An observational study in Spinal Cord Injury (SCI), sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 3 Years to 13 Years. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by University of Florida · Observational
The Kids STEP Study aims to
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 7 is below the median of 60 across 323 observational studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children with SCI for whom walking recovery is unlikely
Individuals with SCI will include:
Exclusion Criteria
Children with SCI who -
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
Also known as: body weight supported treadmill training, activity-based therapy
Recovery of walking, assessed in treadmill/ BWS environment and overground
Time frame: pre-training, after 20, 40, and 60 sessions of locomotor training
Amount of daily step activity
Time frame: during and post 60 sessions of locomotor training
Walking independence, WISCI II
Time frame: during and post 60 sessions of locomotor training
Stepping assessment and kinematic analysis
Time frame: Post 20, 40, and 60 sessions of locomotor training
Analysis of locomotor tasks such as crawling, swimming, cycling
Time frame: post 20, 40, and 60 sessions of locomotor training
Self-selected and fast gait speed
Time frame: Pre-training and after 20, 40, 60 sessions (post-LT)
Spinal MRI to assess injury
Time frame: Pre-training
Spinal reflex assessment (H reflex)
Time frame: Pre-training and post-training
Correlation of locomotion recovery and isolated voluntary leg movement (ASIA motor score)
Time frame: Pre-training and post-training
Correlation and assessment of reticulospinal tract (Acoustic startle reflex)with recovery of locomotion
Time frame: Pre-training and post-training
Correlation and assessment of corticospinal tract integrity via transcranial magnetic stimulation
Time frame: Pre-training and post-training
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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