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The Effect of FES on Children With Spinal Cord Injury

This study has been completed.
Sponsor:
Collaborator:
University of Medicine and Dentistry of 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
  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:
  • FES (Functional electrical stimulation) cycling using th RT 300-P FES cycle
  • (Restorative Therapies, Baltimore, MD).

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291317

Sponsors and Collaborators
Children's Specialized Hospital
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Frank Castello, MD Children's Specialized Hospital
  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
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014