The Effect of FES on Children With Spinal Cord Injury

The Effect of FES on Children With Spinal Cord Dysfunction

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: RT 300-P FES Cycle

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score.	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.	pre- and post-intervention; time frame among participants ranged from 4 to 12 months
Change in Bone Mineral Density Measured Via DEXA Scan	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.	At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness)

Collaborators and Investigators

• Sponsor: Children's Specialized Hospital
• Collaborators: University of Medicine and Dentistry of New Jersey
• Investigators: Principal Investigator: Frank Castello, MD, Children's Specialized Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: February 10, 2006
• First Submitted That Met QC Criteria: February 10, 2006
• First Posted (Estimate): February 14, 2006

Study Record Updates

• Last Update Posted (Estimate): August 13, 2012
• Last Update Submitted That Met QC Criteria: August 10, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: quality of life; bone mineral density; pediatric spinal cord injury; FES cycling
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 5532