Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT04132167
Status:
UNKNOWN
Last Update Posted:
2019-10-25
First Post:
2017-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supervised Perturbation Training Results in Changes in Balance and Falling in Patients With Multiple Sclerosis
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-23', 'studyFirstSubmitDate': '2017-11-23', 'studyFirstSubmitQcDate': '2019-10-17', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dynamic balance', 'timeFrame': '6 week', 'description': 'the effects of perturbation dynamic balance training assessed with four square step test \\>15 seconds = increased risk of falls'}, {'measure': 'walking', 'timeFrame': '6 week', 'description': 'the effects of perturbation dynamic balance training assessed with 10 meter walking test'}, {'measure': 'walking', 'timeFrame': '6 week', 'description': 'the effects of perturbation dynamic balance training assessed with time up and go test(TUG).A score of 30 seconds or more suggests that the person may be prone to falls'}, {'measure': 'falling', 'timeFrame': '6 week', 'description': 'the effects of perturbation dynamic balance training assessed with Falling Efficacy Scale(FES). The FES is a 10-item test. On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all.'}, {'measure': 'fear of falling', 'timeFrame': '6 week', 'description': 'The short FES-I is a 7-item self-report questionnaire for measuring perceived self-efficacy to avoid a fall in various situations'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rehabilitation', 'Multiple sclerosis', 'Tailored interventions'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Physical exercise can prevent falls, certain types of exercise may be more effective. Perturbation-based balance training is a novel intervention involving repeated postural perturbations aiming to improve control of rapid balance reactions. The purpose of this study was to estimate the effect of perturbation- based balance training on falls and balance in daily life.Thirty patients with multiple sclerosis (PwMS) will assess with regard to dynamic balance, walking and falling. Patients randomly will allocate to a personalized (PRG) or traditional (TRG) rehabilitation group.', 'detailedDescription': 'Thirty patients with multiple sclerosis (PwMS) will assess with regard to dynamic balance, walking and falling. Patients randomly will allocate to a personalized (PRG) or traditional (TRG) rehabilitation group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An age older than 18 years\n* Stable phase of the disease without relapses or worsening in the last three months\n* Referring fear of falling or a history of falls (at least one fall in the last year).\n* Individuals with a high level of balance.\n\nExclusion Criteria:\n\n* Psychiatric disorders\n* Blurred vision\n* Severe cognitive impairment\n* Severely impaired upright postural control or limited participation in a rehabilitation program\n* Cardiovascular and respiratory disorders.'}, 'identificationModule': {'nctId': 'NCT04132167', 'briefTitle': 'Supervised Perturbation Training Results in Changes in Balance and Falling in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Suleyman Demirel University'}, 'officialTitle': 'Supervised Perturbation Training Results in Changes in Balance and Falling in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '12345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'training group', 'description': 'perturbation balance training', 'interventionNames': ['Procedure: perturbation training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'traditional physical therapy that including strengthening and stretching', 'interventionNames': ['Procedure: perturbation training']}], 'interventions': [{'name': 'perturbation training', 'type': 'PROCEDURE', 'description': 'exercises for body stability in different positions (bridge, sitting, quadrupedal, half- kneeling, kneeling, standing, monopodalic) performed with visual biofeedback; transfers training performed in front of a mirror; ambulation training with courses drawn on the ground in a straight line and with more complex tracks with visual controlin particular using the protocols seated balance/strength training, standing bal- ance/weight-bearing training, mobility training and closed-chain training;', 'armGroupLabels': ['control group', 'training group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isparta', 'country': 'Turkey (Türkiye)', 'facility': 'Hatice Yakut', 'geoPoint': {'lat': 37.76444, 'lon': 30.55222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suleyman Demirel University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'HATİCE YAKUT', 'investigatorAffiliation': 'Suleyman Demirel University'}}}}