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OpenTrials
Completed

NCT Number: NCT00151359

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.

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Key information

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

WLU Biomechanics Laboratory

Waterloo, Ontario, N2L 3C5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 65 to 75 years

Exclusion criteria

  • Any neurological or musculoskeletal ailments that affect their balance
  • Any drugs that affect balance

Treatment and study plan

SoleSensor

Device

Sponsors and collaborators

Lead sponsor

Wilfrid Laurier University

Other

Collaborators

  • Sunnybrook Health Sciences Centre

Registry information

Important dates

Study start
2002
First posted
Sep 8, 2005
Registry last updated
Sep 8, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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