Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT00151359
Status:
COMPLETED
Last Update Posted:
2005-09-08
First Post:
2005-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012678', 'term': 'Sensation Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2005-09-06', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Sensation Disorder']}, 'referencesModule': {'references': [{'pmid': '11532244', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 65 to 75 years\n\nExclusion Criteria:\n\n* Any neurological or musculoskeletal ailments that affect their balance\n* Any drugs that affect balance'}, 'identificationModule': {'nctId': 'NCT00151359', 'briefTitle': "Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.", 'organization': {'class': 'OTHER', 'fullName': 'Wilfrid Laurier University'}, 'officialTitle': "Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.", 'orgStudyIdInfo': {'id': 'PPP-53686'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SoleSensor', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3C5', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'WLU Biomechanics Laboratory', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Stephen D Perry, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wilfrid Laurier University'}, {'name': 'Brian E Maki, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre for Studies In Aging, Sunnybrook & Women's"}, {'name': 'Geoff R Fernie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre for Studies In Aging, Sunnybrook & Women's"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wilfrid Laurier University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}]}}}