The Effect of FES on Children With Spinal Cord Injury
This study has been completed.
Sponsor:
Children's Specialized Hospital
Collaborator:
University of Medicine and Dentistry New Jersey
Information provided by (Responsible Party):
Dr. Frank Castello, Children's Specialized Hospital
ClinicalTrials.gov Identifier:
NCT00291317
First received: February 10, 2006
Last updated: August 10, 2012
Last verified: August 2012
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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 Spinal Cord Injured (SCI) patients using this bike.
| Condition | Intervention |
|---|---|
|
Spinal Cord Injury |
Device: RT 300-P FES Cycle |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of FES on Children With Spinal Cord Dysfunction |
Resource links provided by NLM:
Further study details as provided by Children's Specialized Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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.
| Enrollment: | 6 |
| Study Start Date: | January 2006 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 4 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Frank Castello, Medical Director, Children's Specialized Hospital |
| ClinicalTrials.gov Identifier: | NCT00291317 History of Changes |
| Obsolete Identifiers: | NCT00374816 |
| Other Study ID Numbers: | 5532 |
| Study First Received: | February 10, 2006 |
| Results First Received: | June 21, 2011 |
| Last Updated: | August 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Specialized Hospital:
|
pediatric spinal cord injury FES cycling bone mineral density quality of life |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on June 13, 2013