The Effect of FES on Children With Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

The Effect of FES on Children With Spinal Cord Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291317
• Other study ID #: 5532
• Status: Completed
• Phase: N/A
• First received: February 10, 2006
• Last updated: August 10, 2012
• Start date: January 2006
• Est. completion date: January 2011

Study information

• Verified date: August 2012
• Source: Children's Specialized Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00374816

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2011
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 21 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Specialized Hospital	University of Medicine and Dentistry of New Jersey

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score.	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.	pre- and post-intervention; time frame among participants ranged from 4 to 12 months	No
Primary	Change in Bone Mineral Density Measured Via DEXA Scan	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.	At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness)	No