Status:
TERMINATED
Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury
Lead Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
This research is being done to study the effect of Functional Electrical Stimulation (FES) cycling on factors in blood and spinal cord in people with spinal cord injury (SCI).
Detailed Description
FES cycling is a method of applying low level electrical currents to the leg and buttock muscles to cause the weakened or paralyzed muscles to contract and produce a cycling motion of the legs. The FE...
Eligibility Criteria
Inclusion
- History of traumatic spinal cord injury sustained at least 6 months prior
- Complete spinal cord injury at any level American Spinal Injury Association (ASIA) impairment scale A
- No use of functional electrical stimulation within 3 months
- Medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
- Legally able to make own health care decisions
Exclusion
- Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke, history of arrhythmia with hemodynamic instability
- Uncontrolled hypertension (resting systolic blood pressure (BP) \>160mmHg or diastolic BP \>100mmHg consistently)
- Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability
- Unstable long bone fractures of the lower extremities
- Subjects who are unwilling to agree to two (2) CSF examinations (lumbar punctures)
- Presence of cardiac pacemaker and/or defibrillator
- Presence of cancer
- History of epileptic seizures
- Subjects having a Stage 2 or greater sacral decubitus ulcer
- Women who are pregnant
- Active drug or alcohol use or dependence
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01217047
Start Date
October 1 2010
End Date
August 1 2013
Last Update
January 27 2021
Active Locations (1)
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1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205