Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488280
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2007-06-19
Brief Title:
Restoring Walking in Non-ambulatory Children With Severe Chronic Spinal Cord Injury SCI Kids STEP Study
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Restoring Walking in Non-ambulatory Children With Severe Chronic SCI Kids STEP Study
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 systems 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 childs 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 childs 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
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 childs 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 childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None