Mental Practice Impact on Gait and Cortical Organization in Spinal Cord Injury (SCI)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 22, 2011 |
| Last Updated Date | February 23, 2011 |
| Start Date ICMJE | September 2008 |
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Gait velocity: The investigators are measuring the speed that people walk. [ Time Frame: 1-3 weeks before intervention; 1 week after intervention; 3 months after intervention ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01302522 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 |
| Descriptive Information | |
| Brief Title ICMJE | Mental Practice Impact on Gait and Cortical Organization in Spinal Cord Injury (SCI) |
| Official Title ICMJE | Mental Practice Impact on Gait and Cortical Organization in SCI |
| Brief Summary | Spinal cord injury (SCI) is a disabling condition that impairs fundamental abilities, such as ambulation, respiration, and toileting. Compromised ambulation is a common, devastating impairment following SCI. Yet, despite the fundamental desire to walk, no conventional rehabilitation regimen reliably improves ambulation after SCI, and many SCI patients do not have reliable transportation access, decreasing community integration and access to needed services, including rehabilitation. Little is also known about the subtle neural events that may predict motor recovery in incomplete SCI patients. This study will test a novel, safe, easy to implement technique that has shown promise in improving gait in incomplete SCI patients. The investigators expect that this study will confirm the efficacy of this technique, by showing that it increases the speed and efficiency of walking. This outcome is expected to produce a therapy that improves outcomes and health, and reduces care costs, for community dwelling patients with incomplete SCI. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 2 |
| Study Design ICMJE | Allocation: Randomized Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Condition ICMJE | Incomplete Spinal Cord Injury |
| Intervention ICMJE | Behavioral: Mental practice
All patients in the study will be administered a regimen of locomotor therapy (rehabilitative therapy working on walking). Half of the patients will also be administered a regimen in which they mentally rehearse the exercises that they have just physically performed.
Other Name: Motor imagery |
| Study Arm (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | Not Provided |
| Completion Date | December 2010 |
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Not Provided |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT01302522 |
| Other Study ID Numbers ICMJE | 1R21AT003842-01 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Stephen Page, PhD, University of Cincinnati |
| Study Sponsor ICMJE | University of Cincinnati |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | University of Cincinnati |
| Verification Date | February 2011 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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