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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00488280
Enrollment
7
Registered
2007-06-20
Start date
2007-02-28
Completion date
2012-09-30
Last updated
2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury (SCI)

Keywords

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

Brief 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

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.

Interventions

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

Sponsors

The Craig H. Neilsen Foundation
CollaboratorOTHER
Brooks Rehabilitation
CollaboratorOTHER
Baylor College of Medicine
CollaboratorOTHER
University of Florida
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Recovery of walking, assessed in treadmill/ BWS environment and overgroundpre-training, after 20, 40, and 60 sessions of locomotor training

Secondary

MeasureTime frame
Amount of daily step activityduring and post 60 sessions of locomotor training
Walking independence, WISCI IIduring and post 60 sessions of locomotor training
Stepping assessment and kinematic analysisPost 20, 40, and 60 sessions of locomotor training
Analysis of locomotor tasks such as crawling, swimming, cyclingpost 20, 40, and 60 sessions of locomotor training
Correlation and assessment of reticulospinal tract (Acoustic startle reflex)with recovery of locomotionPre-training and post-training
Spinal MRI to assess injuryPre-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 corticospinal tract integrity via transcranial magnetic stimulationPre-training and post-training
Self-selected and fast gait speedPre-training and after 20, 40, 60 sessions (post-LT)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026