Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-05 @ 3:05 PM
Study NCT ID:
NCT03120156
Status:
COMPLETED
Last Update Posted:
2017-11-13
First Post:
2017-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Sensomotoric Insoles on Postural Control in Elderly People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Sensomotoric insoles and normal insoles or no insoles are not maskable.Patients and all involved persons will be able to easily see which type of insoles are used.\n\nNo blinding possible.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-09', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-04-18', 'lastUpdatePostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Posturographic measurement with Kistler's measuring plate", 'timeFrame': '30 min.', 'description': 'a validated posturgraphy plate is measuring the balance ability'}], 'secondaryOutcomes': [{'measure': 'Tinetti Balance and Gait instrument', 'timeFrame': '15 min.', 'description': 'Well established tool for measuring balance ability of elderly people'}, {'measure': 'Functional reach test', 'timeFrame': '5 min', 'description': 'Well established tool for measuring balance ability'}, {'measure': 'ABC-Scale', 'timeFrame': '15 min', 'description': 'Questionnaire-Score for evaluation subjective feelings of unsure gait patterns or dizziness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sensomotoric insoles', 'postural control', 'proprioceptive insoles', 'insoles'], 'conditions': ['Sensorimotor Gait Disorder']}, 'descriptionModule': {'briefSummary': 'People with weak balance ability or subjective feeling of dizziness and unsure gait are separated into 3 training-groups. One Group is getting no insoles, the second group is getting modern sensomotoric insoles, and the third group is getting normal standard insoles. All are passing a 6 week proprioceptive training.\n\nMain outcome measurements are posturography at baseline, 3 weeks and 6 weeks. Secondary measurements are ABC-Scale, Tinetti Gait and balance test and functional reach test at baseline and after 6 weeks.', 'detailedDescription': 'People with weak balance ability or subjective feeling of dizziness and unsure gait are separated into 3 training-groups. Exclusion criteria are structural neuropathic cause for dizziness, severe ocular deficience, cochlear causes for dizziness.\n\nThe 3 Groups differ in following criteria:\n\nGroup 1: Gets basic insoles after 3-D-Scan of the foot Group 2: Gets sensomotoric insoles (Jahrling) after 3-D-Scan of the foot. Group 3: Control-Group = no insoles\n\nAlle groups are doing a 6 weeks proprioceptive training 2 times a week for 45min. Balance-Ability is measured by a posturographic plate prior to the training, after 3 weeks training and after 6 weeks of training. ABC-Score, Tinetti Gait and Balance test and functional reach test are secondary outcome measurements and are evaluated prior the training and after 6 weeks of training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nABC-Scale \\< 70% Functional reach test \\< 30cm Subjective feeling of unsure gait or several falls in the last 5 years\n\nExclusion Criteria:\n\nStructural pathologies in the balance system Neuropathologies like Polyneuropathy'}, 'identificationModule': {'nctId': 'NCT03120156', 'briefTitle': 'Effects of Sensomotoric Insoles on Postural Control in Elderly People', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Effects of Sensomotoric Insoles on Postural Control in Elderly People - a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Senso-Insoles for Balance'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No insoles', 'description': "Control group of people with poor postural control that won't use insoles", 'interventionNames': ['Other: No insoles']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal insoles', 'description': 'Control group of people with poor postural control that will get normal standard insoles.', 'interventionNames': ['Device: normal standard insoles']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sensomotoric insoles', 'description': 'Control group of people with poor postural control that will get normal standard insoles.', 'interventionNames': ['Device: sensomotoric insoles']}], 'interventions': [{'name': 'sensomotoric insoles', 'type': 'DEVICE', 'description': 'sensomotoric insoles were published by Jahrling (2007) and have a certain shape that could improve balance abilities. The toes 2-4 are higher that toe 1, so that the tendons of the toe-flectors are pre-stressed.', 'armGroupLabels': ['Sensomotoric insoles']}, {'name': 'normal standard insoles', 'type': 'DEVICE', 'description': 'Normal standard insole like you will get them by receipe from an orthotic shop', 'armGroupLabels': ['Normal insoles']}, {'name': 'No insoles', 'type': 'OTHER', 'description': 'control group with no insoles in the shoes', 'armGroupLabels': ['No insoles']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'PD Dr. Martin Weigl, MPH', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}