Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-30 @ 10:09 PM
Study NCT ID:
NCT06335095
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2023-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gait Analysis and Degenerative Spine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in gait parameter - speed (m/s) - at 3 months', 'timeFrame': '3 months', 'description': 'The change will be defined by a 10% increase in speed (meters/second) at 3 months from baseline assessment.'}, {'measure': 'Change from baseline in gait parameter - speed (m/s) - at 6 months', 'timeFrame': '6 months', 'description': 'The change will be defined by a 10% increase in speed (meters/second) at 6 months from baseline assessment.'}, {'measure': 'Change from baseline in gait parameter - speed (m/s) - at 12 months', 'timeFrame': '12 months', 'description': 'The change will be defined by a 10% increase in speed (meters/second) at 12 months from baseline assessment.'}, {'measure': 'Change from baseline in gait parameter - step length (m) - at 3 months', 'timeFrame': '3 months', 'description': 'The change will be defined by a 10% increase in step length (meters) at 3 months from baseline assessment.'}, {'measure': 'Change from baseline in gait parameter - step length (m) - at 6 months', 'timeFrame': '6 months', 'description': 'The change will be defined by a 10% increase in step length (meters) at 6 months from baseline assessment.'}, {'measure': 'Change from baseline in gait parameter - step length (m) - at 12 months', 'timeFrame': '12 months', 'description': 'The change will be defined by a 10% increase in step length (meters) at 12 months from baseline assessment.'}, {'measure': 'Change from baseline in gait parameter - step width (m) - at 3 months', 'timeFrame': '3 months', 'description': 'The change will be defined by a 10% decrease in step width (meters) at 3 months from baseline assessment.'}, {'measure': 'Change from baseline in gait parameter - step width (m) - at 6 months', 'timeFrame': '6 months', 'description': 'The change will be defined by a 10% decrease in step width (meters) at 6 months from baseline assessment.'}, {'measure': 'Change from baseline in gait parameter - step width (m) - at 12 months', 'timeFrame': '12 months', 'description': 'The change will be defined by a 10% decrease in step width (meters) at 12 months from baseline assessment.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months', 'timeFrame': '3 months', 'description': 'The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).'}, {'measure': 'Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months', 'timeFrame': '6 months', 'description': 'The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).'}, {'measure': 'Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months', 'timeFrame': '12 months', 'description': 'The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points).'}, {'measure': 'Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months', 'timeFrame': '3 months', 'description': 'The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in ODI (range: 0-50 and higher scores are indicative of more disability).'}, {'measure': 'Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months', 'timeFrame': '6 months', 'description': 'The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in ODI (range: 0-50 and higher scores are indicative of more disability).'}, {'measure': 'Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months', 'timeFrame': '12 months', 'description': 'The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in ODI (range: 0-50 and higher scores are indicative of more disability).'}, {'measure': 'Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months', 'timeFrame': '3 months', 'description': 'Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months'}, {'measure': 'Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months', 'timeFrame': '6 months', 'description': 'Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months'}, {'measure': 'Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months', 'timeFrame': '12 months', 'description': 'Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months'}, {'measure': 'Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months', 'timeFrame': '3 months', 'description': 'In the core COMI-back, 1 question consists of 2 numerical rating scales to be answered from 0 to 10 and 5 questions to be answered by selecting 1 of 5 response options. The average of the 2 disability scores forms the disability dimension subscore. A total COMI score is determined by averaging the 5 dimension scores.'}, {'measure': 'Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months', 'timeFrame': '6 months', 'description': 'In the core COMI-back, 1 question consists of 2 numerical rating scales to be answered from 0 to 10 and 5 questions to be answered by selecting 1 of 5 response options. The average of the 2 disability scores forms the disability dimension subscore. A total COMI score is determined by averaging the 5 dimension scores.'}, {'measure': 'Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months', 'timeFrame': '12 months', 'description': 'In the core COMI-back, 1 question consists of 2 numerical rating scales to be answered from 0 to 10 and 5 questions to be answered by selecting 1 of 5 response options. The average of the 2 disability scores forms the disability dimension subscore. A total COMI score is determined by averaging the 5 dimension scores.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. The main questions it aims to answer are:\n\n* What are the biomechanical variables affected by the disease\n* How they evolve with disease progression and treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with confirmed diagnosis of the spinal disease in study and that meet the eligibility criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 50 and 85 years\n* Diagnosis of spinal disease by clinical and imagiological criteria\n* More than 3 months duration of disease\n* Ability to give consent\n* Fluent portuguese speaker\n\nExclusion Criteria:\n\n* Previous spine surgery\n* Spinal instability\n* Neurological disease that might interfere with walking\n* Known orthopedic conditions that causes significant gait impairment\n* Dementia or development disorder with cognitive impairment\n* Inability to give consent'}, 'identificationModule': {'nctId': 'NCT06335095', 'briefTitle': 'Gait Analysis and Degenerative Spine', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Nova de Lisboa'}, 'officialTitle': 'Gait Analysis and Degenerative Spine', 'orgStudyIdInfo': {'id': 'a319'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Healthy volunteers', 'interventionNames': ['Other: Kinematic sensors']}, {'label': 'Disease', 'interventionNames': ['Other: Kinematic sensors']}], 'interventions': [{'name': 'Kinematic sensors', 'type': 'OTHER', 'description': 'Comparative analysis of kinematic data acquired in supervised and unsupervised environment', 'armGroupLabels': ['Control', 'Disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Nuno Cristino', 'role': 'CONTACT', 'phone': '+351919484946'}], 'facility': 'Hospital da Luz Setúbal', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'centralContacts': [{'name': 'Nuno A.R. Cristino', 'role': 'CONTACT', 'email': 'nuno.cristino.ext@nms.unl.pt', 'phone': '+351217104400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Nova de Lisboa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}