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| Sponsored by: |
University of Sydney |
|---|---|
| Information provided by: | University of Sydney |
| ClinicalTrials.gov Identifier: | NCT00108043 |
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 I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Orthostatic Tolerance During FES-Evoked Stepping in Paraplegia: A Safety and Viability Study |
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | December 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Glen M Davis, PhD, FACSM | University of Sydney |
More Information
| Study ID Numbers: | NHMRC 302013 |
| Study First Received: | April 12, 2005 |
| Last Updated: | July 11, 2006 |
| ClinicalTrials.gov Identifier: | NCT00108043 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Functional Electrical Stimulation Gait Blood pressure |
Orthostatic Hypotension Cardiovascular responses Near-infra red spectroscopy |
|
Hypotension Hypotension, Orthostatic Spinal Cord Diseases Paraplegia Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin |
Trauma, Nervous System Paralysis Spinal Cord Injuries Signs and Symptoms Postural hypotension Neurologic Manifestations |
|
Nervous System Diseases |
