Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT04762927
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2021-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metric Properties of de Morton Mobility Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-17', 'studyFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'de Morton Mobility Index - change', 'timeFrame': 'Approximately 30 days (difference between admission and discharge)', 'description': 'DEMMI is a unidimensional 15-item measure of mobility for adults'}], 'secondaryOutcomes': [{'measure': 'Ten-meter Walk Test', 'timeFrame': 'Approximately 30 days (difference between admission and discharge)', 'description': '10mWT assesses comfortable walking speed over the distance of 10 meters'}, {'measure': 'Six-minute Walk Test - change', 'timeFrame': 'Approximately 30 days (difference between admission and discharge)', 'description': '6mWT assesses assess aerobic capacity and endurance'}, {'measure': 'Functional Independence Measure - change', 'timeFrame': 'Approximately 30 days (difference between admission and discharge)', 'description': 'FIM is an 18-item two-dimensional instrument that explores physical and psychosocial functioning'}, {'measure': 'EQ-5D-3L - change', 'timeFrame': 'Approximately 30 days (difference between admission and discharge)', 'description': 'EQ-5D-3L is a patient-reported instrument for measuring HRQOL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DEMMI', 'outcome measurement', 'physiotherapy', 'clinimetric properties'], 'conditions': ['Musculoskeletal Diseases']}, 'descriptionModule': {'briefSummary': 'Metric properties (convergent validity, predict validity, known-groups validity, responsiveness, floor and ceiling effects, minimal clinically important difference) of the de Morton Mobility Index (DEMMI) in patients with musculoskeletal impairments undergoing impatient rehabilitation will be investigated.', 'detailedDescription': 'Convergent validity of DEMMI will be assessed in terms of correlations with the other outcome measures. Known-groups validity will be demonstrated by differences in DEMMI scores between patients who were not able to walk and those who were able to walk with or without walking aid. Predictive validity of DEMMI at admission for functional independence at discharge from rehabilitation will be estimated. The minimal clinically important difference of DEMMI, responsiveness and floor or ceiling effects will also be estimated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with musculoskeletal impairments with or without impairments of peripheral nerves', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admission to inpatient rehabilitation\n* written informed consent\n\nExclusion Criteria:\n\n* associated impairments of the central nervous system or other severe health conditions'}, 'identificationModule': {'nctId': 'NCT04762927', 'acronym': 'DEMMIURIS', 'briefTitle': 'Metric Properties of de Morton Mobility Index', 'organization': {'class': 'OTHER', 'fullName': 'University Rehabilitation Institute, Republic of Slovenia'}, 'officialTitle': 'Metric Properties of de Morton Mobility Index in Rehabilitation Patients With Musculoskeletal Impairments', 'orgStudyIdInfo': {'id': 'URIS202101'}}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Rehabilitation Institute, Republic of Slovenia', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Aleksander Zupanc, PT, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Rehabilitation Institute, Republic of Slovenia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Rehabilitation Institute, Republic of Slovenia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}