The Effect of FES on Children With Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

4 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RT 300-P FES Cycle

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.

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

Primary outcomes

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

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)

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.

Sponsors and collaborators

Lead sponsor

Children's Specialized Hospital

Other

Collaborators

University of Medicine and Dentistry of New Jersey

Registry information

Official study title

The Effect of FES on Children With Spinal Cord Dysfunction

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2011
First posted: Feb 14, 2006
Registry last updated: Aug 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed