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

This study has been completed.
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by:
Wilfrid Laurier University
ClinicalTrials.gov Identifier:
NCT00151359
First received: September 6, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 6, 2005
September 6, 2005
February 2002
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.
Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.

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.

Not Provided
Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
Not Provided
Not Provided
Not Provided
Not Provided
Sensation Disorder
Device: SoleSensor
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

Inclusion Criteria:

  • Aged 65 to 75 years

Exclusion Criteria:

  • Any neurological or musculoskeletal ailments that affect their balance
  • Any drugs that affect balance
Both
65 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00151359
PPP-53686
Not Provided
Not Provided
Wilfrid Laurier University
Sunnybrook Health Sciences Centre
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
Wilfrid Laurier University
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP