Sensation DisorderNCT00151359
Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.
An observational study of Sensation Disorder, run by Wilfrid Laurier University at 1 site in Canada.
Trial 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 . Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensation Disorder
- What is being tested?
- SoleSensor
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Feb 2002to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 to 75 years
Who cannot join
- Any neurological or musculoskeletal ailments that affect their balance
- Any drugs that affect balance
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sensation Disorder
- Being tested
- SoleSensor
- Medical subject headings
- Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoleSensorDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sensation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Wilfrid Laurier University
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Investigators
- Stephen D Perry, PhD, Principal investigator, Wilfrid Laurier UniversityBrian E Maki, PhD, Principal investigator, Centre for Studies In Aging, Sunnybrook & Women'sGeoff R Fernie, PhD, Principal investigator, Centre for Studies In Aging, Sunnybrook & Women's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151359
- Sponsor's protocol ID
- PPP-53686
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2005
- Last updated
- 8 Sep 2005
- Results posted
- No
Publications
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.
PubMed 11532244
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.
- ClinicalTrials.gov ID
- NCT00151359
- Acronym / sponsor ID
- PPP-53686
- Conditions
- Sensation Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Wilfrid Laurier UniversityUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- Feb 2002
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Aged 65 to 75 years
Key exclusion criteria (2 listed)
- Any neurological or musculoskeletal ailments that affect their balance
- Any drugs that affect balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoleSensor | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2005.
- Background: PubMed 11532244Perry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D Perry, PhD principal investigator
Wilfrid Laurier University
Brian E Maki, PhD principal investigator
Centre for Studies In Aging, Sunnybrook & Women's
Geoff R Fernie, PhD principal investigator
Centre for Studies In Aging, Sunnybrook & Women's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensation Disorder, run by Wilfrid Laurier University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00151359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2005.