Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-29 @ 8:40 AM
Study NCT ID:
NCT06043960
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2023-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Lower Limb Functionality, Foot Joint Position Sensation and Balance in Haemiplegic Patients
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-31', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tecno Body Prokin Isokinetic Balance System', 'timeFrame': 'First Day', 'description': 'It expresses the equilibrium rate and the probability of falling.'}, {'measure': 'CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System', 'timeFrame': 'First day', 'description': 'Measures ankle joint position sensation.'}, {'measure': 'Berg Balance Scale', 'timeFrame': 'First day', 'description': 'It was developed for the evaluation of postural dominance.'}, {'measure': 'Fugl-Meyer Assessment of the lower extremity', 'timeFrame': 'First day', 'description': 'Is used for the assessment of motor function after stroke. The total possible score for the lower limb is 34. The higher the score, the better the performance.'}, {'measure': 'Tinetti Fall Activity Scale', 'timeFrame': 'First day', 'description': 'It measures how confident the individual is in performing some activities of daily living such as reaching shelves, walking around the house, dressing and undressing, and personal care without falling. There is a rating between 1-10. Each question is defined as 1 (very confident), 10 (not confident at all). If the total score is \\>70, there is fear of falling.'}, {'measure': 'Time Up Go Test', 'timeFrame': 'First day', 'description': 'The purpose of the test is to provide an approach to observing gait. The patient is observed and timed while getting up from the chair, walking 3 metres, turning, walking back and sitting again.'}, {'measure': 'Mini Mental Test', 'timeFrame': 'First day', 'description': 'The MMSE (Mini-Mental State Examination) is a 30-question assessment tool commonly used by health professionals to assess cognitive functioning, including elements such as thinking, communication, comprehension and memory, to detect potential disorders.'}, {'measure': 'Romberg Test', 'timeFrame': 'First day', 'description': 'The Romberg sign is a potential indicator of a neurological disorder linked to proprioception, impairing the visual and vestibular elements that are crucial for maintaining balance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Proprioception', 'Lower limb functionality', 'Ankle joint', 'Balance'], 'conditions': ['Being Between 40-80 Years Old', 'Being Diagnosed With Haemiplegia', 'Getting 20 Points or More in the Mini Mental Test', 'Volunteering to Participate in the Study', 'Level 2 or Above According to Functional Ambulation Classification']}, 'descriptionModule': {'briefSummary': 'Stroke is defined as a neurological disorder resulting from acute focal damage to the central nervous system caused by vascular factors, which may include cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage. Postural balance is a critical factor affecting walking and gait performance in the community after stroke. Gait disorders contribute significantly to functional disability in individuals after stroke. These impairments encompass a variety of changes, including muscle weakness in the affected lower limb, resulting in reduced weight bearing on that limb. This results in a slower and less safe gait. Given the impact on gait, functional mobility is also compromised, including daily activities such as sitting, standing, walking, turning and climbing or descending stairs. Proprioception is impaired in a large percentage of individuals following stroke. The presence of proprioception deficits has been identified as an important determinant of unfavourable functional outcomes after stroke, especially in terms of achieving independence in basic activities of daily living and length of hospital stay. In the literature, there are no studies investigating the relationship between ankle position sense and lower extremity functionality with balance and falls using Humac Norm Isokinetic Machine and Tecno Body Prokin Isokinetic Balance System simultaneously.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with haemiplegia after stroke', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals aged 40-80 years\n* Volunteering to participate in the study\n\nExclusion Criteria:\n\n* Being diagnosed with vertigo\n* Having a history of serious neurological diseases such as Parkinson's disease, multiple sclerosis except hemiplegia\n* Having a previous operation for the lower limb\n* Poor co-operation"}, 'identificationModule': {'nctId': 'NCT06043960', 'briefTitle': 'The Relationship Between Lower Limb Functionality, Foot Joint Position Sensation and Balance in Haemiplegic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'The Relationship Between Lower Limb Functionality, Foot Joint Position Sensation and Balance in Haemiplegic Patients', 'orgStudyIdInfo': {'id': 'BAIBÜFTR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Humac Norm İsokinetic Machine', 'type': 'OTHER', 'otherNames': ['Tecno Body Prokin Isokinetic Balance System'], 'description': 'Tecno Body Prokin Isokinetic Balance System CSMI (CYBEX) Humac Norm Isokinetic Testing and Exercise System Romberg Test Mini Mental Test (MMSE) Fugl-Meyer Assessment of the lower limb'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bolu', 'country': 'Turkey (Türkiye)', 'facility': 'Izzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}], 'overallOfficials': [{'name': 'Adnan Demirel', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bolu Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'INVESTIGATOR', 'investigatorFullName': 'Fatma Hale Altınkaya', 'investigatorAffiliation': 'Karabuk University'}}}}