The Effect of FES on Children With Spinal Cord Injury

Children's Specialized Hospital

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Device: RT 300-P FES Cycle

Study type: Interventional

Funder types: Other

Identifiers

NCT00291317

5532

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 4 to 21 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

RT 300-P FES Cycle

Experimental group

Description:

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

Treatment:

Device: RT 300-P FES Cycle