The Effect of FES on Children With Spinal Cord Dysfunction

This study is ongoing, but not recruiting participants.

First Received: September 8, 2006 Last Updated: April 4, 2007 History of Changes

Sponsored by:	Children's Specialized Hospital
Information provided by:	Children's Specialized Hospital
ClinicalTrials.gov Identifier:	NCT00374816

Purpose

The study is being done to see if children who cannot walk because of spinal cord damage will be helped by a functional electrical stimulator (FES) cycle ergometer exercise program. It is know that children who are unable to walk bbecause of spinal cord damage experience decreased muscle mass and bone mineral density over time. This puts them at risk for bone fractures, especially of the lower leg. Through this exercise program we are hoping to see improvement in your child's muscle mass, bone mineral density and pyschological well being.

Condition	Intervention
Spinal Cord Children Functional Electrical Stimulation	Device: fes ergometer

MedlinePlus related topics: Minerals

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Functional Electrical Stimulation on Children With Spinal Cord Dysfunction

Further study details as provided by Children's Specialized Hospital:

Primary Outcome Measures:

Bone mineral density in distal femur
Psychological well being

Secondary Outcome Measures:

Endurance

Estimated Enrollment:	18
Study Start Date:	September 2005
Estimated Study Completion Date:	September 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	4 Years to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Spinal cord dysfunction, age 4-19 years, paraplegia

Exclusion Criteria:

femur fracture, inability to tolerate FES,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374816

Locations

United States, New Jersey
Children's Specialized Hospital
Mountainside, New Jersey, United States, 07092

Sponsors and Collaborators

Children's Specialized Hospital

Investigators

Principal Investigator:

Frank V Castello, MD

University of Medicine and Dentistry New Jersey

More Information

No publications provided

Study ID Numbers:	05-3050-SCR-E-0
Study First Received:	September 8, 2006
Last Updated:	April 4, 2007
ClinicalTrials.gov Identifier:	NCT00374816 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Specialized Hospital:

functional electrical stimulation

ClinicalTrials.gov processed this record on May 07, 2009