Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01145118
Status:
COMPLETED
Last Update Posted:
2012-01-24
First Post:
2010-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reliability of Functional Outcome Measures in Plantar Fascitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-21', 'studyFirstSubmitDate': '2010-05-24', 'studyFirstSubmitQcDate': '2010-06-15', 'lastUpdatePostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Limitation', 'timeFrame': '1 week', 'description': 'Measurement of Functional Limitation using Foot Function Index (FFI) compared to the healthy foot'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '1 week', 'description': 'Measurement of pain intensity using visual analog scale (VAS), compared to the healthy foot'}, {'measure': 'Pain threshold', 'timeFrame': '1 week', 'description': 'Measurement of pain threshold using a Pressure Algometer, compared to the healthy foot'}, {'measure': 'Muscle strength', 'timeFrame': '1 week', 'description': 'Measurement of Muscle strength in Plantar Flexion and Dorsi Flexion using Hand Held Dinamometer - compared to the healthy foot.'}, {'measure': 'Range of motion', 'timeFrame': '1 week', 'description': 'Measurement of Range of motion using a Digital inclinometer - compared to the healthy foot'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Plantar Fasciitis', 'Physiotherapy'], 'conditions': ['Plantar Fasciitis']}, 'descriptionModule': {'briefSummary': 'Plantar Fasciitis (PF) is the most common foot condition treated by healthcare providers, striking approximately 2 million Americans each year. Nevertheless its causes are still not known. The risk factors for PF are known and the diagnosis, which is based on clinical assessment, is relatively simple. Still most of the treatments for PF focus on short term symptoms relief instead of prevention or reduction of recurrence.\n\nPhysical therapy treatment that focuses on reducing the symptoms for the long run and prevention, should include outcome measures, which if found to be reliable, will make the diagnosis clearer. Diagnosis based on reliable clinical and functional measures will assist the physical therapist to understand the major deficiencies of the patient, and accordingly to help him to make the right decision in choosing treatment. Also comprehensive knowledge of the characteristics of PF may enable selection of appropriate preventive measures.', 'detailedDescription': 'Objectives:\n\nCharacterize the unilateral PF syndrome using functional outcome measures, while comparing them to the healthy foot of the same patient. In addition the study will investigate the reliability of these functional outcome measures in PF patients.\n\nMethodology:\n\nIndividuals referred to physiotherapy for PF will be assessed for eligibility and consent for the study. They will undergo two evaluations on the same week to evaluate the test- retest reliability of the functional measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals referred to community physiotherapy center for plantar Fasceitis treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral plantar fasciitis\n* Painful first step in the morning\n* Calcaneal soreness in palpation\n* Insured by Clalit Health Care Services\n* Signed informed consent\n\nExclusion Criteria:\n\n* Ankle or foot surgery\n* Congenital deformation of foot\n* Lower limb spasticity\n* Using assistive devices\n* Bilateral plantar fasciitis\n* Refuse to participate or sign informed consent'}, 'identificationModule': {'nctId': 'NCT01145118', 'briefTitle': 'Reliability of Functional Outcome Measures in Plantar Fascitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Clalit Health Services'}, 'officialTitle': 'Reliability of Functional Outcome Measures in Plantar Fascitis Patients', 'orgStudyIdInfo': {'id': 'K-10-0037-ctil'}}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Clalit Health Services, Haifa and Western Galilee District', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Uzi Milman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL'}, {'name': 'HASAN KHAIRELDIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL'}, {'name': 'SHARON ISRAELY, BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clalit Health Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL.', 'investigatorFullName': 'Uzi Milman', 'investigatorAffiliation': 'Clalit Health Services'}}}}