NCT00245726

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 2, 2009

Status Verified

January 1, 2009

Enrollment Period

4.3 years

First QC Date

October 27, 2005

Last Update Submit

January 29, 2009

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (10)

  • Muscle Cross Sectional Area

    6 months

  • ES Muscle Strength

    12 months

  • Bone Mineral Density of Hip and Knee

    12 months

  • Cholesterol

    12 months

  • White Blood Cell Count

    12 months

  • Peak Resistive Force

    12 months

  • Ashworth Scale

    12 motnhs

  • Spasm Scale

    12 months

  • Quality of Life (PedsQL)

    12 months

  • ASIA assessment

    12 months

Study Arms (3)

1

ACTIVE COMPARATOR

Passive (Motor Assist) Cycle

Device: Passive (Motor Assist) Cycle

2

ACTIVE COMPARATOR
Device: ES therapy

3

EXPERIMENTAL
Device: FES Cycle

Interventions

FES CycleDEVICE

Subjects will use electrical stimulation of the leg muscles to pedal a cycle for 1 hour / 3x week

3
ES therapyDEVICE

Subjects will electrically stimulate the leg muscles for 1 hour/ 3x week

2
Passive (Motor Assist) CycleDEVICE

Subjects will use a cycle that moves the legs for 1 hour/3x per week

1

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Shriners Hospitals for Children

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (2)

  • 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. doi: 10.1016/j.apmr.2011.06.031.

    PMID: 22133240DERIVED

  • 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. doi: 10.1016/j.apmr.2009.02.018.

    PMID: 19651272DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Richard Lauer, PhD

    Shriners Hospitals for Children

    PRINCIPAL INVESTIGATOR

  • John W McDonald, MD, PhD

    Kennedy Kreiger Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 28, 2005

Study Start

March 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 2, 2009

Record last verified: 2009-01

Locations

US(2)