The Effect of FES on Children With Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT00291317|
Recruitment Status : Completed
First Posted : February 14, 2006
Results First Posted : August 13, 2012
Last Update Posted : August 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Device: RT 300-P FES Cycle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of FES on Children With Spinal Cord Dysfunction|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||January 2011|
Experimental: RT 300-P FES Cycle
Participants exercised using functional electrical stimulation cycling (FES) using the RT 300-P FES cycle (Restorative Therapies, Baltimore, MD).
Device: RT 300-P FES Cycle
Participants 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.
- Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score. [ Time Frame: pre- and post-intervention; time frame among participants ranged from 4 to 12 months ]The PedsQL™ 4.0 is a modular instrument for measuring health-related quality of life in children and adolescents. The questionnaire asks how much of a problem each item has been during the past month, using a 5-point response scale. This study used the Emotional Functioning, Social Functioning, and School Functioning modules. Scores on these three modules are combined to yield a Psychosocial Health Summary Score (range = 0-100 with 100 being the maximum positive outcome). Pre- and post-intervention scores were compared to determine improvement.
- Change in Bone Mineral Density Measured Via DEXA Scan [ Time Frame: At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness) ]Bone mineral density (BMD) was measured with Dual X-ray Absorptiometry (DEXA) scans using a GE LUNAR system. DEXA has been used in patients with loss of ambulation due to SCI to monitor changes in body composition over time and to evaluate the effectiveness of exercise in preventing or reducing the disease-related complications of SCI. It was used in the present study to determine BMD in the right distal femur at baseline; after 3 months of intervention; after 6 months; and for children who biked for the full duration of the study, at the completion of 9 months of intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291317
|Principal Investigator:||Frank Castello, MD||Children's Specialized Hospital|