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

Spinal Cord Injury (SCI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488280
• Other study ID #: 313-2006
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2007
• Last updated: January 7, 2013
• Start date: February 2007
• Est. completion date: September 2012

Study information

• Verified date: January 2010
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 13 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury (SCI)

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	Brooks Center for Rehabilitation Studies, Texas Children's Hospital, The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

References & Publications (6)

Barbeau H, Ladouceur M, Norman KE, Pépin A, Leroux A. Walking after spinal cord injury: evaluation, treatment, and functional recovery. Arch Phys Med Rehabil. 1999 Feb;80(2):225-35. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of walking, assessed in treadmill/ BWS environment and overground		pre-training, after 20, 40, and 60 sessions of locomotor training	No
Secondary	Amount of daily step activity		during and post 60 sessions of locomotor training	No
Secondary	Walking independence, WISCI II		during and post 60 sessions of locomotor training	Yes
Secondary	Stepping assessment and kinematic analysis		Post 20, 40, and 60 sessions of locomotor training	Yes
Secondary	Analysis of locomotor tasks such as crawling, swimming, cycling		post 20, 40, and 60 sessions of locomotor training	No
Secondary	Self-selected and fast gait speed		Pre-training and after 20, 40, 60 sessions (post-LT)	No
Secondary	Spinal MRI to assess injury		Pre-training	No
Secondary	Spinal reflex assessment (H reflex)		Pre-training and post-training	No
Secondary	Correlation of locomotion recovery and isolated voluntary leg movement (ASIA motor score)		Pre-training and post-training	No
Secondary	Correlation and assessment of reticulospinal tract (Acoustic startle reflex)with recovery of locomotion		Pre-training and post-training	No
Secondary	Correlation and assessment of corticospinal tract integrity via transcranial magnetic stimulation		Pre-training and post-training	No