Restoring Walking in Non-ambulatory Children With Severe Chronic Spinal Cord Injury (SCI) (Kids STEP Study) - Full Text View

Sponsor:	University of Florida
Collaborators:	Craig H. Neilsen Foundation Brooks Center for Rehabilitation Studies Texas Children's Hospital
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00488280

Purpose

The Kids STEP Study aims to

Determine if walking can be restored in children with incomplete SCI and little to no leg movement
Identify the neural pathways that permit recovery of walking

Condition	Intervention	Phase
Spinal Cord Injury (SCI) Incomplete Spinal Cord Injury	Behavioral: Locomotor training with a treadmill and body weight support	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Restoring Walking in Non-ambulatory Children With Severe Chronic SCI (Kids STEP Study)

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

Recovery of walking, assessed in treadmill/ BWS environment and overground [ Time Frame: pre-training, after 20, 40, and 60 sessions of locomotor training ] [ Designated as safety issue: No ]
self-selected and fast gait speeds [ Time Frame: pre-training, after 20, 40, and 60 sessions of locomotor training ] [ Designated as safety issue: No ]
Correlation of locomotion recovery and isolated voluntary leg movement (ASIA motor score) [ Time Frame: pre-training, after 20, 40, and 60 sessions of locomotor training ] [ Designated as safety issue: No ]
Assessment of corticospinal tract integrity via Transcranial Magnetic Stimulation (TMS) [ Time Frame: Pre training and after 20, 40, 60 sessions of locomotor training ] [ Designated as safety issue: No ]
Assessment of reticulospinal tract (Acoustic startle reflex) [ Time Frame: Pre training ] [ Designated as safety issue: No ]
Spinal reflex assessment (H reflex) [ Time Frame: pre-training, after 20, 40, and 60 sessions of locomotor training ] [ Designated as safety issue: No ]
Brain and/ or Spinal MRI to assess injury [ Time Frame: Pre training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Amount of daily step activity [ Time Frame: during and post 60 sessions of locomotor training ] [ Designated as safety issue: No ]
Walking independence, WISCI II [ Time Frame: during and post 60 sessions of locomotor training ] [ Designated as safety issue: Yes ]
Stepping assessment and kinematic analysis [ Time Frame: Post 20, 40, and 60 sessions of locomotor training ] [ Designated as safety issue: Yes ]
Analysis of locomotor tasks such as crawling, swimming, cycling [ Time Frame: post 20, 40, and 60 sessions of locomotor training ] [ Designated as safety issue: No ]

Estimated Enrollment:	6
Study Start Date:	February 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
KSS: Experimental All children who participate will be in the experimental cohort, KSS-#, and receive 60 sessions of daily locomotor training. This experimental cohort will also undergo clinical and neurophysiological testing pre, during, and post 60 sessions of locomotor training.	Behavioral: Locomotor training with a treadmill and body weight support Locomotor training on a treadmill with body weight support will be conducted daily for 60 sessions (5x/week).

Detailed Description:

Locomotor training (LT) is an activity-based therapy to promote plasticity and recovery of walking. It is based on animal studies investigating walking recovery after spinal cord injury and the nervous system's control of walking. Normal walking is achieved through the interaction of multiple levels of the neural axis (cortex, brain stem, spinal cord). However, a basic rhythmic walking pattern is generated by central pattern generators (CPGs) located within the spinal cord. Investigations of central pattern generators indicate that sensory input specific to the task of walking can enhance the firing of these spinal neuronal centers. Thus, LT is an intensive walking program designed to provide sensory input to the spinal cord so that the neural output from the spinal CPGs can be maximized. In addition, LT uses a treadmill and a harness to provide partial body weight support enabling persons with injury to repetitively practice walking in a safe, enabling environment.

Children enrolled in the study (after medical clearance and consent to participate) will undergo extensive testing and complete 12 weeks of locomotor training. Testing will examine the child's neurologic and functional status. Tests to examine functional status include: ASIA evaluation of sensory and motor function, gait analysis, comprehensive strength tests, and assessment of skills such as cycling, stepping, and kicking. Tests to examine the child's neurologic injury include: MRI, Transcranial Magnetic Stimulation (TMS), and reflex testing. Locomotor training will be conducted daily (5 days/ week) for a total of 60 sessions over 12 weeks. During training children will work closely with therapists, researcher, and trainers to practice walking skills on the treadmill and over-ground.

Eligibility

Ages Eligible for Study:	3 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Individuals with SCI will include:

Pre-adolescent children, ages 3-13 yrs old
A diagnosis of first time, non-progressive SCI, upper motor neuron lesion, including, but not limited to, etiology from trauma, inflammation, vascular, surgical re-section due to localized tumor removal or orthopedic pathology resulting in clinical signs of lower cervical or thoracic spinal cord injury
Non-ambulatory or impaired ambulation for greater than 1 yr, such that physical assistance and the use of assistive devices (i.e. walker) and/or leg braces (i.e. knee- ankle- foot orthoses (KAFOs)) are required to ambulate
A SCI as defined by the American Spinal Injury Association (ASIA) Impairment Scale category B or C
A medically stable condition that is asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with testing of walking function and training or alter compliance with a training protocol
Documented medical approval from the participant's personal physician verifying the participant's medical status
Parent's informed consent for children

Exclusion Criteria

Post-SCI children will be:

Is currently participating in a rehabilitation program or another research protocol that could interfere or influence the outcome measures of the current study
Has a history of congenital SCI (e.g. Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration or syringomyelia) that may complicate the treatment and/or evaluation procedures
Children who are diabetic or have implants, pacemakers, or devices which are not NMR/MRI compatible and are not suitable for the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488280

Locations

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

Craig H. Neilsen Foundation

Brooks Center for Rehabilitation Studies

Texas Children's Hospital

Investigators

Principal Investigator:	Andrea L Behrman, PhD, PT	University of Florida
Principal Investigator:	Dena R Howland, PhD, OT	University of Florida

More Information

Additional Information:

Click here for more information about the Kids STEP Study This link exits the ClinicalTrials.gov site

Publications:

Barbeau H, Nadeau S, Garneau C. Physical determinants, emerging concepts, and training approaches in gait of individuals with spinal cord injury. J Neurotrauma. 2006 Mar-Apr;23(3-4):571-85. Review.

Barbeau H, Ladouceur M, Norman KE, Pepin A, Leroux A. Walking after spinal cord injury: evaluation, treatment, and functional recovery. Arch Phys Med Rehabil. 1999 Feb;80(2):225-35. Review.

Behrman AL, Lawless-Dixon AR, Davis SB, Bowden MG, Nair P, Phadke C, Hannold EM, Plummer P, Harkema SJ. Locomotor training progression and outcomes after incomplete spinal cord injury. Phys Ther. 2005 Dec;85(12):1356-71.

Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700. Review.

Edgerton VR, Tillakaratne NJ, Bigbee AJ, de Leon RD, Roy RR. Plasticity of the spinal neural circuitry after injury. Annu Rev Neurosci. 2004;27:145-67. Review.

Behrman AL, Bowden MG, Nair PM. Neuroplasticity after spinal cord injury and training: an emerging paradigm shift in rehabilitation and walking recovery. Phys Ther. 2006 Oct;86(10):1406-25. Review.

Responsible Party:	University of Florida, Department of Physical Therapy ( Andrea L. Behrman, PhD, PT--Princial Investigator )
Study ID Numbers:	313-2006
Study First Received:	June 19, 2007
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00488280 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

walking
walking recovery
physical therapy
locomotor training
body weight support

neuroplasticity
step
treadmill
treadmill training
locomotion

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Nervous System Diseases
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on February 08, 2010