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

Spinal Cord Injury Clinical Trial

Official title:

Orthostatic Tolerance During FES-evoked Stepping in Paraplegia: A Safety and Viability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108043
• Other study ID #: NHMRC 302013
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2005
• Last updated: December 2, 2015
• Start date: March 2004
• Est. completion date: December 2006

Study information

• Verified date: December 2015
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Paraplegia
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Procedure:
• FES-evoked functional upright gait

Locations

Country	Name	City	State
Australia	Rehabilitation Research Centre, University of Sydney	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of systolic blood pressure during three FES-evoked stepping conditions
Secondary	Cardiovascular and Metabolic Responses
Secondary	Autonomic Responses
Secondary	Muscle Metabolic Responses
Secondary	Humoral Responses
Secondary	Syncope Symptom Score