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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00488280
• Date of registration: 19/06/2007
• Prospective Registration: No
• Primary sponsor: University of Florida
• Public title: Restoring Walking in Non-ambulatory Children With Severe Chronic Spinal Cord Injury (SCI) (Kids STEP Study)
• Scientific title: Restoring Walking in Non-ambulatory Children With Severe Chronic SCI (Kids STEP Study)
• Date of first enrolment: February 2007
• Target sample size: 7
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00488280
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Dena R Howland, PhD, OT
• Affiliation: University of Florida

• Name: Andrea L Behrman, PhD, PT
• Affiliation: University of Florida

Key inclusion & exclusion 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



Age minimum: 3 Years
Age maximum: 13 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Spinal Cord Injury (SCI)

Intervention(s)

Behavioral: Locomotor Training

Primary Outcome(s)

Recovery of walking, assessed in treadmill/ BWS environment and overground [Time Frame: pre-training, after 20, 40, and 60 sessions of locomotor training]

Secondary Outcome(s)

Analysis of locomotor tasks such as crawling, swimming, cycling [Time Frame: post 20, 40, and 60 sessions of locomotor training]

Correlation of locomotion recovery and isolated voluntary leg movement (ASIA motor score) [Time Frame: Pre-training and post-training]

Amount of daily step activity [Time Frame: during and post 60 sessions of locomotor training]

Walking independence, WISCI II [Time Frame: during and post 60 sessions of locomotor training]

Correlation and assessment of reticulospinal tract (Acoustic startle reflex)with recovery of locomotion [Time Frame: Pre-training and post-training]

Spinal MRI to assess injury [Time Frame: Pre-training]

Spinal reflex assessment (H reflex) [Time Frame: Pre-training and post-training]

Self-selected and fast gait speed [Time Frame: Pre-training and after 20, 40, 60 sessions (post-LT)]

Correlation and assessment of corticospinal tract integrity via transcranial magnetic stimulation [Time Frame: Pre-training and post-training]

Stepping assessment and kinematic analysis [Time Frame: Post 20, 40, and 60 sessions of locomotor training]

Secondary ID(s)

313-2006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Brooks Center for Rehabilitation Studies

The Craig H. Neilsen Foundation

Texas Children's Hospital