Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-30 @ 4:19 AM
Study NCT ID:
NCT01508169
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2012-01-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Foot Orthoses and Elderly Women With Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061826', 'term': 'Foot Orthoses'}], 'ancestors': [{'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cecimbarbosa@gmail.com', 'phone': '+55-19-35217113', 'title': 'Cecilia de Morais Barbosa', 'organization': 'Hospital de Clinicas da Universidade Estadual de Campinas (Unicamp)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The subjects from the foot orthoses group were asked to note and report the occurrence of any adverse effects during a four-week period.', 'eventGroups': [{'id': 'EG000', 'title': 'Foot Orthosis', 'description': 'Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.', 'otherNumAtRisk': 47, 'otherNumAffected': 6, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'foot discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'feet heat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tightness of footwear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Berg Balance Scale (BBS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot Orthosis', 'description': 'Fourty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects complited the protocolBalance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.68', 'spread': '4.18', 'groupId': 'OG000'}, {'value': '43.13', 'spread': '6.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The BBS is a balance assessment test that rates the ability of a subject to maintain balance while performing each of 14 movements required in everyday activities (transferring, standing unsupported, rising from a sitting to a standing position, tandem standing, turning 360° and single-leg standing). Scoring is based on an ordinal 5-point scale from 0 to 4. Total scores ranges from 0 to 56. The smaller value, the worse balance: from 0-20: a whell chair is needed: 20-41: needing walk assistence; 41-56 - independent walking.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.'}, {'type': 'PRIMARY', 'title': 'Timed up and Go Test (TUG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot Orthosis', 'description': 'Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four patients finished the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five patients finished the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.97', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '15.82', 'spread': '3.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.'}, {'type': 'SECONDARY', 'title': 'Numeric Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot Orthosis', 'description': 'Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.68', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '3.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Subjects were asked to rate the pain in their feet on a scale from 0 to 10 (0: no pain, 10: extremely severe pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.'}, {'type': 'SECONDARY', 'title': 'Manchester Foot and Pain Disability Index(MFPDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Foot Orthosis', 'description': 'Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four patients completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five patients completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.48', 'spread': '5.56', 'groupId': 'OG000'}, {'value': '22.64', 'spread': '9.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The MFPDI is a test used to assess disability related to foot pain in elderly. It consists of 19 statements prefaced by the phrase "Because of pain in my feet…", organized under three constructs: functional limitation (10 items), pain intensity (five items), and personal appearance (two items). For each statement, there are three possible answers: "none of the time" (score = 0), "some days" (score = 1), and "most days/every day" (score = 2). The final score is the sum of all the items and ranges from 0 to 38. The higher score, the greater disability.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Foot Orthosis', 'description': 'Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'From April 2011 to October 2011, patients in treatment in the outpatient clinic of the Rheumatology Division of Unicamp, who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assessed.', 'preAssignmentDetails': 'From the 242 patients considered eligible, 148 were not included due exclusing criteria (compromised skin integrity of the lower limbs, autoimmune rheumatic diseases, vestibular symptoms, central nervous system pathologies, peripheral neuropathy, use of insoles in the last month, previous foot surgery, inability to attend the reevaluations).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Foot Orthosis', 'description': 'Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.38', 'spread': '6.83', 'groupId': 'BG000'}, {'value': '72.04', 'spread': '7.14', 'groupId': 'BG001'}, {'value': '72.38', 'spread': '6.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-09', 'studyFirstSubmitDate': '2012-01-06', 'resultsFirstSubmitDate': '2012-02-02', 'studyFirstSubmitQcDate': '2012-01-10', 'lastUpdatePostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-09', 'studyFirstPostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg Balance Scale (BBS)', 'timeFrame': '4 weeks', 'description': 'The BBS is a balance assessment test that rates the ability of a subject to maintain balance while performing each of 14 movements required in everyday activities (transferring, standing unsupported, rising from a sitting to a standing position, tandem standing, turning 360° and single-leg standing). Scoring is based on an ordinal 5-point scale from 0 to 4. Total scores ranges from 0 to 56. The smaller value, the worse balance: from 0-20: a whell chair is needed: 20-41: needing walk assistence; 41-56 - independent walking.'}, {'measure': 'Timed up and Go Test (TUG)', 'timeFrame': '4 weeks', 'description': 'The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair.'}], 'secondaryOutcomes': [{'measure': 'Numeric Pain Scale', 'timeFrame': '4 weeks', 'description': 'Subjects were asked to rate the pain in their feet on a scale from 0 to 10 (0: no pain, 10: extremely severe pain)'}, {'measure': 'Manchester Foot and Pain Disability Index(MFPDI)', 'timeFrame': '4 weeks', 'description': 'The MFPDI is a test used to assess disability related to foot pain in elderly. It consists of 19 statements prefaced by the phrase "Because of pain in my feet…", organized under three constructs: functional limitation (10 items), pain intensity (five items), and personal appearance (two items). For each statement, there are three possible answers: "none of the time" (score = 0), "some days" (score = 1), and "most days/every day" (score = 2). The final score is the sum of all the items and ranges from 0 to 38. The higher score, the greater disability.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['elderly', 'balance', 'insole', 'foot orthosis', 'orthotics'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '15029466', 'type': 'BACKGROUND', 'citation': 'Meyer PF, Oddsson LI, De Luca CJ. Reduced plantar sensitivity alters postural responses to lateral perturbations of balance. Exp Brain Res. 2004 Aug;157(4):526-36. doi: 10.1007/s00221-004-1868-3. Epub 2004 Mar 17.'}, {'pmid': '15501837', 'type': 'BACKGROUND', 'citation': 'Melzer I, Benjuya N, Kaplanski J. Postural stability in the elderly: a comparison between fallers and non-fallers. Age Ageing. 2004 Nov;33(6):602-7. doi: 10.1093/ageing/afh218.'}, {'pmid': '21120434', 'type': 'BACKGROUND', 'citation': 'Burke TN, Franca FJ, Meneses SR, Cardoso VI, Pereira RM, Danilevicius CF, Marques AP. Postural control among elderly women with and without osteoporosis: is there a difference? Sao Paulo Med J. 2010 Jul;128(4):219-24. doi: 10.1590/s1516-31802010000400009.'}, {'pmid': '19225271', 'type': 'BACKGROUND', 'citation': 'Bernard-Demanze L, Vuillerme N, Ferry M, Berger L. Can tactile plantar stimulation improve postural control of persons with superficial plantar sensory deficit? Aging Clin Exp Res. 2009 Feb;21(1):62-8. doi: 10.1007/BF03324900.'}, {'pmid': '18684409', 'type': 'BACKGROUND', 'citation': 'Mulford D, Taggart HM, Nivens A, Payrie C. Arch support use for improving balance and reducing pain in older adults. Appl Nurs Res. 2008 Aug;21(3):153-8. doi: 10.1016/j.apnr.2006.08.006.'}, {'pmid': '21450692', 'type': 'BACKGROUND', 'citation': 'Hatton AL, Dixon J, Rome K, Martin D. Standing on textured surfaces: effects on standing balance in healthy older adults. Age Ageing. 2011 May;40(3):363-8. doi: 10.1093/ageing/afr026. Epub 2011 Mar 29.'}, {'pmid': '19424873', 'type': 'BACKGROUND', 'citation': 'Palluel E, Nougier V, Olivier I. Do spike insoles enhance postural stability and plantar-surface cutaneous sensitivity in the elderly? Age (Dordr). 2008 Mar;30(1):53-61. doi: 10.1007/s11357-008-9047-2. Epub 2008 Mar 4.'}, {'pmid': '19824780', 'type': 'BACKGROUND', 'citation': 'Palluel E, Olivier I, Nougier V. The lasting effects of spike insoles on postural control in the elderly. Behav Neurosci. 2009 Oct;123(5):1141-7. doi: 10.1037/a0017115.'}, {'pmid': '14550702', 'type': 'BACKGROUND', 'citation': 'Priplata AA, Niemi JB, Harry JD, Lipsitz LA, Collins JJ. Vibrating insoles and balance control in elderly people. Lancet. 2003 Oct 4;362(9390):1123-4. doi: 10.1016/S0140-6736(03)14470-4.'}, {'pmid': '17267222', 'type': 'BACKGROUND', 'citation': 'Wilson ML, Rome K, Hodgson D, Ball P. Effect of textured foot orthotics on static and dynamic postural stability in middle-aged females. Gait Posture. 2008 Jan;27(1):36-42. doi: 10.1016/j.gaitpost.2006.12.006. Epub 2007 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to determine if foot orthoses are effective in improving balance, pain and disability in elderly women with osteoporosis.', 'detailedDescription': 'Aging has been associated with balance impairment. The use of foot orthoses has been shown to be a feasible strategy for improving postural control.The objective of this study was to determine if foot orthoses (with metatarsal pad and medial arch support) are effective as an adjuvant treatment to improve balance, foot pain and disability in elderly women with osteoporosis. Another purpose was to verify if social demographic and clinical factors such as age, race, education, marital status, age of menopause, use of drugs related to balance dysfunction, visual or hearing complaints, body mass index, previous fractures and number of falls may influence the results.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of osteoporosis\n\nExclusion Criteria:\n\n* reduced tactile and thermal foot sensibility\n* compromised skin integrity of the lower limbs\n* autoimmune rheumatic diseases\n* vestibular symptoms\n* central nervous system pathologies\n* peripheral neuropathy\n* use of insoles in the last month\n* lower limb prostheses\n* previous history of foot surgery\n* amputation of the lower limbs\n* inability to attend the necessary reevaluations and/or to follow instructions and procedures of the research protocol'}, 'identificationModule': {'nctId': 'NCT01508169', 'briefTitle': 'Foot Orthoses and Elderly Women With Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'The Effect of Foot Orthoses on the Balance of Elderly Women With Osteoporosis', 'orgStudyIdInfo': {'id': 'UNICAMP-REUMATO 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foot orthosis', 'description': 'Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.', 'interventionNames': ['Device: Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.'}], 'interventions': [{'name': 'Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)', 'type': 'DEVICE', 'otherNames': ['Orthotics Unit of the Clinical Hospital of UNICAMP.'], 'description': 'Custom foot orthoses made of ethylene-vinyl acetate (EVA) with medial arch supports and metatarsal pads (supporting the diaphysis of the second to fourth metatarsals) that were manufactured by the Orthotics and Prostheses Unit of the Clinical Hospital of UNICAMP.', 'armGroupLabels': ['Foot orthosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Clinical Hospital of The State University of Campinas', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'Eduardo P Magalhaes, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Campinas, Brazil'}, {'name': 'Ibsen B Coimbra, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Campinas, Brazil'}, {'name': 'Michael Davitt', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Campinas, Brazil'}, {'name': 'Cecília M Barbosa, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Campinas, Brazil'}, {'name': 'João Francisco Marques-Neto, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Campinas, Brazil'}, {'name': 'Manoel B Bértolo, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Campinas, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Medical Department of The Faculty of Medical Sciences, State University of Campinas (Unicamp), Brazil', 'investigatorFullName': 'Ibsen Coimbra', 'investigatorAffiliation': 'University of Campinas, Brazil'}}}}