Functional Electrical Stimulation (FES) Cycling for Children With Spinal Cord Injuries (SCI) - Full Text View

Purpose

The overall objective of this research project is to examine the clinical efficacy of lower extremity cycling with functional electrical stimulation to improve the health and fitness of children with spinal cord injuries (SCI). To achieve this goal, a controlled, randomized study will be conducted with thirty children who have sustained a spinal cord injury. The children in the study will be assigned to one of three groups: those receiving functional electrical stimulation (FES) leg cycling exercise, those receiving passive leg cycling, and a non-cycling control group receiving electrical stimulation therapy to generate muscle contractions in the lower extremity. All three groups will be balanced as to the amount of time they receive the specific therapy. All therapies, after initial assessment, will be conducted at home in order to foster changes in lifestyle that may prove to be essential for improved quality of life.

The specific aims of this proposal are delineated below:

Aim 1: To assess, by means of a randomized controlled study design, the ability of FES cycling to improve the cardiovascular and musculoskeletal systems of ten children with a spinal cord injury, as compared to ten children undergoing passive leg cycling exercise and ten children receiving electrical stimulation therapy alone.

Aim 2: To determine, by means of a randomized controlled study design, the feasibility of using FES leg cycling exercise to provide long-term health benefits and improve the neurologic status of ten children with a spinal cord injury, as compared to ten children undergoing passive leg cycling exercise and ten children receiving electrical stimulation therapy alone.

Condition	Intervention
Spinal Cord Injury	Device: FES Cycle Device: ES therapy Device: Passive (Motor Assist) Cycle

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Lower Extremity Cycling With Functional Electrical Stimulation to Improve the Health and Fitness of Children With Spinal Cord Injuries

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:

Muscle Cross Sectional Area [ Time Frame: 6 months ] [ Designated as safety issue: No ]
ES Muscle Strength [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Bone Mineral Density of Hip and Knee [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Cholesterol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
White Blood Cell Count [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Peak Resistive Force [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Ashworth Scale [ Time Frame: 12 motnhs ] [ Designated as safety issue: No ]
Spasm Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Quality of Life (PedsQL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
ASIA assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	March 2004
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Passive (Motor Assist) Cycle	Device: Passive (Motor Assist) Cycle Subjects will use a cycle that moves the legs for 1 hour/3x per week
Active Comparator: 2	Device: ES therapy Subjects will electrically stimulate the leg muscles for 1 hour/ 3x week
Experimental: 3	Device: FES Cycle Subjects will use electrical stimulation of the leg muscles to pedal a cycle for 1 hour / 3x week

Show Detailed Description

Eligibility

Ages Eligible for Study:	5 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Satisfactory general health
Twelve months post injury to allow for plateau in neurology function, bowel patterns, and cardiovascular patterns
Cervical (tetraplegia) or thoracic (paraplegia) level spinal cord injury (ASIA A and ASIA B classifications)
Intact lower motor neurons of the targeted lower extremity muscles
Skeletally immature (5 to 15 years of age)
Ability to maintain an upright position with minimal support
Adequate time available for trial participation (12 months)

Exclusion Criteria:

Conditions (e.g. arthritis) requiring chronic steroid treatment
Symptomatic or known cardiac disease
Presence of a seizure disorder
Pulmonary disease limiting exercise tolerance
Conflicting implanted devices which may be adversely affected by the electrical stimulation (any implanted medical device, including a cardiac pacemaker or electronic Baclofen pump)
History of lower limb stress fractures
Severe spasticity in legs - score of ³ 4 on the Modified Ashworth scale
Presence of a Grade 2 or higher pressure area on the legs, buttocks, or trunk
Severely limited range of joint motion/irreversible muscle contractures
Ossification of joints in the lower limbs
Hip instability / dislocation
History of uncontrolled autonomic dysreflexia
Previous participant in electrical stimulation or activity based therapy (i.e. cycling, treadmill training) within 3 months of enrollment
Small size of the subject limiting the ability to be safely positioned on the bicycle

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245726

Locations

United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
United States, Pennsylvania
Shriners Hospitals for Children
Philadelphia, Pennsylvania, United States, 19140

Sponsors and Collaborators

Shriners Hospitals for Children

Investigators

Principal Investigator:	Richard Lauer, PhD	Shriners Hospitals for Children
Principal Investigator:	John W McDonald, MD, PhD	Kennedy Kreiger Institute

More Information

No publications provided by Shriners Hospitals for Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Johnston TE, Modlesky CM, Betz RR, Lauer RT. Muscle changes following cycling and/or electrical stimulation in pediatric spinal cord injury. Arch Phys Med Rehabil. 2011 Dec;92(12):1937-43.

Johnston TE, Smith BT, Mulcahey MJ, Betz RR, Lauer RT. A randomized controlled trial on the effects of cycling with and without electrical stimulation on cardiorespiratory and vascular health in children with spinal cord injury. Arch Phys Med Rehabil. 2009 Aug;90(8):1379-88.

Responsible Party:	Richard T. Lauer, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:	NCT00245726 History of Changes
Other Study ID Numbers:	SHC-8540
Study First Received:	October 27, 2005
Last Updated:	January 29, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases

Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013