Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059553
Status:
UNKNOWN
Last Update Posted:
2009-06-18
First Post:
2003-04-28
Brief Title:
Retraining Walking After Spinal Cord Injury
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Activity-Dependent Plasticity After Spinal Cord Injury
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Incomplete spinal cord injury often results in difficulty walking Training on a treadmill with body weight support may improve walking ability after spinal cord injury The purpose of this study is to examine the effect of treadmill speed on spinal cord function and walking performance
Detailed Description:
Conventional rehabilitation following spinal cord injury SCI emphasizes functional gains through strengthening and compensation using braces and assistive devices to achieve mobility Rehabilitation practice using compensatory approaches is based on the prevailing assumption that neural recovery is not possible following SCI
Recent evidence contradicts this assumption Stimulated by the proper activation of peripheral afferents associated with walking neuronal circuits may reorganize by strengthening of existing and previously inactive descending connections and local neural circuits New approaches to locomotor recovery after SCI utilize sensory information related to locomotion to improve treadmill and overground walking
Locomotor training velocity may be a critical task-specific and activity-dependent parameter affording appropriate phasic afferent input to the neural system and promoting neural plasticity The purpose of this study is to evaluate the effects of training velocity in a long-term locomotor training program on both neurophysiological and behavioral plasticity in individuals with incomplete SCI
Sixteen patients with incomplete SCI will be recruited to participate in this study Baseline evaluations will include American Spinal Injury Association classification rate-sensitive depression phase-dependent H-reflex modulation at self-selected and fast overground walking velocities and MRI of the spine Patients will wear a step activity monitor for a 48-hour period quantifying baseline walking activity level
All patients will participate in a locomotor training program Patients will be randomly assigned to either training at self-selected treadmill velocity or at a normal walking velocity Patients will have 45 training sessions over 9 weeks Each training session will include 30 minutes of walking Interim testing of rated depression spatial-temporal parameters of walking MRI and walking activity will occur through the 9-week training period Post-testing will occur within 2 days of the last training session and at a 1 month after completion of the training During the month following long-term training patients will be instructed to return to their self-selected routine activities of daily living
Recent evidence contradicts this assumption Stimulated by the proper activation of peripheral afferents associated with walking neuronal circuits may reorganize by strengthening of existing and previously inactive descending connections and local neural circuits New approaches to locomotor recovery after SCI utilize sensory information related to locomotion to improve treadmill and overground walking
Locomotor training velocity may be a critical task-specific and activity-dependent parameter affording appropriate phasic afferent input to the neural system and promoting neural plasticity The purpose of this study is to evaluate the effects of training velocity in a long-term locomotor training program on both neurophysiological and behavioral plasticity in individuals with incomplete SCI
Sixteen patients with incomplete SCI will be recruited to participate in this study Baseline evaluations will include American Spinal Injury Association classification rate-sensitive depression phase-dependent H-reflex modulation at self-selected and fast overground walking velocities and MRI of the spine Patients will wear a step activity monitor for a 48-hour period quantifying baseline walking activity level
All patients will participate in a locomotor training program Patients will be randomly assigned to either training at self-selected treadmill velocity or at a normal walking velocity Patients will have 45 training sessions over 9 weeks Each training session will include 30 minutes of walking Interim testing of rated depression spatial-temporal parameters of walking MRI and walking activity will occur through the 9-week training period Post-testing will occur within 2 days of the last training session and at a 1 month after completion of the training During the month following long-term training patients will be instructed to return to their self-selected routine activities of daily living
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