Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-17 @ 3:41 AM
Study NCT ID:
NCT06542302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-25
First Post:
2024-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Cervical Sensorimotor Control Challenges on Gait Patterns, Cervical Sensorimotor Control During Dynamic Tasks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-08-04', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spatiotemporal parameter', 'timeFrame': 'One day', 'description': 'Gait speed (meter/second)'}, {'measure': 'Spatiotemporal parameter', 'timeFrame': 'One day', 'description': 'cadence (steps/minute)'}, {'measure': 'Spatiotemporal parameter', 'timeFrame': 'One day', 'description': 'stride length (meter)'}, {'measure': 'Spatiotemporal parameter', 'timeFrame': 'One day', 'description': 'stride duration (second)'}, {'measure': 'Spatiotemporal parameter', 'timeFrame': 'One day', 'description': 'stance duration (second)'}, {'measure': 'Spatiotemporal parameter', 'timeFrame': 'One day', 'description': 'swing duration (second)'}, {'measure': 'Spatiotemporal parameter', 'timeFrame': 'One day', 'description': 'stance length (meter)'}, {'measure': 'Spatiotemporal parameter', 'timeFrame': 'One day', 'description': 'swing length (meter)'}, {'measure': 'Spatiotemporal parameter', 'timeFrame': 'One day', 'description': 'step width (meter)'}, {'measure': 'Head and Cervical Kinematics', 'timeFrame': 'One day', 'description': 'Mean, range, maximum, and minimum of the angular displacements (degree)'}, {'measure': 'Head and Cervical Kinematics', 'timeFrame': 'One day', 'description': 'Mean and peak angular velocity (m/s) and acceleration (m/\\^2)'}, {'measure': 'Lower Extremity Kinematics and Kinetics', 'timeFrame': 'One day', 'description': 'Maximum, minimum, and range angular displacement (degree of joint angle)'}, {'measure': 'Lower Extremity Kinematics and Kinetics', 'timeFrame': 'One day', 'description': 'Mean and peak angular velocity and acceleration (m/\\^2)'}, {'measure': 'Enter of Mass and Center of Pressure (COM-COP)', 'timeFrame': 'One day', 'description': 'A 15-component link-segment model will be used to estimate the location of the total body COM. The center of pressure (COP) data will be derived from the outputs of the AMTI force platform.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sensorimotor control', 'Chronic neck pain', 'Oculomotor control', 'Gait', 'Balance'], 'conditions': ['Neck Pain', 'Sensorimotor', 'Gait']}, 'descriptionModule': {'briefSummary': 'To investigate the influence of cervical SMC challenges during gait-related dynamic tasks on all task performance and symptoms in patients with CNP.', 'detailedDescription': 'The goal of this observational study is to learn about the immediate effects of cervical sensorimotor challenges during gait-related dynamic tasks on all task performance and symptoms in patients with CNP .\n\nThe main question it aims to answer is:\n\nDoes adding sensorimotor challenges in chronic neck pain patient will affect balance and gait performance?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic neck pain are: (1) pain was unilateral or bilateral between the superior nuchal line and 1st thoracic vertebra, (2) neck pain persisting for 3 months and above, and (3) average pain intensity of last pain episode was between 2 and 8 based on the numeric rating scale (NRS).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy asymptomatic adults will not have any complaints of current pain and impairments of neuromusculoskeletal systems within the last 6 months.\n* For patients with CNP\n\n * Pain was unilateral or bilateral between the superior nuchal line and 1st thoracic vertebra\n * Neck pain persisting for 3 months and above\n * Average pain intensity of last pain episode was between 2 and 8 based on the numeric rating scale (NRS).\n\nExclusion criteria:\n\n◾For patients with CNP and healthy asymptomatic adults\n\n* Acute or the first onset of neck pain\n* Traumatic cause of pain\n* Previous fracture or surgery of the spine\n* Diagnosed cardiopulmonary diseases, for example, chronic obstructive pulmonary disease, pulmonary tuberculosis, asthma, chronic bronchitis, pulmonary emphysema\n* Diagnosed gastrointestinal and abdominal conditions which may interfere daily activities within the past 6 months\n* Medical conditions that may affect balance and study procedures (e.g. neurological diseases, vestibular disorders, malignant tumors)\n* Metabolic diseases such as anemia and diabetes\n* Smoking, plan to pregnant or in pregnancy\n* Psychological disorders (affect questionnaire responses)\n* Unable to walk independently\n* Corrected visual abnormalities or individuals unable to wear contact lenses for vision correction due to the potential interference of wearing VR head-mounted display with glasses.'}, 'identificationModule': {'nctId': 'NCT06542302', 'briefTitle': 'The Effects of Cervical Sensorimotor Control Challenges on Gait Patterns, Cervical Sensorimotor Control During Dynamic Tasks', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng Kung University'}, 'officialTitle': 'Influence of Various Cervical Sensorimotor Control Challenges on Gait Patterns, Cervical Sensorimotor Control, and Dual-Task Performance During Dynamic Gait-related Tasks', 'orgStudyIdInfo': {'id': 'NCKU_Visual Challenge'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Idiopathic neck pain group', 'description': 'Pain was unilateral or bilateral between the superior nuchal line and 1st thoracic vertebra; Neck pain persisting for 3 months and above; Average pain intensity of last pain episode was between 2 and 8 based on the numerical rating scale (NRS).'}, {'label': 'Asymptomatic adult group', 'description': 'Do not have any complaints of current pain and impairments of neuromusculoskeletal systems within the last 6 months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '701', 'city': 'Tainan', 'country': 'Taiwan', 'contacts': [{'name': 'Yi-Ju Tsai, PhD', 'role': 'CONTACT', 'email': 'lulilutsai@gmail.com', 'phone': '+886-6-2353535', 'phoneExt': '5021'}, {'name': 'Yi-Ju Tsai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cheng Kung University', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Yi-Ju Tsai, PhD', 'role': 'CONTACT', 'email': 'yijutsai@mail.ncku.edu.tw', 'phone': '+886-6-2353535', 'phoneExt': '5021'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng Kung University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'YI-JU TSAI', 'investigatorAffiliation': 'National Cheng Kung University'}}}}