Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-31 @ 1:42 PM
Study NCT ID:
NCT06004635
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2023-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of Myotonometry in the Assessment of Mechanical Properties of Thenar Muscles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle tone (Hz)', 'timeFrame': '30 Minutes', 'description': "The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the muscle tone of forearm muscles measurements will be performed and recorded."}, {'measure': 'Stiffness (N/m)', 'timeFrame': '30 Minutes', 'description': "The stiffness which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the stiffness of forearm muscles measurements will be performed and recorded."}, {'measure': 'Elasticity (Logarithmic decrement)', 'timeFrame': '30 Minutes', 'description': "The elasticity which is a viscoelastic property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the stiffness of forearm muscles measurements will be performed and recorded."}], 'secondaryOutcomes': [{'measure': 'Pinch strength', 'timeFrame': '30 Minutes', 'description': 'Pinch grip strength will be assessed using a hydraulic pinchmeter (Baseline). Standard procedures recommended by American Society of Hand Therapists (ASHT) will be followed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rehabilitation', 'biomechanics', 'assessment', 'skeletal muscle'], 'conditions': ['Muscular Tone']}, 'referencesModule': {'references': [{'pmid': '39765426', 'type': 'DERIVED', 'citation': 'Saldiran TC, Schleip R, Tanhan A, Ozturk O, Kara I. Quantifying thenar muscle biomechanical properties: Sex-based variations and implications for grip strength. J Hand Ther. 2025 Jul-Sep;38(3):594-604. doi: 10.1016/j.jht.2024.11.009. Epub 2025 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to (i) assess the reliability of myotonometer measurements in determining the mechanical properties of thenar muscle in healthy individuals and explore gender-based variations in these properties; (ii) examine the relationship between pinch grip strength and these mechanical properties.', 'detailedDescription': 'Investigating the mechanical properties of hand muscles using simple applicable methods such as myotonometer can help to evaluate the effectiveness of programs used in hand rehabilitation, optimize the skills of performance-oriented individuals such as athletes and musicians, and create individualized treatment and training programs. In musculoskeletal-related pathologies such as carpal tunnel syndrome, studying the mechanical properties of the thenar muscles may be important to better understand hand grip strength, hand function and mobility. However, the use of myotonometer in the evaluation of the mechanical properties of the thenar muscles requires a reliability study. Accordingly, the aims of our study are: to (i) assess the reliability of myotonometer measurements in determining the mechanical properties of thenar muscle in healthy individuals and explore gender-based variations in these properties; (ii) examine the relationship between pinch grip strength and these mechanical properties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults between 18-35 years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* being between 18 and 35 years of age\n* having normal upper extremity function\n* having a Montreal Cognitive Assessment Test (MoCA) score \\> 26 points\n\nExclusion criteria:\n\n* any neuromuscular or musculoskeletal disease\n* history of upper limb injury\n* upper limb surgery within the last 6 months\n* body mass index (BMI) \\> 30 kg/m2.'}, 'identificationModule': {'nctId': 'NCT06004635', 'briefTitle': 'Reliability of Myotonometry in the Assessment of Mechanical Properties of Thenar Muscles', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Reliability and Sex-Based Variations in Myotonometer Assessment of Thenar Muscle Properties: Implications for Grip Strength', 'orgStudyIdInfo': {'id': 'BEU-KTS-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '13000', 'city': 'Bitlis', 'country': 'Turkey (Türkiye)', 'facility': 'Bitlis Eren University', 'geoPoint': {'lat': 38.40115, 'lon': 42.10784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ilke KARA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Co-Principal Investigator', 'investigatorFullName': 'Ilke KARA', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}