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| Tracking Information | |||||||||
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| First Received Date ICMJE | October 12, 2006 | ||||||||
| Last Updated Date | September 1, 2009 | ||||||||
| Start Date ICMJE | October 2006 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Conduct pre-and post-training assessments of behavioral outcomes using:Wolf Motor Function Test and Jebsen Taylor Hand Function test to measure upper extremity function, hand-held dynamometry to measure pinch grip strength, and Semmes-Weinstein Monofilam [ Time Frame: Outcome measures: baseline, 6 weeks after baseline, post testing, 6 weeks post testing ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00387673 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Prolonged Electrical Stimulation on Neural Plasticity in Spinal Cord Injury | ||||||||
| Official Title ICMJE | Effect of Prolonged Electrical Stimulation on Neural Plasticity in SCI | ||||||||
| Brief Summary | Electrical stimulation (pulses of electricity applied over the skin of your wrist) and activity-based hand exercise have been shown to improve motor skill and strength in individuals with stroke and have recently been shown to also have an effect on individuals with spinal cord injury. Therefore, the purpose of this research study is to investigate whether electrical stimulation alone or electrical stimulation followed by activity-based training produces gains in pinch strength (how hard you can squeeze your thumb and pointer finger together) and upper extremity function (how well your arm and hand can perform activities) in individuals with spinal cord injury. |
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| Detailed Description | Spinal cord injury (SCI) affects 10,000 individuals per year in the United States. Approximately one half of all individuals with SCI have tetraparesis due to cervical injury. Impaired hand function significantly limits the ability of individuals with cervical SCI to perform manual activities of daily living which affects these individuals physically, psychologically and socially. Preliminary research by this investigator suggests that somatosensory stimulation combined with activity-based training improves hand function and strength in individuals with incomplete cervical SCI. Further investigations on these novel techniques are warranted due to the need to establish proven effective rehabilitation techniques that promote recovery of function in individuals with SCI. The purpose of this research study is to: 1)determine if somatosensory stimulation in the form of prolonged, peripheral nerve electrical stimulation can enhance the effect of an upper extremity activity-based training program in individuals with incomplete cervical SCI, and if so, 2) identify the operative neural mechanisms underlying the changes induced with the application of somatosensory stimulation. The hypotheses of this study are that individuals with incomplete cervical SCI:
The specific objectives of this study are to:
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Spinal Cord Injury | ||||||||
| Intervention ICMJE | Behavioral: Somatosensory Stimulation and Massed Practice Training | ||||||||
| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 36 | ||||||||
| Estimated Completion Date | October 2009 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00387673 | ||||||||
| Responsible Party | Beekhuizen, Kristina - Principal Investigator, Department of Veterans Affairs | ||||||||
| Study ID Numbers ICMJE | B4439Z | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | September 2009 | ||||||||
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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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