Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-26 @ 12:45 AM
Study NCT ID:
NCT03328468
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2017-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Upper Limb Motor Scale to Measure Quality of Movement and Body Awareness in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001945', 'term': 'Breathing Exercises'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2017-10-19', 'studyFirstSubmitQcDate': '2017-10-27', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability of a new scale for stroke: Awareness of Functional Tasks with Arm and Hand in Stroke (AFAS scale)', 'timeFrame': 'Baseline', 'description': 'AFAS contains 13 items'}, {'measure': 'Validity a new motor scale for upper extremity Upper Limb Motor Scale in people with stroke (AFAS scale', 'timeFrame': 'Baseline', 'description': 'Scale using 0-45 for measurement, 0 being low and 45 being high.'}], 'secondaryOutcomes': [{'measure': 'Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES)', 'timeFrame': 'Baseline', 'description': 'Scale using 0-58 for measurement, 0 being low and 58 being high. Assesses qualities of the arm and hand.'}, {'measure': 'Revised Body Awareness Rating Scale (REVBA)', 'timeFrame': 'Baseline', 'description': 'The Revised Body Awareness Rating Scales contains 12 items rated on a 4-point scale. Total scores range from 0 to 36 with lower scores indicating better body awareness.'}, {'measure': 'Physical Body Experience Questionnaire (PBE)', 'timeFrame': 'Baseline', 'description': 'The Physical Body Experience Questionnaire contains 12 items, rated on a 7-point Likert scale. Total scores range from 0 to 48 with lower scores indicated better physical body experience.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke'], 'conditions': ['Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.med.umn.edu/rehabmedicine/research/motor-scale-awareness', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'For the breathing intervention, participants completed two experimental sessions at least two weeks apart. The experimental sessions were randomized between the slow-breathing condition (6 breaths/min) or the control breathing condition (12 breaths/min). Breathing interventions were 15 minutes in length and completed with the assistance of the breathing app, Breathe Deep (Mineev, Bizi Apps LLC).\n\nThe breathing intervention is currently completed.\n\nThe reliability and validity study of AFAS is ongoing. This is a one-time visit for participants in which participants will undergo screening of sensation and movement as well as fill in some questionnaires.', 'detailedDescription': 'All participants had two visits for the breathing exercise. The only planned intervention was the breathing exercise, which is now concluded.\n\nThe protocol for the breathing intervention was as follows: The breathing protocol lasted 15 minutes. It was a guided breathing awareness session with a registered nurse (PhD student) who is also trained in integrative therapies and yoga instruction.\n\nIn parallel, during one of the visits the reliability and validity of a new scale for stroke to measure quality of movement and body awareness is tested.\n\nThis part is still ongoing and thus this becomes a one-time visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females and males ages 18-99 years of age\n* People with stroke who are medically stable with one or more ischemic or\n* hemorrhagic stroke(s)\n* left or right hemiplegia\n* willing and able to attend a one-time behavioral testing session\n* willing and able to sign consent to participate\n* able to hear, read and comprehend instructions given during the study\n* English speaking (or willing to work with a (student) translator)\n\nExclusion Criteria:\n\n* cognitive impairment (Mini-mental State Exam-brief version, \\<13/16)\n* contractures in the tested arm that would hinder testing arm movements\n* adults lacking capacity to consent\n* severe neglect, aphasia, apraxia\n* other medical conditions that preclude participation'}, 'identificationModule': {'nctId': 'NCT03328468', 'acronym': 'AFAS', 'briefTitle': 'Development of Upper Limb Motor Scale to Measure Quality of Movement and Body Awareness in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Development of Upper Limb Motor Scale "Awareness of Functional Tasks With Arm and Hand in Stroke"', 'orgStudyIdInfo': {'id': 'PMR-2017-25877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breathing Exercise', 'interventionNames': ['Other: Breathing Exercise']}], 'interventions': [{'name': 'Breathing Exercise', 'type': 'OTHER', 'description': 'Breathing exercise for stroke patients', 'armGroupLabels': ['Breathing Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Ann Van de Winckel, PhD, MS, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}