Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 4:09 PM
Study NCT ID:
NCT06048861
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2023-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Joint Position Sense in Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-14', 'studyFirstSubmitDate': '2023-09-07', 'studyFirstSubmitQcDate': '2023-09-14', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint position sense', 'timeFrame': 'Day 1', 'description': "The evaluation of participants' wrist position sense was performed separately with a Baseline® electrogoniometer and KForce Sens®."}, {'measure': 'Joint position sense re-test', 'timeFrame': 'up to 1 week', 'description': "The evaluation of participants' wrist position sense was performed with KForce Sens®."}], 'secondaryOutcomes': [{'measure': 'Function and symptom severity', 'timeFrame': 'Day 1', 'description': 'The Boston Carpal Tunnel Questionnaire included 19 items indicating the severity, frequency, and duration of symptoms and difficulty in performing daily tasks.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['joint position sense', 'electrogoniometer', 'carpal tunnel syndrome'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to investigate the validity and reliability of the KForce Sens® for the evaluation of wrist joint position sense in individuals with CTS. Wrist joint position sense was assessed with KForce Sens® and Baseline® electrogoniometer. The validity and reliability of the KForce Sens® for wrist position sense evaluation were investigated by comparing the two data sets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to moderate CTS confirmed with EMG\n* having symptoms for at least 3 months\n* not receiving medical treatment and physiotherapy until 3 months before the study at the latest\n\nExclusion Criteria:\n\n* having trauma in the affected extremity in the last 6 months\n* having cervical radiculopathy\n* having brachial plexopathy\n* having cognitive problems\n* having neurological problems\n* being pregnant'}, 'identificationModule': {'nctId': 'NCT06048861', 'briefTitle': 'Evaluation of Joint Position Sense in Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Evaluation of Joint Position Sense With Two Different Electrogoniometers in Mild and Moderate Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'E-60116787-020-136447'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individuals with Carpal Tunnel Syndrome', 'interventionNames': ['Device: KForce Sens', 'Device: Baseline Electrıgoniometer']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Controls', 'interventionNames': ['Device: KForce Sens']}], 'interventions': [{'name': 'KForce Sens', 'type': 'DEVICE', 'description': 'The device was attached to the middle of the wrist joint with the help of Velcro for all movements. Starting position of the extremity was determined and this position was introduced to the device as the reference position. Then, the participant was asked to perform the movement.', 'armGroupLabels': ['Healthy Controls', 'Individuals with Carpal Tunnel Syndrome']}, {'name': 'Baseline Electrıgoniometer', 'type': 'DEVICE', 'description': 'The pivot point of the goniometer was placed next to the ulnar styloid for 30° and 60° wrist flexion and extension, and also it was placed in the middle carpometacarpal joint for radial and ulnar deviation. A passive movement was made to the extremity in a predetermined amount and direction. The participant was asked to remember this position. Then, the participant was asked to return the extremity to this position when their eyes were closed.', 'armGroupLabels': ['Individuals with Carpal Tunnel Syndrome']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Sinem Yenil, PT, MSc', 'investigatorAffiliation': 'Pamukkale University'}}}}