University of Florida
Gainesville, Florida, 32610, United States
NCT Number: NCT00488280
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
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Notify Me3 year–13 year
All sexes
Observational
Gainesville, Florida, 32610, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Individuals with SCI will include:
Exclusion criteria
Children with SCI who -
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
Time frame: pre-training, after 20, 40, and 60 sessions of locomotor training
Time frame: during and post 60 sessions of locomotor training
Time frame: during and post 60 sessions of locomotor training
Time frame: Post 20, 40, and 60 sessions of locomotor training
Time frame: post 20, 40, and 60 sessions of locomotor training
Time frame: Pre-training and after 20, 40, 60 sessions (post-LT)
Time frame: Pre-training
Time frame: Pre-training and post-training
Time frame: Pre-training and post-training
Time frame: Pre-training and post-training
Time frame: Pre-training and post-training
University of Florida
Other
Restoring Walking in Non-ambulatory Children With Severe Chronic SCI (Kids STEP Study)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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