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Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00151359
First Posted: September 8, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by:
Wilfrid Laurier University
  Purpose
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.

Condition Intervention
Sensation Disorder Device: SoleSensor

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.

Further study details as provided by Wilfrid Laurier University:

Study Start Date: February 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 65 to 75 years

Exclusion Criteria:

  • Any neurological or musculoskeletal ailments that affect their balance
  • Any drugs that affect balance
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151359


Locations
Canada, Ontario
WLU Biomechanics Laboratory
Waterloo, Ontario, Canada, N2L 3C5
Sponsors and Collaborators
Wilfrid Laurier University
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Stephen D Perry, PhD Wilfrid Laurier University
Principal Investigator: Brian E Maki, PhD Centre for Studies In Aging, Sunnybrook & Women's
Principal Investigator: Geoff R Fernie, PhD Centre for Studies In Aging, Sunnybrook & Women's
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00151359     History of Changes
Other Study ID Numbers: PPP-53686
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms