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| Sponsored by: |
Children's Specialized Hospital |
|---|---|
| Information provided by: | Children's Specialized Hospital |
| ClinicalTrials.gov Identifier: | NCT00291317 |
Purpose
Regular exercise is strongly recommended to help maintain a healthy lifestyle. Unfortunately, children and young adults with damaged spinal cords may not be able to exercise regularly. However, there is an exercise bike specially designed for persons with damaged spinal cords that enables them to pedal by directly stimulating the muscles in their legs. Our study is designed to determine the benefits of exercise for SCI-patients using this bike.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury |
Device: ERGYS-2 Device: RS300s |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | The Effect of FES on Children With Spinal Cord Dysfunction |
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | September 2007 |
The inability to walk due to spinal cord dysfunction has profound effects on patients, both physiologically and psychologically. Complications associated with walking upright include loss of muscle mass from atrophy, reduction in bone mineral density (osteoporosis), compromised cardiovascular endurance, loss of sense of well-being, etc. Functional Electrical Stimulation (FES) of the lower extremities has been found to reverse many of these complications. We propose to examine the use of FES in children who have suffered from spinal cord injury. We plan to examine the effect of FES bike therapy on muscle mass and bone mineral density, cardiorespiratory function, and psychological well-being.
Eligibility| Ages Eligible for Study: | 4 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contacts and Locations| United States, New Jersey | |
| Children's Specialized Hospital | |
| Mountainside, New Jersey, United States, 08903 | |
| Principal Investigator: | Frank Castello, PhD | Children's Specialized Hospital |
More Information
| Study ID Numbers: | 5532 |
| Study First Received: | February 10, 2006 |
| Last Updated: | April 4, 2007 |
| ClinicalTrials.gov Identifier: | NCT00291317 |
| Health Authority: | United States: Institutional Review Board |
|
Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
|
Nervous System Diseases |
