Functional Electrical Stimulation (FES) Cycling for Children With Spinal Cord Injuries (SCI)

Completed · Not applicable

Conditions studied: Spinal Cord Injury

In brief

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 spinal cord injuries (SCI). To achieve this goal, a controlled, randomized study will be conducted with thirty children who have sustained a spinal cord injury. The children in the study will be assigned to one of three groups: those receiving functional electrical stimulation (FES) leg cycling exercise, those receiving passive leg cycling, and a non-cycling control group receiving electrical stimulation therapy to generate muscle contractions in the lower extremity. All three groups will be balanced as to the amount of time they receive the specific therapy. All therapies, after initial assessment, will be conducted at home in order to foster changes in lifestyle that may prove to be essential for improved quality of life. The specific aims of this proposal are delineated below: Aim 1: To assess, by means of a randomized controlled study design, the ability of FES cycling to improve the cardiovascular and musculoskeletal systems of ten children with a spinal cord injury, as compared to ten children undergoing passive leg cycling exercise and ten children receiving electrical stimulation therapy alone. Aim 2: To determine, by means of a randomized controlled study design, the feasibility of using FES leg cycling exercise to provide long-term health benefits and improve the neurologic status of ten children with a spinal cord injury, as compared to ten children undergoing passive leg cycling exercise and ten children receiving electrical stimulation therapy alone.

Key facts

Study ID

NCT00245726

Run by

Shriners Hospitals for Children

People needed

30

Starts

2004-03-01

Expected to finish

2008-06-01

Last updated by the study team

2009-02-02

Who can join

Age: 5 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Kennedy Krieger Institute — Baltimore, Maryland, United States
• Shriners Hospitals for Children — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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