NCT00151359

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

September 8, 2005

Status Verified

September 1, 2005

First QC Date

September 6, 2005

Last Update Submit

September 6, 2005

Conditions

Sensation Disorder

Interventions

SoleSensorDEVICE

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65 to 75 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WLU Biomechanics Laboratory

Waterloo, Ontario, N2L 3C5, Canada

Location

Related Publications (1)

  • 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. doi: 10.1016/s0006-8993(01)02748-2.

    PMID: 11532244BACKGROUND

MeSH Terms

Conditions

Sensation Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

February 1, 2002

Last Updated

September 8, 2005

Record last verified: 2005-09

Locations

CA(1)