Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT03945006
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2019-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance, Trunk Impairment and Fear of Falling in Multiple Sclerosis Patients With Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-09', 'studyFirstSubmitDate': '2019-05-08', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the Severity of Incontinence', 'timeFrame': '3 week', 'description': "The Incontinence Severity Index (ISI) was used to assess the MS patients' incontinence severity. The first item is scored between 1 and 4 and the second item is scored between 1 and 3. The total score is calculated by the multiplication of these two answers. The index score is classified as 1-2 slight, 3-6 moderate, 8-9 severe, and 12 very severe."}], 'secondaryOutcomes': [{'measure': 'Static Balance Assessment', 'timeFrame': '3 week', 'description': "The static balance of the patients was measured with a Technobody® stabilometric platform. The test was performed as the patients' arms on the sides, eyes open and closed, and on two feet. Ellipse area, anterior-posterior sway, and medial-lateral sway scores were recorded. As the sway increases, the balance disorder increases."}, {'measure': 'Trunk Impairment Assesment', 'timeFrame': '3 week', 'description': 'Trunk impairment was assessed with the Trunk Impairment Scale. The scale evaluates static and dynamic sitting balance and trunk coordination through 17 items. Each item is scored between 0 and 3. The total score ranges between 0 and 23, and higher scores indicate a better balance performance.'}, {'measure': 'Fear of Falling', 'timeFrame': '3 week', 'description': 'Fear of falling was assessed using the Falls Efficacy Scale. The scale has 10 items assessing the effect of fear of falling on the confidence level of the individuals while performing activities of daily living. Each items is scored by the participants between 0 (not at all concerned) and 10 (very concerned), and the total of the score ranges between 0 (low fall efficacy) and 100 (high fall efficacy).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Balance', 'Trunk impairment', 'Fear of falling', 'Incontinence'], 'conditions': ['Multiple Sclerosis', 'Physical Therapy', 'Incontinence']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to examine balance, trunk impairment, and fear of falling in MS patients with incontinence. Clinical symptoms of the MS patients are heterogenous, and they vary according to the lesion levels and the duration and the type of the disease. In the neurologic group,especially in MS patients, incontinence is observed even at early stages.\n\nPelvic floor muscles contribute to continence by stabilizing the bladder neck and increasing the intraurethral pressure. Furthermore, they mechanically support the spine and the pelvis.This mechanical support is attained through an increase in sacroiliac joint stiffness and intra-abdominal pressure changes, which are important for spinal control. Along with incontinence, this mechanical support deteriorates resulting in some problems. By this way, postural function of pelvic floor muscles may alter in individuals with incontinence, and thus, lumbopelvic stabilization may be negatively affected. In addition, the activity of trunk muscles changes in individuals with incontinence, which may result in spinal movement and affect the posture. Therefore, balance disorders may develop. Postural sways caused by balance disorders and the decrease in postural corrections have been listed among risk the factors associated with falling.\n\nWhen literature is examined, there exists no study examining the effects of incontinence on balance, trunk impairment, and fear of falling in MS patients. For all these reasons, investigators think that incontinence in MS patients has an effect on balance, trunk impairment, and fear of fall.', 'detailedDescription': 'This study was aimed to investigate balance, trunk impairment, and fear of falling in MS patients with and without incontinence.\n\nThe study was conducted in 35 MS patients with an age range of 24-58 years. The patients were divided into two groups based on the occurrence of incontinence. A neurologic examination was performed using the EDSS by a neurologist.\n\nIncontinence was measured with the Incontinence Severity Index (ISI), balance was measured with a Technobody® stabilometric platform, and fear of falling was measured with the Falls Efficacy Scale (FES).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '58 Years', 'minimumAge': '24 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'multiple sclerosis with incontinence and multiple sclerosis without incontinence', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Multiple Sclerosis Disease\n* The level of disability should be between 0.5-4 according to EDSS\n* having a score of 24 or more in the Mini Mental Status Test\n\nExclusion Criteria:\n\n* Patients with acute attacks (six months prior to the study)\n* Mini-Mental State Examination (MMSE) score of less tahn 25 points\n* History of shoulder injury, surgery, medical problems or other neurological disorders in any of the participants'}, 'identificationModule': {'nctId': 'NCT03945006', 'briefTitle': 'Balance, Trunk Impairment and Fear of Falling in Multiple Sclerosis Patients With Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'An Investigation of Balance, Trunk Impairment, and Fear of Falling in Multiple Sclerosis Patients With Incontinence', 'orgStudyIdInfo': {'id': '72'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple Sclerosis Patients with Incontinence', 'description': 'Multiple Sclerosis with incontinence 24-58 years of age and being volunteered.', 'interventionNames': ['Other: Incontinence Severity', 'Other: Balance', 'Other: Trunk impairment', 'Other: Fear of falling']}, {'label': 'Multiple Sclerosis Patients without incontinence', 'description': 'Multiple Sclerosis without incontinence 24-58 years of age and being volunteered.', 'interventionNames': ['Other: Incontinence Severity', 'Other: Balance', 'Other: Trunk impairment', 'Other: Fear of falling']}], 'interventions': [{'name': 'Incontinence Severity', 'type': 'OTHER', 'otherNames': ['Evaluation'], 'description': "The Incontinence Severity Index (ISI) was used to assess the MS patients' incontinence severity.The first item is scored between 1 and 4 and the second item is scored between 1 and 3. The total score is calculated by the multiplication of these two answers. The index score is classified as 1-2 slight, 3-6 moderate, 8-9 severe, and 12 very severe.", 'armGroupLabels': ['Multiple Sclerosis Patients with Incontinence', 'Multiple Sclerosis Patients without incontinence']}, {'name': 'Balance', 'type': 'OTHER', 'otherNames': ['Evaluation'], 'description': "The patients were assessed while their bladders were empty. The static balance of the patients was measured with a Technobody® stabilometric platform. The patients were assessed while their bladders were empty. The test was performed as the patients' arms on the sides, eyes open and closed, and on two feet. Ellipse area, anterior-posterior sway, and medial-lateral sway scores were recorded.", 'armGroupLabels': ['Multiple Sclerosis Patients with Incontinence', 'Multiple Sclerosis Patients without incontinence']}, {'name': 'Trunk impairment', 'type': 'OTHER', 'otherNames': ['Evaluation'], 'description': "Trunk impairment was assessed with the Trunk Impairment Scale (TIS) while the participants' bladders were empty. The scale evaluates static and dynamic sitting balance and trunk coordination through 17 items. Each item is scored between 0 and 3. The total score ranges between 0 and 23, and higher scores indicate a better balance performance.", 'armGroupLabels': ['Multiple Sclerosis Patients with Incontinence', 'Multiple Sclerosis Patients without incontinence']}, {'name': 'Fear of falling', 'type': 'OTHER', 'otherNames': ['Evaluation'], 'description': 'Fear of falling was assessed using the Falls Efficacy Scale developed by Tinetti and colleagues. The scale has 10 items assessing the effect of fear of falling on the confidence level of the individuals while performing activities of daily living. Each items is scored by the participants between 0 (not at all concerned) and 10 (very concerned), and the total of the score ranges between 0 (low fall efficacy) and 100 (high fall efficacy)', 'armGroupLabels': ['Multiple Sclerosis Patients with Incontinence', 'Multiple Sclerosis Patients without incontinence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06970', 'city': 'Ankara', 'state': 'Esenboğa', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}