Amputee Residual Limb Volume Fluctuation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Washington.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Washington
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01161238
First received: July 9, 2010
Last updated: November 18, 2010
Last verified: November 2010
| Tracking Information | |||||
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| First Received Date ICMJE | July 9, 2010 | ||||
| Last Updated Date | November 18, 2010 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01161238 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 | Amputee Residual Limb Volume Fluctuation | ||||
| Official Title ICMJE | Measuring and Controlling In-Socket Residual Limb Volume Fluctuation | ||||
| Brief Summary | The goal of this project is a useful clinical instrument for diagnosis and treatment of residual limb volume fluctuation in individuals who use prosthetic limbs. One hypothesis to be tested is that the instrument effectively measures short and long term volume fluctuations in individuals with trans-tibial amputation. Another hypothesis to be tested is that when subjects add a sock or insert to the prosthesis residual limb volume decreases, and when they remove the sock or insert residual limb volume increases. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | people with lower limb amputation that are ambulatory |
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| Condition ICMJE | Amputation | ||||
| Intervention ICMJE | Other: Monitored for limb volume
Subjects are monitored for limb volume change using bioimpedance analysis |
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| Study Group/Cohort (s) | Lower-limb amputee
Subjects with at least one lower limb amputated at the trans-tibial level
Intervention: Other: Monitored for limb volume |
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| Publications * | Sanders JE, Harrison DS, Allyn KJ, Myers TR. Clinical utility of in-socket residual limb volume change measurement: case study results. Prosthet Orthot Int. 2009 Dec;33(4):378-90. | ||||
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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 | 100 | ||||
| Estimated Completion Date | September 2011 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01161238 | ||||
| Other Study ID Numbers ICMJE | 30863-E/B, R01HD060585 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Joan E Sanders PhD, University of Washington | ||||
| Study Sponsor ICMJE | University of Washington | ||||
| Collaborators ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | University of Washington | ||||
| Verification Date | November 2010 | ||||
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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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