Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT05251558
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Telerehabilitation Based Exercises in Patients With Bell's Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020330', 'term': 'Bell Palsy'}, {'id': 'D005158', 'term': 'Facial Paralysis'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069350', 'term': 'Telerehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-02-13', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FDI', 'timeFrame': 'Change from Baseline FDI at 4 weeks', 'description': 'The Facial Disability Index is a questionnaire that provides information about the impact of facial paralysis and the physical and social well-being impairment it causes. FDI is scored from 0 to 100. Higher scores indicate better function.'}, {'measure': 'FaCE', 'timeFrame': 'Change from Baseline FaCE at 4 weeks', 'description': 'It consists of 15 items with responses on a 5-point Likert scale in 6 sub-categories: facial movements, social function, facial comfort, tear control, eye comfort, and mouth function. FaCE is scored from 0 to 100. Higher scores indicate better function.'}, {'measure': 'SF-12', 'timeFrame': 'Change from Baseline SF-12 at 4 weeks', 'description': 'SF 12 is a self-evaluation scale. It consists of seven items. SF-12 is scored from 0 to 100. Higher scores indicate better quality of life.'}, {'measure': 'HADS', 'timeFrame': 'Change from Baseline HADS at 4 weeks', 'description': 'The scale includes anxiety and depression subscales. The purpose of the scale is not to diagnose, but to determine the risk group by scanning anxiety and depression in a short time in patients with physical illness. HADS is scored from 0 to 21. Higher scores indicate higher depression and anxiety.'}, {'measure': 'H-B', 'timeFrame': 'Change from Baseline H-B at 4 weeks', 'description': 'The scale evaluates the four facial regions separately and also assesses the presence of synkinesis. H-B is scored from 4 to 24. Higher scores indicate worse clinical status.'}], 'secondaryOutcomes': [{'measure': 'TSUQ', 'timeFrame': 'Change from Baseline TSUQ at 4 weeks', 'description': 'With this survey, the satisfaction levels and usability of individuals using the telemedicine service are evaluated. TSUQ is scored from 21 to 105. Higher scores indicate higher satisfaction and usability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bells Pasly', 'Telerehabilitation', 'Peripheral Facial Paralysis', 'Proprioceptive Neuromuscular Facilitation'], 'conditions': ['Bell Palsy']}, 'descriptionModule': {'briefSummary': "The study will be carried out with volunteer patients who are diagnosed with Bell's Palsy and comply with the study criteria.The aim of the study is to compare the home PNF exercise program with video-based telerehabilitation and the conventional training program in terms of outcome measures in patients with Bell's Palsy lesions.", 'detailedDescription': "With the telerehabilitation program, it is aimed that patients can easily adapt to home exercise programs and be followed up remotely. In this way, the most effective treatment of the disease will provide the patient with both motor function gain and psychosocial gain. This study was planned to examine the effectiveness of telerehabilitation in patients with Bell's Palsy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female patients aged 18 - 65 years\n* Being diagnosed with Bell's Palsy by a specialist physician\n* Having a lower motor neuron lesion\n* Non-traumatic cases\n* Not having any other neurological deficits\n* Having signed the consent form\n\nExclusion Criteria:\n\n* Situations that will prevent assessments or communication with the individual\n* Bilateral involvement\n* Having an operation for facial palsy\n* Having an upper motor neuron lesion\n* Neurological problems that would preclude evaluation and/or treatment."}, 'identificationModule': {'nctId': 'NCT05251558', 'briefTitle': "Efficacy of Telerehabilitation Based Exercises in Patients With Bell's Palsy", 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': "The Efficacy of Telerehabilitation Based Self Proprioceptive Neuromuscular Facilitation Exercises on Clinical and Psychosocial Parameters in Bell's Palsy Patients", 'orgStudyIdInfo': {'id': 'BELLS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation (TR)', 'description': 'Self PNF exercises determined for facial muscles (M. Frontalis, M. Orbicularis Oculi, M. Orbicularis Oris, M. Risorius etc.) will be applied.', 'interventionNames': ['Other: Telerehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Education Program (CEP)', 'description': "Education will be given to cases with Bell's Palsy. Some exercises will be suggested in front of the mirror. Patients will be advised to gently massage upwards with their fingertips after applying a warm towel with a towel on the facial muscles.", 'interventionNames': ['Other: Conventional Education Program']}], 'interventions': [{'name': 'Telerehabilitation', 'type': 'OTHER', 'description': 'The telerehabilitation platform is used to deliver the home exercise program.', 'armGroupLabels': ['Telerehabilitation (TR)']}, {'name': 'Conventional Education Program', 'type': 'OTHER', 'description': 'The patient is given education about the points to be considered for the disease and the exercises to be applied.', 'armGroupLabels': ['Conventional Education Program (CEP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48000', 'city': 'Muğla', 'state': 'Menteşe', 'country': 'Turkey (Türkiye)', 'facility': 'Mugla Sıtkı Kocman University Hospital Emergency Service', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'overallOfficials': [{'name': 'Fatih Özden, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Muğla Sıtkı Koçman University'}, {'name': 'Mehmet Özkeskin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University'}, {'name': 'İsmet Tümtürk, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Süleyman Demirel University'}, {'name': 'Yalçın Gölcük, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muğla Sıtkı Koçman University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fatih Ozden', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}}