Sensation Disorder Clinical Trial
Official title:
Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.
| NCT number | NCT00151359 |
| Other study ID # | PPP-53686 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | September 6, 2005 |
| Last updated | September 6, 2005 |
| Start date | February 2002 |
| Verified date | September 2005 |
| Source | Wilfrid Laurier University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 65 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Aged 65 to 75 years Exclusion Criteria: - Any neurological or musculoskeletal ailments that affect their balance - Any drugs that affect balance |
Observational Model: Defined Population, Time Perspective: Longitudinal
| Country | Name | City | State |
|---|---|---|---|
| Canada | WLU Biomechanics Laboratory | Waterloo | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Wilfrid Laurier University | Sunnybrook Health Sciences Centre |
Canada,
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. — View Citation