Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.
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| First Received Date ICMJE | September 6, 2005 | ||||||||||||
| Last Updated Date | September 6, 2005 | ||||||||||||
| Start Date ICMJE | February 2002 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | No Changes Posted | ||||||||||||
| 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 | Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert. | ||||||||||||
| Official Title ICMJE | Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert. | ||||||||||||
| Brief Summary | Our research has shown that pressure sensation from the soles of the feet (plantar mechanoreceptors) plays an important role in controlling several key aspects of balancing reactions, particularly during compensatory stepping . As a result, age-related loss of plantar pressure sensation, which is very common, can lead to impaired control of these reactions. However, we have shown that it is possible to compensate for balance impairments resulting from this loss of sensation by using special footwear insoles to facilitate sensation from the perimeter of the sole. To date, we have demonstrated the feasibility of this approach in laboratory studies, and we have obtained a U.S. patent for the design concept. However, it remains to be determined whether the benefits of the footwear persist over the long term, or whether there is a habituation of the effect. Also, we need to determine whether there are any practical problems associated with wearing such footwear, e.g. due to discomfort or irritation of the skin. |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Defined Population Time Perspective: Longitudinal Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| Sampling Method | Not Provided | ||||||||||||
| Study Population | Not Provided | ||||||||||||
| Condition ICMJE | Sensation Disorder | ||||||||||||
| Intervention ICMJE | Device: SoleSensor | ||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||
| Publications * | Perry SD, Santos LC, Patla AE. Contribution of vision and cutaneous sensation to the control of centre of mass (COM) during gait termination. Brain Res. 2001 Sep 14;913(1):27-34. | ||||||||||||
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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 | Not Provided | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 65 Years to 75 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Canada | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00151359 | ||||||||||||
| Other Study ID Numbers ICMJE | PPP-53686 | ||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||
| Responsible Party | Not Provided | ||||||||||||
| Study Sponsor ICMJE | Wilfrid Laurier University | ||||||||||||
| Collaborators ICMJE | Sunnybrook Health Sciences Centre | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Wilfrid Laurier University | ||||||||||||
| Verification Date | September 2005 | ||||||||||||
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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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