Spinal Cord Injury Clinical Trial
Official title:
Lower Extremity Cycling With Functional Electrical Stimulation to Improve the Health and Fitness of Children With Spinal Cord Injuries
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years to 15 Years |
Eligibility |
Inclusion Criteria: 1. Satisfactory general health 2. Twelve months post injury to allow for plateau in neurology function, bowel patterns, and cardiovascular patterns 3. Cervical (tetraplegia) or thoracic (paraplegia) level spinal cord injury (ASIA A and ASIA B classifications) 4. Intact lower motor neurons of the targeted lower extremity muscles 5. Skeletally immature (5 to 15 years of age) 6. Ability to maintain an upright position with minimal support 7. Adequate time available for trial participation (12 months) Exclusion Criteria: 1. Conditions (e.g. arthritis) requiring chronic steroid treatment 2. Symptomatic or known cardiac disease 3. Presence of a seizure disorder 4. Pulmonary disease limiting exercise tolerance 5. Conflicting implanted devices which may be adversely affected by the electrical stimulation (any implanted medical device, including a cardiac pacemaker or electronic Baclofen pump) 6. History of lower limb stress fractures 7. Severe spasticity in legs - score of ³ 4 on the Modified Ashworth scale 8. Presence of a Grade 2 or higher pressure area on the legs, buttocks, or trunk 9. Severely limited range of joint motion/irreversible muscle contractures 10. Ossification of joints in the lower limbs 11. Hip instability / dislocation 12. History of uncontrolled autonomic dysreflexia 13. Previous participant in electrical stimulation or activity based therapy (i.e. cycling, treadmill training) within 3 months of enrollment 14. Small size of the subject limiting the ability to be safely positioned on the bicycle |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Kennedy Krieger Institute | Baltimore | Maryland |
United States | Shriners Hospitals for Children | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Shriners Hospitals for Children |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle Cross Sectional Area | 6 months | No | |
Primary | ES Muscle Strength | 12 months | No | |
Primary | Bone Mineral Density of Hip and Knee | 12 months | No | |
Primary | Cholesterol | 12 months | No | |
Primary | White Blood Cell Count | 12 months | No | |
Primary | Peak Resistive Force | 12 months | No | |
Primary | Ashworth Scale | 12 motnhs | No | |
Primary | Spasm Scale | 12 months | No | |
Primary | Quality of Life (PedsQL) | 12 months | No | |
Primary | ASIA assessment | 12 months | No |
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