Clinical trial NCT00488280: Restoring Walking in Non-ambulatory Children With Severe Chronic Spinal Cord Injury (SCI) (Kids STEP Study)
Official title: Restoring Walking in Non-ambulatory Children With Severe Chronic SCI (Kids STEP Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury (SCI)
Keywords: walking
walking recovery
physical therapy
locomotor training
body weight support
neuroplasticity
step
treadmill
treadmill training
locomotion
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
name: Brooks Rehabilitation
name: Baylor College of Medicine
First posted: 2007-06-20
Enrollment: 7
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with SCI for whom walking recovery is unlikely

Brief summary: The Kids STEP Study aims to

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

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 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

Children with SCI who -

* Are currently participating in a rehabilitation program or another research protocol that could interfere or influence the outcome measures of the current study
* Have 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

Primary outcomes:
measure: Recovery of walking, assessed in treadmill/ BWS environment and overground
timeFrame: pre-training, after 20, 40, and 60 sessions of locomotor training
Secondary outcomes:
measure: Amount of daily step activity
timeFrame: during and post 60 sessions of locomotor training
measure: Walking independence, WISCI II
timeFrame: during and post 60 sessions of locomotor training
measure: Stepping assessment and kinematic analysis
timeFrame: Post 20, 40, and 60 sessions of locomotor training
measure: Analysis of locomotor tasks such as crawling, swimming, cycling
timeFrame: post 20, 40, and 60 sessions of locomotor training
measure: Self-selected and fast gait speed
timeFrame: Pre-training and after 20, 40, 60 sessions (post-LT)
measure: Spinal MRI to assess injury
timeFrame: Pre-training
measure: Spinal reflex assessment (H reflex)
timeFrame: Pre-training and post-training
measure: Correlation of locomotion recovery and isolated voluntary leg movement (ASIA motor score)
timeFrame: Pre-training and post-training
measure: Correlation and assessment of reticulospinal tract (Acoustic startle reflex)with recovery of locomotion
timeFrame: Pre-training and post-training
measure: Correlation and assessment of corticospinal tract integrity via transcranial magnetic stimulation
timeFrame: Pre-training and post-training
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Andrea L Behrman, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Dena R Howland, PhD, OT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1089/neu.2006.23.571.
citation: 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. doi: 10.1016/s0003-9993(99)90126-0.
citation: 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.
citation: Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
citation: 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. doi: 10.1146/annurev.neuro.27.070203.144308.
citation: 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. doi: 10.2522/ptj.20050212.