The Effect of FES on Children With Spinal Cord Injury

NCT ID: NCT00291317

Last Updated: 2012-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2011-01-31

Brief 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.

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.

Conditions

Spinal Cord Injury

Keywords

pediatric spinal cord injury; FES cycling; bone mineral density; quality of life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RT 300-P FES Cycle

Participants exercised using functional electrical stimulation cycling (FES) using the RT 300-P FES cycle (Restorative Therapies, Baltimore, MD).

Group Type: EXPERIMENTAL

RT 300-P FES Cycle

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

FES (Functional electrical stimulation) cycling using th RT 300-P FES cycle; (Restorative Therapies, Baltimore, MD).

Eligibility 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: collaborator

Children's Specialized Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Frank Castello

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Castello, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Specialized Hospital

Countries

United States

Other Identifiers

5532

Identifier Type: -

Identifier Source: org_study_id

NCT00374816

Identifier Type: -

Identifier Source: nct_alias