Status:
COMPLETED
The Effects of Two Functional Electrical Stimulation Cycling Paradigms
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
The Craig H. Neilsen Foundation
Magee Rehabilitation Hospital
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Background: People with spinal cord injury (SCI) are at risk for many health conditions, some of which can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one way ...
Eligibility Criteria
Inclusion
- Cervical or thoracic SCI of greater than 6 months duration
- American Spinal Injury Association Impairment Scale (AIS) levels A (motor and sensory complete) or B (motor complete)
- Intact lower motor neurons to the quadriceps, hamstrings, and gluteal muscles
Exclusion
- History of renal or bladder stones or renal impairment
- Presence of conditions that require chronic steroids
- Symptomatic or known cardiac disease
- Pulmonary disease limiting exercise tolerance
- Ventilator dependency
- Implanted devices that may be adversely affected by the FES system
- Lower extremity fragility fractures in the previous 3 months
- Severe spasticity in legs
- Presence of a Grade 2 or higher pressure ulcer
- Severely limited range of joint motion
- Heterotopic ossification of joints in the lower extremities
- Uncontrolled autonomic dysreflexia
- Dislocation of one or both hips
- Pregnancy or plans to become pregnant during the study
- Post menopausal, if female
- Current seizure disorder
- Participation in activities involving electrical stimulation or activity based therapy within the past 3 months
- Participation in a neuroregenerative intervention within the past 12 months
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01244594
Start Date
July 1 2010
End Date
October 1 2013
Last Update
January 8 2014
Active Locations (3)
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1
Magee Rehabilitation Hospital
Philadelphia, Pennsylvania, United States, 19102
2
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
3
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107