Clinical Trials Directory

Trials / Completed

CompletedNCT00291317

The Effect of FES on Children With Spinal Cord Injury

The Effect of FES on Children With Spinal Cord Dysfunction

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Children's Specialized Hospital · Academic / Other
Sex
All
Age
4 Years – 21 Years
Healthy volunteers
Accepted

Summary

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 Spinal Cord Injured (SCI) patients using this bike.

Detailed description

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 (SCI). We plan to examine the effect of FES bike therapy on bone mineral density and psychological well-being.

Conditions

Interventions

TypeNameDescription
DEVICERT 300-P FES CycleParticipants exercised using functional electrical stimulation cycling (FES) using the RT 300-P FES cycle (Restorative Therapies, Baltimore, MD). Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes per session over a 9 month period. The intervention was provided at Children's Specialized Hospital in Mountainside, and families were required to provide their own transportation. During the study, the participants continued to participate in their standard, primary rehabilitation program.

Timeline

Start date
2006-01-01
Primary completion
2008-09-01
Completion
2011-01-01
First posted
2006-02-14
Last updated
2012-08-13
Results posted
2012-08-13

Source: ClinicalTrials.gov record NCT00291317. Inclusion in this directory is not an endorsement.