Skip to main content
OpenTrials
Completed

NCT Number: NCT00488280

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Locomotor Training

Behavioral

Task-specific practice of walking with assistance from trainers using body weight support and treadmill followed by training over ground, 5x/week, approximately 1.5 hours/day

Other names: body weight supported treadmill training, activity-based therapy

Primary outcomes

  1. Recovery of walking, assessed in treadmill/ BWS environment and overground

    Time frame: pre-training, after 20, 40, and 60 sessions of locomotor training

Secondary outcomes

  1. Amount of daily step activity

    Time frame: during and post 60 sessions of locomotor training

  2. Walking independence, WISCI II

    Time frame: during and post 60 sessions of locomotor training

  3. Stepping assessment and kinematic analysis

    Time frame: Post 20, 40, and 60 sessions of locomotor training

  4. Analysis of locomotor tasks such as crawling, swimming, cycling

    Time frame: post 20, 40, and 60 sessions of locomotor training

  5. Self-selected and fast gait speed

    Time frame: Pre-training and after 20, 40, 60 sessions (post-LT)

  6. Spinal MRI to assess injury

    Time frame: Pre-training

  7. Spinal reflex assessment (H reflex)

    Time frame: Pre-training and post-training

  8. Correlation of locomotion recovery and isolated voluntary leg movement (ASIA motor score)

    Time frame: Pre-training and post-training

  9. Correlation and assessment of reticulospinal tract (Acoustic startle reflex)with recovery of locomotion

    Time frame: Pre-training and post-training

  10. Correlation and assessment of corticospinal tract integrity via transcranial magnetic stimulation

    Time frame: Pre-training and post-training

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Baylor College of Medicine
  • Brooks Rehabilitation
  • The Craig H. Neilsen Foundation

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2007
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.