Status:
COMPLETED
Functional Electrical Stimulation (FES) Cycling for Children With Spinal Cord Injuries (SCI)
Lead Sponsor:
Shriners Hospitals for Children
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
5-15 years
Phase:
NA
Brief Summary
The overall objective of this research project is to examine the clinical efficacy of lower extremity cycling with functional electrical stimulation to improve the health and fitness of children with ...
Detailed Description
This is a controlled, randomized pretest/posttest study design in which three conditions will be compared: FES leg cycling exercise, passive leg cycling exercise, and a control group receiving electri...
Eligibility Criteria
Inclusion
- Satisfactory general health
- Twelve months post injury to allow for plateau in neurology function, bowel patterns, and cardiovascular patterns
- Cervical (tetraplegia) or thoracic (paraplegia) level spinal cord injury (ASIA A and ASIA B classifications)
- Intact lower motor neurons of the targeted lower extremity muscles
- Skeletally immature (5 to 15 years of age)
- Ability to maintain an upright position with minimal support
- Adequate time available for trial participation (12 months)
Exclusion
- Conditions (e.g. arthritis) requiring chronic steroid treatment
- Symptomatic or known cardiac disease
- Presence of a seizure disorder
- Pulmonary disease limiting exercise tolerance
- Conflicting implanted devices which may be adversely affected by the electrical stimulation (any implanted medical device, including a cardiac pacemaker or electronic Baclofen pump)
- History of lower limb stress fractures
- Severe spasticity in legs - score of ³ 4 on the Modified Ashworth scale
- Presence of a Grade 2 or higher pressure area on the legs, buttocks, or trunk
- Severely limited range of joint motion/irreversible muscle contractures
- Ossification of joints in the lower limbs
- Hip instability / dislocation
- History of uncontrolled autonomic dysreflexia
- Previous participant in electrical stimulation or activity based therapy (i.e. cycling, treadmill training) within 3 months of enrollment
- Small size of the subject limiting the ability to be safely positioned on the bicycle
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00245726
Start Date
March 1 2004
End Date
June 1 2008
Last Update
February 2 2009
Active Locations (2)
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1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
2
Shriners Hospitals for Children
Philadelphia, Pennsylvania, United States, 19140