The Effect of FES on Children With Spinal Cord Injury

NCT00291317 | Completed Results

• 1 other identifier: 5532
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injury

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

RT 300-P FES Cycle

EXPERIMENTAL

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

Interventions

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.

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

RT 300-P FES Cycle

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 4-21
• Paralysis/lack of sensation in lower extremities due to spinal cord injury.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Specialized Hospital: lead
• University of Medicine and Dentistry of New Jersey: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Difficulty for participants to attend sessions. Difficulties with recruitment.

Results Point of Contact

• Title: Frank Castello
• Organization: Children's Specialized Hospital

fcastello@childrens-specialized.org

732 258 7065

Study Officials

• Frank Castello, MD

  Children's Specialized Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: February 10, 2006
• First Posted: February 14, 2006
• Study Start: January 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: January 1, 2011
• Last Updated: August 13, 2012
• Results First Posted: August 13, 2012

Record last verified: 2012-08