Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 8:36 AM
Study NCT ID:
NCT04886466
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2021-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Importance of Core Stability for Coordinated Movement of the Human Body in Stroke Rehabilitation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089944', 'term': 'Core Stability'}], 'ancestors': [{'id': 'D004856', 'term': 'Postural Balance'}, {'id': 'D011434', 'term': 'Proprioception'}, {'id': 'D000084323', 'term': 'Vestibulocochlear Physiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-13', 'studyFirstSubmitDate': '2021-05-10', 'studyFirstSubmitQcDate': '2021-05-10', 'lastUpdatePostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of active movement of the trunk in frontal plane.', 'timeFrame': 'up to 1 week', 'description': 'The range of trunk inclination in the frontal plane (m) was measured using a millimeter board, laser pointer, rangefinder (measurement/angle of inclination accuracy of ± 1.5 mm).'}, {'measure': 'Range of active movement of the trunk in sagittal plane.', 'timeFrame': 'up to 1 week', 'description': 'The range of trunk inclination in the sagittal plane (mm) was measured using a millimeter board, laser pointer, rangefinder (measurement/angle of inclination accuracy of ± 1.5 mm).'}, {'measure': 'The duration of the march-in-place', 'timeFrame': 'up to 1 week', 'description': 'Time measured for 20 steps using the stopwatch'}, {'measure': 'Elevation of the feet', 'timeFrame': 'up to 1 week', 'description': 'The elevation of the feet were measured using the laser pointer, rangefinder (measurement/angle of inclination accuracy of ± 1.5 mm).'}, {'measure': 'The reaction of the multifidus, transverse abdominal, and supraspinatus muscles.', 'timeFrame': 'up to 1 week', 'description': 'The reaction of muscles (tension values reported in microvolts \\[µV\\]) was measured using an electrode, and a device for measuring the voltage of selected muscle groups, Luna EMG (accuracy of measurement \\[-1-+1V+/-1mV\\]).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'core stability', 'muscle tone', 'motor coordination'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '35040753', 'type': 'DERIVED', 'citation': 'Olczak A. Importance of core stability for coordinated movement of the human body in stroke rehabilitation. Neurol Res. 2022 Jan;44(1):7-13. doi: 10.1080/01616412.2021.1950952. Epub 2021 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational study. Measurements were made during two different motor tasks: trunk tilts without and with the tension of the abdominal muscles in the sitting position and walking in a place with high knee lifting. It was checked how the intervention (active tension of the muscles stabilizing the core) changes the parameters of the motor coordination of the trunk and lower limbs.', 'detailedDescription': 'Surface electrodes (single-use 55 and 40 mm; ECG Electrodes; Sorimex, Poland) were glued to the subject\'s body according to the SENIAM (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) procedure for the transverse abdominal, multifidus, and supraspinal muscles, and a laser rangefinder was attached to the dorsal side at chest height. Before each exercise, the subject was instructed on how the exercise should be done.\n\nThe examination involved two motor exercises. In the first one, the subject was seated on the therapeutic table (with their upper extremities crossed over their chest) and instructed to lean forward as far as possible (ideally to place their torso on their thighs) and then quickly return to their starting position. The movement was repeated three times. Then the subject performed three more repetitions of the movement with their core engaged (i.e., their abdominal muscles contracted or "stabilized"). The range of trunk inclination in the sagittal plane (mm) and in the frontal plane (m), and the reaction of the multifidus, transverse abdominal, and supraspinatus muscles (tension values reported in microvolts \\[µV\\]) were measured using a millimeter board, laser pointer, rangefinder (measurement/angle of inclination accuracy of ± 1.5 mm), electrode, and a device for measuring the voltage of selected muscle groups, Luna EMG (accuracy of measurement \\[-1-+1V+/-1mV\\]).\n\nThe second exercise was a march-in-place with a high elevation of the knees. This exercise was also done as quickly as possible (time measured for 20 steps in place in seconds \\[s\\]). The exercise was done in duplicate. On the second occasion, subjects were instructed to do the exercise with their core engaged (i.e., their abdominal muscles contracted or "stabilized"). The exercise was performed in duplicate. The duration of the march and the elevation of the feet were measured, as well as the activity of the multifidus, transverse abdominal, and supraspinatus muscles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '83 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Main criteria for stroke group inclusion: 1) patients with ischemic stroke; 2) patients with hemiparesis after 5 to 7 week after stroke; 3) subjects with stable trunk (the Trunk Control Test 70-100 points); 4) subjects who were in a functional state allowing walking (Rankin Scale ≤ 3); 5) no severe deficits in communication, memory, or understanding what can impede proper measurement performance; 6) at least 22 years of age; maximum 83 years of age.\n\nMain criteria for stroke group exclusion: 1) stroke up to five weeks after the episode, 2) epilepsy, 3) lack of trunk stability, 4) lack of independent walking, 5) high or very low blood pressure, dizziness, malaise.\n\nMain criteria for control group inclusion: 1) the control group consisted of subjects with stable trunk (TCT 100 points); correct muscle tension (MAS 0), independent walking; 2) at least 22 years of age; maximum 83 years of age.\n\nCriteria for control group exclusion: 1) a history of neurologic or musculoskeletal disorders such as stroke or brain injury or other conditions that could affect their ability to active movement the trunk and the legs; 2) back pain; 3) no severe deficits in communication, memory, or understanding what can impede proper measurement performance; 4) high or very low blood pressure, dizziness, malaise.'}, 'identificationModule': {'nctId': 'NCT04886466', 'briefTitle': 'Importance of Core Stability for Coordinated Movement of the Human Body in Stroke Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Military Institute od Medicine National Research Institute'}, 'officialTitle': 'Importance of Core Stability for Coordinated Movement of the Human Body in Stroke Rehabilitation', 'orgStudyIdInfo': {'id': '1/KRN/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The trunk movement coordinated and legs coordination during walking in place.', 'description': 'The intervention (active tension of the muscles stabilizing the core) was tested in post-stroke patients (study group).', 'interventionNames': ['Procedure: core stability in a sitting position and while walking in one place']}, {'type': 'EXPERIMENTAL', 'label': 'The coordinated movement of the trunk and legs during fast walking in place.', 'description': 'The intervention (active tension of the muscles stabilizing the core) was tested in patients with back pain syndrome, but without neurological deficits (control group).', 'interventionNames': ['Procedure: core stability in a sitting position and while walking in one place']}], 'interventions': [{'name': 'core stability in a sitting position and while walking in one place', 'type': 'PROCEDURE', 'description': 'The intervention consisted of checking how the active tension of the multisection and transverse abdominal muscles affects the pattern of the trunk movement (in the sitting position) and the work of the lower limbs and the speed of movement while walking in a place.', 'armGroupLabels': ['The coordinated movement of the trunk and legs during fast walking in place.', 'The trunk movement coordinated and legs coordination during walking in place.']}]}, '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': 'Rehabilitation Clinic, Military Institute of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anna Olczak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ph.D.; senior specjalit of the Rehabilitation Clinc', 'investigatorFullName': 'Anna Olczak', 'investigatorAffiliation': 'Military Institute od Medicine National Research Institute'}}}}