N/A
N=6
The Effect of FES on Children With Spinal Cord Injury
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT00291317 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score. — 7.08 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RT 300-P FES Cycle (Device)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Children's Specialized Hospital
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score. |
7.08 | — |
| PRIMARY Change in Bone Mineral Density Measured Via DEXA Scan |
0.062 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 4-21
- Paralysis/lack of sensation in lower extremities due to spinal cord injury.
Exclusion criteria
- Diseases known to affect bone metabolism
- A history of hip or knee dislocation or subluxation
- The presence of pressure sores in the areas of treatment
- The presence of metallic hardware in the femur
- A history of peripheral nerve injury, lower motor neuron disease, or chronic corticosteroid use; or a seizure disorder requiring pharmacological antiepileptic therapy that can affect bone mineral density.
- Individuals with pacemaker devices or unhealed fractures also were excluded.
Data sourced from ClinicalTrials.gov (NCT00291317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.