)
  • Upper limb or shoulder pathologies
  • Severe spasticity (≥4 on Ashworth scale)
  • Contractures
  • Currently undertaking FES or gait training
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108043

Locations
Australia, New South Wales
Rehabilitation Research Centre, University of Sydney Recruiting
Sydney, New South Wales, Australia, 2141
Contact: Glen M Davis, PhD, FACSM    +61 2 9351 9466    g.davis@fhs.usyd.edu.au   
Principal Investigator: Glen M Davis, PhD         
Sub-Investigator: Jack Crosbie, PhD         
Sub-Investigator: James W Middleton, PhD         
Sub-Investigator: Jacquelene Raymond, PhD         
Sponsors and Collaborators
University of Sydney
Investigators
Principal Investigator: Glen M Davis, PhD, FACSM University of Sydney
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00108043     History of Changes
Other Study ID Numbers: NHMRC 302013
Study First Received: April 12, 2005
Last Updated: July 11, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Sydney:
Functional Electrical Stimulation
Gait
Blood pressure
Orthostatic Hypotension
Cardiovascular responses
Near-infra red spectroscopy

Additional relevant MeSH terms:
Paraplegia
Spinal Cord Injuries
Wounds and Injuries
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 24, 2014