Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT03938558
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2019-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Art for MS - Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005221', 'term': 'Fatigue'}], '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'}, {'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'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study distinguish two groups contributing to a dance and art production. The experimental group will perform 10 weeks of dance training, while the other group will contribute to the production in various ways (e.g. word art, photography, painting, …).\n\nMeasures will be taken before and after the training or assistance in the production.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2019-05-02', 'studyFirstSubmitQcDate': '2019-05-02', 'lastUpdatePostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'motor fatigability', 'timeFrame': 'Baseline', 'description': 'Performance motor fatigability: Calculating the Distance Walked Index (DWI) during 6MWT.\n\nFormula for walking-related performance fatigability: DWI = (\\[Distance walked at minute 6 - Distance walked at minute 1\\]/Distance walked at minute 1) × 100'}, {'measure': 'motor fatigability', 'timeFrame': 'week 10', 'description': 'Performance motor fatigability: Calculating the Distance Walked Index (DWI) during 6MWT.\n\nFormula for walking-related performance fatigability: DWI = (\\[Distance walked at minute 6 - Distance walked at minute 1\\]/Distance walked at minute 1) × 100'}, {'measure': 'motor fatigability', 'timeFrame': 'week 20', 'description': 'Performance motor fatigability: Calculating the Distance Walked Index (DWI) during 6MWT.\n\nFormula for walking-related performance fatigability: DWI = (\\[Distance walked at minute 6 - Distance walked at minute 1\\]/Distance walked at minute 1) × 100'}, {'measure': 'Trait motor fatigue', 'timeFrame': 'baseline', 'description': 'Modified Fatigue Impact Scale (MFIS)'}, {'measure': 'Trait motor fatigue', 'timeFrame': 'week 10', 'description': 'Modified Fatigue Impact Scale (MFIS)'}, {'measure': 'Trait motor fatigue', 'timeFrame': 'week 20', 'description': 'Modified Fatigue Impact Scale (MFIS)'}], 'secondaryOutcomes': [{'measure': 'Coördination test with lower limbs', 'timeFrame': 'baseline', 'description': 'seated bipedal coordination task (knee flexion and extension movements during 6 minutes, and metronome based 0,75 Hz, 1Hz and 1,5 Hz for 1 minute)'}, {'measure': 'Coördination test with lower limbs', 'timeFrame': 'week 10', 'description': 'seated bipedal coordination task (knee flexion and extension movements during 6 minutes, and metronome based 0,75 Hz, 1Hz and 1,5 Hz for 1 minute)'}, {'measure': 'Coördination test with lower limbs', 'timeFrame': 'week 20', 'description': 'seated bipedal coordination task (knee flexion and extension movements during 6 minutes, and metronome based 0,75 Hz, 1Hz and 1,5 Hz for 1 minute)'}, {'measure': 'Perceived motor fatigability', 'timeFrame': 'Baseline', 'description': 'VAS increase minute per minute during 6MWT (range 0-10)'}, {'measure': 'Perceived motor fatigability', 'timeFrame': 'week 10', 'description': 'VAS increase minute per minute during 6MWT (range 0-10)'}, {'measure': 'Perceived motor fatigability', 'timeFrame': 'week 20', 'description': 'VAS increase minute per minute during 6MWT (range 0-10)'}, {'measure': 'Performance cognitive fatigability and cognitive capacity', 'timeFrame': 'Baseline', 'description': 'PASAT and SDMT total score and correct answers last ⅓ vs first ⅓'}, {'measure': 'Performance cognitive fatigability and cognitive capacity', 'timeFrame': 'week 10', 'description': 'PASAT and SDMT total score and correct answers last ⅓ vs first ⅓'}, {'measure': 'Performance cognitive fatigability and cognitive capacity', 'timeFrame': 'week 20', 'description': 'PASAT and SDMT total score and correct answers last ⅓ vs first ⅓'}, {'measure': 'Trait fatigue', 'timeFrame': 'Baseline', 'description': 'Fatigue Severity Scale (FSS) : range 1-7'}, {'measure': 'Trait fatigue', 'timeFrame': 'week 10', 'description': 'Fatigue Severity Scale (FSS) : range 1-7'}, {'measure': 'Trait fatigue', 'timeFrame': 'week 20', 'description': 'Fatigue Severity Scale (FSS) : range 1-7'}, {'measure': 'MSIS-29 Questionnaire', 'timeFrame': 'Baseline', 'description': 'Impact of MS via a questionnaire. 29 items, total score on 145.'}, {'measure': 'MSIS-29 Questionnaire', 'timeFrame': 'week 10', 'description': 'Impact of MS via a questionnaire. 29 items, total score on 145.'}, {'measure': 'MSIS-29 Questionnaire', 'timeFrame': 'week 20', 'description': 'Impact of MS via a questionnaire. 29 items, total score on 145.'}, {'measure': 'SF-36 Questionnaire', 'timeFrame': 'Baseline', 'description': 'Quality of Life health related questionnaire. Scale 0-100'}, {'measure': 'SF-36 Questionnaire', 'timeFrame': 'week 10', 'description': 'Quality of Life health related questionnaire. Scale 0-100'}, {'measure': 'SF-36 Questionnaire', 'timeFrame': 'week 20', 'description': 'Quality of Life health related questionnaire. Scale 0-100'}, {'measure': 'ABC scale', 'timeFrame': 'Baseline', 'description': 'Activity balance confidence scale. Scale has 16 items and is transferred to a percentage.'}, {'measure': 'ABC scale', 'timeFrame': 'week 10', 'description': 'Activity balance confidence scale. Scale has 16 items and is transferred to a percentage.'}, {'measure': 'ABC scale', 'timeFrame': 'week 20', 'description': 'Activity balance confidence scale. Scale has 16 items and is transferred to a percentage.'}, {'measure': 'MSWS-12 Questionnaire', 'timeFrame': 'Baseline', 'description': 'Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12.'}, {'measure': 'MSWS-12 Questionnaire', 'timeFrame': 'week 10', 'description': 'Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12.'}, {'measure': 'MSWS-12 Questionnaire', 'timeFrame': 'week 20', 'description': 'Questionnaire about walking in MS, 12 items, total score on 60, minimum score 12.'}, {'measure': '5xSTS T25FW', 'timeFrame': 'Baseline', 'description': '5 times sit to stand test, where patients have to stand and sit 5 times as fast as possible. Determined in seconds'}, {'measure': '5xSTS T25FW', 'timeFrame': 'week 10', 'description': '5 times sit to stand test, where patients have to stand and sit 5 times as fast as possible. Determined in seconds'}, {'measure': '5xSTS T25FW', 'timeFrame': 'week 20', 'description': '5 times sit to stand test, where patients have to stand and sit 5 times as fast as possible. Determined in seconds'}, {'measure': 'T25FW test', 'timeFrame': 'Baseline', 'description': 'patients have to walk 25 feet as fast as possible. Determined in seconds'}, {'measure': 'T25FW test', 'timeFrame': 'week 10', 'description': 'patients have to walk 25 feet as fast as possible. Determined in seconds'}, {'measure': 'T25FW test', 'timeFrame': 'week 20', 'description': 'patients have to walk 25 feet as fast as possible. Determined in seconds'}, {'measure': 'NHPT (Nine hole peck test)', 'timeFrame': 'Baseline', 'description': 'Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds.'}, {'measure': 'NHPT (Nine hole peck test)', 'timeFrame': 'week 10', 'description': 'Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds.'}, {'measure': 'NHPT (Nine hole peck test)', 'timeFrame': 'week 20', 'description': 'Nine hole peck test: descriptive measure for hand dexterity. Measured in seconds.'}, {'measure': 'DGI (Dynamic gait index)', 'timeFrame': 'Baseline', 'description': 'patient have to perform several static and dynamic balance test. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score = 24'}, {'measure': 'DGI (Dynamic gait index)', 'timeFrame': 'week 10', 'description': 'patient have to perform several static and dynamic balance test. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score = 24'}, {'measure': 'DGI (Dynamic gait index)', 'timeFrame': 'week 20', 'description': 'patient have to perform several static and dynamic balance test. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score = 24'}, {'measure': 'EmNSA', 'timeFrame': 'Baseline', 'description': 'Dynamic gait index: patient have to perform several static and dynamic balance test. A ordinal scale, ranging from 0-2. "0" indicates the lowest level of function and "2" the highest level of function. Total Score = 48'}, {'measure': 'EmNSA', 'timeFrame': 'week 10', 'description': 'Dynamic gait index: patient have to perform several static and dynamic balance test. A ordinal scale, ranging from 0-2. "0" indicates the lowest level of function and "2" the highest level of function. Total Score = 48'}, {'measure': 'EmNSA', 'timeFrame': 'week 20', 'description': 'Dynamic gait index: patient have to perform several static and dynamic balance test. A ordinal scale, ranging from 0-2. "0" indicates the lowest level of function and "2" the highest level of function. Total Score = 48'}, {'measure': 'CMI (Cognitive motor interference)', 'timeFrame': 'Baseline', 'description': 'Dual task testing during 1 min tasks and 6 minutes task to measure alertness of movement control.\n\nDual task testing during 1 min tasks and 6 minutes task to measure alertness of movement control.'}, {'measure': 'CMI (Cognitive motor interference)', 'timeFrame': 'week 10', 'description': 'Dual task testing during 1 min tasks and 6 minutes task to measure alertness of movement control.\n\nDual task testing during 1 min tasks and 6 minutes task to measure alertness of movement control.'}, {'measure': 'CMI (Cognitive motor interference)', 'timeFrame': 'week 20', 'description': 'Dual task testing during 1 min tasks and 6 minutes task to measure alertness of movement control.\n\nDual task testing during 1 min tasks and 6 minutes task to measure alertness of movement control.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'fatigue'], 'conditions': ['Multiple Sclerosis', 'Fatigue']}, 'referencesModule': {'references': [{'pmid': '34744669', 'type': 'DERIVED', 'citation': 'Goetschalckx M, Van Geel F, Meesen R, Triccas LT, Geraerts M, Moumdjian L, Feys P. Interlimb Coordination Performance in Seated Position in Persons With Multiple Sclerosis: Reduced Amplitude Over 6 min and Higher Coordination Variability in Persons With Walking Fatigability. Front Hum Neurosci. 2021 Oct 20;15:765254. doi: 10.3389/fnhum.2021.765254. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'This study is a controlled pilot study with 17 participants with Multiple Sclerosis (MS). The primary goal of this study is to objectively examine the effects of a multimodal dance intervention on walking-related performance fatigability. The secondary aim is to investigate the effects of a multimodal dance intervention on other MS symptoms related to fatigue and fatigability.\n\nThe following research questions will be addressed:\n\n1. Does a multimodal dance intervention have positive effects on walking-related fatigability?\n2. Does a multimodal dance intervention have positive effects on other MS symptoms related to fatigue and fatigability?', 'detailedDescription': 'This study distinguish two groups contributing to a dance and art production. The experimental group will perform 10 weeks of dance training, while the other group will contribute to the production in various ways (e.g. word art, photography, painting, …).\n\nMeasures will be taken before and after the training or assistance in the production.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 - 70 years\n* Confirmed diagnosis according to the McDonald criteria\n* Able to walk independently or with bilateral support for 6 minutes\n* Signed the informed consent\n\nExclusion Criteria:\n\n* Exacerbation or relapse within last 3 months before onset study\n* Other medical conditions interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis, fibromyalgia, Parkinson and stroke)'}, 'identificationModule': {'nctId': 'NCT03938558', 'briefTitle': 'Art for MS - Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Art for MS - Effects of a 10 Week Multimodal Dance and Art Intervention Program on Fatigue, Fatigability, and Their Related Factors - A Controlled Pilot-trial', 'orgStudyIdInfo': {'id': 'B9115201836892'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dance intervention group', 'description': '* Dancers at beginners level\n* Dancers at advanced level', 'interventionNames': ['Other: MS-Dance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Art intervention group', 'description': '* Paint artists\n* Word artists\n* Film artists\n* Photographers', 'interventionNames': ['Other: MS-Art']}], 'interventions': [{'name': 'MS-Dance', 'type': 'OTHER', 'description': 'The experimental group will perform 10 weeks of dance training', 'armGroupLabels': ['Dance intervention group']}, {'name': 'MS-Art', 'type': 'OTHER', 'description': 'The other group will contribute to the production in various ways (e.g. word art, photography, painting, …)', 'armGroupLabels': ['Art intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Hasselt University', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'peter Feys, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasselt University'}, {'name': 'Fanny Van Geel, drs.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hasselt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter Feys', 'investigatorAffiliation': 'Hasselt University'}}}}