Retraining Walking After Spinal Cord Injury
|ClinicalTrials.gov Identifier: NCT00059553|
Recruitment Status : Unknown
Verified August 2005 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Active, not recruiting
First Posted : April 29, 2003
Last Update Posted : June 18, 2009
|First Submitted Date ICMJE||April 28, 2003|
|First Posted Date ICMJE||April 29, 2003|
|Last Update Posted Date||June 18, 2009|
|Study Start Date ICMJE||May 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00059553 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Retraining Walking After Spinal Cord Injury|
|Official Title ICMJE||Activity-Dependent Plasticity After Spinal Cord Injury|
|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.|
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Behavioral: Locomotor treadmill training with body weight support|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||January 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||6 Years to 65 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00059553|
|Other Study ID Numbers ICMJE||K01HD001348( U.S. NIH Grant/Contract )|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Collaborators ICMJE||VA Office of Research and Development|
|PRS Account||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Verification Date||August 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP