Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT05008302
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2021-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Age and Body Position on Handgrip Strength and Movement Coordination of Upper Limb
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-10', 'studyFirstSubmitDate': '2021-08-10', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum range of movement of the wrist [mm]', 'timeFrame': 'up to 1 week', 'description': 'Hand Tutor allows measurements of the maximum range of motion (ROM).'}, {'measure': 'Frequency of wrist movement (flexion to extension), cycles#/sec', 'timeFrame': 'up to 1 week', 'description': 'The Hand Tutor allows measurements the speed or frequency (i.e., the number of cycles'}, {'measure': 'Frequency of 1st, 2nd, 3rd, 4th, 5th finger movement (flexion to extension), cycles#/sec', 'timeFrame': 'up to 1 week', 'description': 'The Hand Tutor allows measurements the speed or frequency (i.e., the number of cycles'}, {'measure': '1st, 2nd, 3rd, 4th, 5th finger maximum range of motion (ROM), [mm]', 'timeFrame': 'up to 1 week', 'description': 'The Hand Tutor allows measurements of the maximum range of motion (ROM).'}, {'measure': 'Assessment of the grip strength', 'timeFrame': 'up to 1 week', 'description': 'Grip strength, kg (a manual electronic dynamometer (EH 101) was used for grip strength measurement (error of measurement, 0.5 kg/lb)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'age', 'grip strength', 'coordination movement', 'stabilization'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to analyze the importance of the position of the body and the examined upper limb on the parameters of movement coordination and hand grip strength in various age groups of people after a stroke and healthy individuals.', 'detailedDescription': "The aim of this experiment was to analyze the parameters of motor coordination and handshake strength in stroke patients and healthy volunteers in various age groups and selected torso and upper limb positions. Both patients and healthy volunteers were prospectively divided into three age groups: 18-45, 46-60 and 61 and above. Thus, the maximum range of motion (ROM), frequency of wrist and finger movements, and grip strength (dependent variables) were valued in three age groups and different starting positions (independent variables). The Hand Tutor device (MediTouch, Israel) and the electronic manual dynamometer EH 101 (Camry, China) for grip strength measurement (error of measurement, 0.5 kg/lb) were used.\n\nThe Hand Tutor allows measurements of the frequency of movement (i.e., the number of cycles per second, where one cycle represents the movement from flexion to contraction) and the maximum range of movement, which is automatically measured during the frequency test, were performed over time 10 seconds (sensitivity: 0,05 \\[mm\\] of wrist and fingers Ext./Flex), the frequency of movement (motion capture speed: up to 1 \\[m/sec\\]).\n\nThe test consisted of two motor tasks, carried out in two different starting positions: sitting and lying down (supine). During the first examination, the subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was to be examined in adduction, with the elbow bent in the intermediate position between pronation and supination of the forearm. In the supine position, the upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position).\n\nIn each of the starting positions, after putting the glove on, the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed in both analyzed starting positions, after completing the range of motion and speed or frequency tests. The upper extremity tested in stroke patients was the paretic extremity. In healthy subjects, the dominant hand was tested."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:1) patients with ischemic stroke; 2) Trunk Control Test 70-100 points; 3) subjects who were in a state allowing movements of the upper extremity (FMA-UE 40-66 motor function points); 4) muscle tension (MAS 0 -1+); 5) no severe deficits in communication, memory, or understanding; 6) at least 18 years of age.\n\n\\-\n\nExclusion Criteria:1) stroke up to four weeks after the episode, 2) another neurological disease entity 3) lack of trunk stability, 4) no wrist and hand movement, 5) muscle tension (˃2 MAS), 6) high or very low blood pressure, 7) severe deficits in communication, memory, or understanding; dizziness, the malaise of the respondents.\n\nControl group inclusion criteria: 1) the control group consisted of healthy subjects, free from the upper extremity motor coordination disorders; 2) at least 18 years of age.\n\nControl group exclusion criteria: 1) a history of neurologic or musculoskeletal disorders such as carpal tunnel syndrome, tendonitis, stroke, head injury, or other conditions that could affect their ability to active movement and grip hand; 2) severe deficits in communication, memory, or understanding.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05008302', 'briefTitle': 'Age and Body Position on Handgrip Strength and Movement Coordination of Upper Limb', 'organization': {'class': 'OTHER', 'fullName': 'Military Institute od Medicine National Research Institute'}, 'officialTitle': 'Age and Body Position on Handgrip Strength and Movement Coordination of Upper Limb', 'orgStudyIdInfo': {'id': '2/KRN/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'To improve the coordination of the wrist and hand after stroke in three age groups.', 'description': "The test consisted of two motor tasks, carried out in two different starting positions: sitting and lying down (supine). During the first examination, the subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was to be examined in adduction, with the elbow bent in the intermediate position between pronation and supination of the forearm. In the supine position, the upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position).", 'interventionNames': ['Procedure: hand motor coordination in a sitting positin']}], 'interventions': [{'name': 'hand motor coordination in a sitting positin', 'type': 'PROCEDURE', 'otherNames': ['hand motor coordination in a supine position'], 'description': "Before each test, the patient was instructed on how the exercise should be done. The test consisted of two motor tasks, carried out in two different starting positions: sitting and lying down (supine). During the first examination, the subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was to be examined in adduction, with the elbow bent in the intermediate position between pronation and supination of the forearm. In the supine position, the upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position).", 'armGroupLabels': ['To improve the coordination of the wrist and hand after stroke in three age groups.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04-141', 'city': 'Warsaw', 'state': 'Masovian District', 'country': 'Poland', 'facility': 'Anna Olczak', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Anna Olczak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military Institute of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anna Olczak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD; Senior Specjalit of the Rehabilitation Clinc', 'investigatorFullName': 'Anna Olczak', 'investigatorAffiliation': 'Military Institute od Medicine National Research Institute'}}}}