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

This study has been completed.
Sponsor:
Collaborators:
The Craig H. Neilsen Foundation
Brooks Center for Rehabilitation Studies
Texas Children's Hospital
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00488280
First received: June 19, 2007
Last updated: January 7, 2013
Last verified: January 2010
  Purpose

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

Condition Intervention Phase
Spinal Cord Injury (SCI)
Behavioral: Locomotor Training
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Restoring Walking in Non-ambulatory Children With Severe Chronic SCI (Kids STEP Study)

Resource links provided by NLM:


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 ]

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 ]
  • Self-selected and fast gait speed [ Time Frame: Pre-training and after 20, 40, 60 sessions (post-LT) ] [ Designated as safety issue: No ]
  • Spinal MRI to assess injury [ Time Frame: Pre-training ] [ Designated as safety issue: No ]
  • Spinal reflex assessment (H reflex) [ Time Frame: Pre-training and post-training ] [ Designated as safety issue: No ]
  • Correlation of locomotion recovery and isolated voluntary leg movement (ASIA motor score) [ Time Frame: Pre-training and post-training ] [ Designated as safety issue: No ]
  • Correlation and assessment of reticulospinal tract (Acoustic startle reflex)with recovery of locomotion [ Time Frame: Pre-training and post-training ] [ Designated as safety issue: No ]
  • Correlation and assessment of corticospinal tract integrity via transcranial magnetic stimulation [ Time Frame: Pre-training and post-training ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: February 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kids Step Study: Locomotor Training
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
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
  • locomotor training
  • activity-based therapy

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
The 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

Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00488280     History of Changes
Other Study ID Numbers: 313-2006
Study First Received: June 19, 2007
Last Updated: January 7, 2013
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
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014