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

NCT00108043 | Completed Phase 1

• 1 other identifier: NHMRC 302013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Keywords

Functional Electrical Stimulation; Gait; Blood pressure; Orthostatic Hypotension; Cardiovascular responses; Near-infra red spectroscopy

Outcome Measures

Primary Outcomes (1)

• Change of systolic blood pressure during three FES-evoked stepping conditions

Secondary Outcomes (5)

• Cardiovascular and Metabolic Responses

• Autonomic Responses

• Muscle Metabolic Responses

• Humoral Responses

• Syncope Symptom Score

Interventions

FES-evoked functional upright gait PROCEDURE

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sydney: lead

Study Sites (1)

Rehabilitation Research Centre, University of Sydney

Sydney, New South Wales, 2141, Australia

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Glen M Davis, PhD, FACSM

  University of Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 12, 2005
• First Posted: April 13, 2005
• Study Start: March 1, 2004
• Study Completion: December 1, 2006
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

AU (1)