Functional Electrical Stimulation (FES) Cycling for Children With Spinal Cord Injuries (SCI)
Spinal Cord Injury
About this trial
This is an interventional treatment trial for Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Kennedy Krieger Institute
- Shriners Hospitals for Children
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Experimental
1
2
3
Passive (Motor Assist) Cycle