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

NCT00488280 | Completed

• 1 other identifier: 313-2006
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The Kids STEP Study aims to

1. 1.Determine if walking can be restored in children with incomplete SCI and little to no leg movement
2. 2.Identify the neural pathways that permit recovery of walking

Conditions

Spinal Cord Injury (SCI)

Keywords

walking; walking recovery; physical therapy; locomotor training; body weight support; neuroplasticity; step; treadmill; treadmill training; locomotion

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (10)

• 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)

Study Arms (1)

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

Interventions

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

Also known as: body weight supported treadmill training, activity-based therapy

Kids Step Study: Locomotor Training

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with SCI for whom walking recovery is unlikely

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• The Craig H. Neilsen Foundation: collaborator
• Brooks Rehabilitation: collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (7)

• 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.

  PMID: 16629638 BACKGROUND

• 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.

  PMID: 10025502 BACKGROUND

• 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.

  PMID: 16305274 BACKGROUND

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

  PMID: 10869131 BACKGROUND

• 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.

  PMID: 15217329 BACKGROUND

• 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.

  PMID: 17012645 BACKGROUND

• Howland DR, Trimble SA, Fox EJ, Tester NJ, Spiess MR, Senesac CR, Kleim JA, Spierre LZ, Rose DK, Johns JS, Ugiliweneza B, Reier PJ, Behrman AL. Recovery of walking in nonambulatory children with chronic spinal cord injuries: Case series. J Neurosci Res. 2023 Jun;101(6):826-842. doi: 10.1002/jnr.25162. Epub 2023 Jan 23.

  PMID: 36690607 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Andrea L Behrman, PhD, PT

  University of Florida

  PRINCIPAL INVESTIGATOR

• Dena R Howland, PhD, OT

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 20, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

US (1)