Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-29 @ 3:19 AM
Study NCT ID:
NCT06232850
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2024-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wrist Position Sense in Individuals With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011434', 'term': 'Proprioception'}], 'ancestors': [{'id': 'D000084323', 'term': 'Vestibulocochlear Physiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-01-22', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wrist Position Sense Assessment', 'timeFrame': 'four mounth', 'description': 'Wrist position sense will be assessed with the KFORCE Sens® electrogoniometer. Target measurement values of 30° for wrist flexion, 30° for extension, 10° for radial deviation and 15° for ulnar deviation will be used.'}], 'secondaryOutcomes': [{'measure': 'Purdue Pegboard Test (PPT)', 'timeFrame': 'four mounth', 'description': 'PPT evaluates the gross motor skills of the arm, hand and fingers, as well as the fine motor skills of the fingers and fingertips, both unilaterally and bilaterally. It consists of pins, washers, nuts and assembly tests. The test consists of 5 sub-steps (inserting pins with the dominant/non-dominant hand/both hands, mathematical summation and assembly). The scoring of the test is the total number of pins, washers and nuts installed at the end of the given period. One trial will be made for each subtest.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Manual Dexterity', 'Position Sense'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'No study has been found examining the effect of wrist position sense on manual dexterity in individuals with multiple sclerosis.The purpose of this study is to examine the effect of wrist position sense on manual dexterity of the hand.', 'detailedDescription': "Multiple sclerosis is a chronic demyelinating disease of the central nervous system that occurs in young adults and usually progresses with attacks and remissions. As the disease progresses, symptoms such as fatigue, muscle weakness, loss of balance, loss of sensation, spasticity, visual disturbances and bladder dysfunction are observed. In addition to these symptoms, hand functions may be affected even in the early stages of the disease.\n\nAppropriate motor control and mobility skills are required to perform manual dexterity effectively. Joint stabilization and perception of the joint's position and movement in space are needed for motor control of hand functions. In this process, position sense signals contribute significantly to the target localization and performance of the hand. Position sense signals must be constantly updated for the coordination and integration of hand position during manual activities such as holding or grasping an object. This is possible with a healthy sense of position.\n\nAlthough it is known that position sense is affected in MS patients, no study has been found examining the effect of wrist position sense on manual dexterity. The purpose of this study is to examine the effect of wrist position sense on hand dexterity. Patients' manual dexterity will be evaluated using the Purdue Pegboard Test, and wrist position sense will be evaluated using the K-FORCE Sens® electrogoniometer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MS and healthy individuals who proper the inclusion and exclusion criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient group:\n\n * Disability score (EDSS: Expanded Disability Status Scale) should be between 0-3.\n * Being between the ages of 18-50\n * Not having had an attack in the last 3 months\n * Scoring 24 points or above on the Mini-Mental State Examination\n * Patients diagnosed with relapsing-remitting MS with a disease duration of at least 2 years\n * Patients without spasticity according to MAS\n\nControl group:\n\n* Volunteers in a similar age range who agreed to participate in the study\n* Being between the ages of 18-50\n\nExclusion Criteria:\n\n* Patient group:\n\n * Presence of diagnosed visual impairment\n * Having other chronic diseases not related to MS\n * Having any orthopedic, neurological, rheumatological or metabolic diagnosis that causes upper extremity involvement\n * History of hand and upper extremity disorders, peripheral nerve disorders, and medical or psychiatric disorders that may significantly affect cognitive function\n * Presence of wrist joint range of motion limitation\n\nControl group:\n\n* Having any orthopedic, neurological, rheumatological or metabolic diagnosis that causes upper extremity involvement\n* History of hand and upper extremity disorders, peripheral nerve disorders, and medical or psychiatric disorders that may significantly affect cognitive function\n* Presence of wrist joint range of motion limitation'}, 'identificationModule': {'nctId': 'NCT06232850', 'briefTitle': 'Wrist Position Sense in Individuals With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Examining the Relationship Between Wrist Position Sense and Manual Dexterity in Individuals With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'PU-FTR-MI-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple sclerosis patient', 'description': 'According to EDSS should be between 0-3, not having had an attack in the last 3 months and without spasticity according to MAS in patient with MS will assesment KFORCE Sens® device and Purdue Pegboard Test.', 'interventionNames': ['Other: Position sense and manual dexterity evaluate']}, {'label': 'Healthy group', 'description': 'Healthy people of similar age who agree to participate in the study will evaluate the KFORCE Sens® device and the Purdue Pegboard Test.', 'interventionNames': ['Other: Position sense and manual dexterity evaluate']}], 'interventions': [{'name': 'Position sense and manual dexterity evaluate', 'type': 'OTHER', 'description': 'Position sense and manual dexterity evaluate', 'armGroupLabels': ['Healthy group', 'Multiple sclerosis patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20160', 'city': 'Denizli', 'state': 'Deni̇zli̇', 'country': 'Turkey (Türkiye)', 'facility': 'Müge içelli güneş', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'Müge İçelli Güneş, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pamukkale University Denizli Health Services Vocational School of Higher Education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'müge içelli', 'investigatorAffiliation': 'Pamukkale University'}}}}