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

Restoring Walking in Non-ambulatory Children With Severe Chronic 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

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury (SCI)
• Intervention / Treatment: Behavioral: Locomotor Training

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; activity-based therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Amount of daily step activity	during and post 60 sessions of locomotor training
Walking independence, WISCI II	during and post 60 sessions of locomotor training
Stepping assessment and kinematic analysis	Post 20, 40, and 60 sessions of locomotor training
Analysis of locomotor tasks such as crawling, swimming, cycling	post 20, 40, and 60 sessions of locomotor training
Self-selected and fast gait speed	Pre-training and after 20, 40, 60 sessions (post-LT)
Spinal MRI to assess injury	Pre-training
Spinal reflex assessment (H reflex)	Pre-training and post-training
Correlation of locomotion recovery and isolated voluntary leg movement (ASIA motor score)	Pre-training and post-training
Correlation and assessment of reticulospinal tract (Acoustic startle reflex)with recovery of locomotion	Pre-training and post-training
Correlation and assessment of corticospinal tract integrity via transcranial magnetic stimulation	Pre-training and post-training

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Baylor College of Medicine; The Craig H. Neilsen Foundation; Brooks Rehabilitation
• Investigators: Principal Investigator: Andrea L Behrman, PhD, PT, University of Florida; Principal Investigator: Dena R Howland, PhD, OT, University of Florida

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 19, 2007
• First Submitted That Met QC Criteria: June 19, 2007
• First Posted (Estimate): June 20, 2007

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 7, 2013
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: neuroplasticity; walking; physical therapy; treadmill; locomotion; locomotor training; treadmill training; body weight support; walking recovery; step
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 313-2006