Neural Prostheses and Gait Performance: Model-Based Strategies
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| First Received Date ICMJE | October 2, 2009 | ||||||||
| Last Updated Date | April 30, 2013 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Walking stability and speed [ Time Frame: Within 3 mos. ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00991406 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 | Neural Prostheses and Gait Performance: Model-Based Strategies | ||||||||
| Official Title ICMJE | Neural Prostheses and Gait Performance: Model-Based Strategies | ||||||||
| Brief Summary | The purpose of this research is to find the optimal patterns of functional electrical stimulation (FES) of muscles in the lower legs that will improve walking ability in those who have had a stroke and at the same time ensure walking stability. FES involves applying small electric currents to the nerves, which cause the muscles to contract. FES research projects vary from simple investigations of the therapeutic effects of exercise on muscle function and skin health, to more complex studies of functional movements such as standing or walking. |
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| Detailed Description | The study aims to find the optimal patterns of functional electrical stimulation (FES) of muscles in the lower legs that will improve walking ability in those who have had a stroke and at the same time ensure walking stability will be achieved through an analytical approach comprised of computational models and gait simulations to objectively determine patient-specific patterns of muscle activation. We will develop a computer simulation of the dynamics of hemiplegic gait characterized by unilateral plantarflexor weakness. Then, we will relate the results of the computer model results to real data collected from subjects with known plantarflexor weakness to provide a theoretical basis for improving gait efficiency and stability with FES. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Hemiplegia | ||||||||
| Intervention ICMJE | Device: EMS 2000
Surface stimulation to contract the muscles in the lower extremity |
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| Study Arm (s) | Experimental: Arm 1
Case-control study: pre- and post-stimulation (FES).
Intervention: Device: EMS 2000 |
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| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: This study includes stroke survivors greater than 18 years of age, >180 days from first clinical hemorrhagic or nonhemorrhagic stroke with:
Exclusion Criteria: In addition to failure to meet the inclusion criteria, participants will be excluded from the study for the following:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00991406 | ||||||||
| Other Study ID Numbers ICMJE | B4668-R | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Department of Veterans Affairs | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | April 2013 | ||||||||
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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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