Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-29 @ 11:02 AM
Study NCT ID:
NCT06308250
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2024-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effects of Mime Therapy and Action Observation Therapy in Bell's Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020330', 'term': 'Bell Palsy'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sunny Brook Facial Grading System', 'timeFrame': '6th week', 'description': 'The system includes three components: resting symmetry, the symmetry of voluntary movements, and synkinesis. A composite facial symmetry score is calculated as \\[4 × symmetry of voluntary movement - 5 × resting asymmetry + 1 × synkinesis\\] with 100 representing normal facial symmetry.'}, {'measure': 'Facial Disability Index', 'timeFrame': '6th week', 'description': "it is used to assess the quality of life in patients with bell's palsy. It also helps to measure the difficulties of the face in activities of daily living. It represents the relationship between impairments, disability, and psychosocial status and also focuses on the disability of individuals with disorders of the facial motor system. The individual subscales are scored out of a total of 100 where the highest score is the best result."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bell Palsy', 'Breathing exercise', 'Comparative', 'MIME Protocol', 'Randomized clinical trial'], 'conditions': ['Bell Palsy']}, 'descriptionModule': {'briefSummary': "The aim of this study is to determine comparative effects of mime therapy and action observation therapy on facial symmetry and quality of life in Bell's palsy. Bell's palsy is characterized as an abrupt paralysis of the peripheral facial nerve, typically without a known cause. Mime Therapy is a performing technique that helps patients regain the ability to use their face muscles. Action observation therapy is novel rehabilitation approach exploiting this mirror mechanism.", 'detailedDescription': "This randomized clinical trial will be conducted at Sir Ganga Ram Hospital in 7 months. 62 participants with Bell's palsy will be included as per sample size calculation through convenience sampling technique. Participants which meet inclusion criteria will be randomly allocated using online randomization tool into two groups. Group A will receive Mime therapy for 30 minutes with short resting interval and Group B will receive action observation therapy for 30 minutes. Each group will receive treatment session of 5 days per week for 6 weeks.\n\nFacial symmetry will be measured using the 13-item Sunny Brook facial Grading System, Facial disability index will be used to assess the quality of life and The House-Brackmann Facial Nerve Grading System will be used to characterize the degree of facial paralysis. The data will be analyzed using SPSS version 24 for Windows software."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Bell's Palsy with acute onset of 1-3 weeks.\n2. Unilateral loss of facial weakness.\n3. Patients with intact taste sensation.\n4. Bell's Palsy of House Brackmann grade 3 and 4.\n5. Idiopathic Bell's Palsy.\n\nExclusion Criteria:\n\n1. History of facial palsy recurrence.\n2. Stroke associated Bells palsy.\n3. History of pregnancy\n4. Subjects with any disability, fracture, or tumor.\n5. History of facial surgery.\n6. Subject having skin allergy on face."}, 'identificationModule': {'nctId': 'NCT06308250', 'briefTitle': "Comparative Effects of Mime Therapy and Action Observation Therapy in Bell's Palsy", 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': "Comparative Effects of Mime Therapy and Action Observation Therapy on Facial Symmetry and Quality of Life in Bell's Palsy", 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/23/0294'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP A ( MIME THERAPY)', 'description': 'Group A will receive mime therapy of 30 minutes with short resting intervals. Treatment will be given 5 times per week for 6 weeks. Mime therapy consist of:\n\n1. Self massage of 10 minutes,\n2. Breathing and relaxation exercises of 5 minutes,\n3. Articulation of 5 minutes and\n4. Facial expression exercises of 10 minutes.', 'interventionNames': ['Other: MIME THERAPY']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP B (ACTION OBSERVATION THERAPY)', 'description': 'Group B will receive action observation therapy of 30 minutes with short resting interval. The treatment will be given 5 times per week for 6 weeks.\n\nDuring the presentation of a video clip, patients sit relaxed in front of the computer screen while observing it.\n\nAfter observing a motor act for 3 min (observation phase) patients are required to imitate what they observed for 2 min (execution phase).', 'interventionNames': ['Other: ACTION OBSERVATION THERAPY']}], 'interventions': [{'name': 'MIME THERAPY', 'type': 'OTHER', 'description': 'Mime therapy consist of:\n\nSelf massage: patients will be taught to massage their face and neck daily for about 10 minutes which includes effleurage and kneading of both sides of face.\n\nBreathing exercises: patient will be taught to recognize tension and feel the difference between tension and relaxation in facial musculature for 5 minutes. Expiration exercises will be used to induce relaxation.\n\nArticulation: vowels such as a,e,i,o,u and consonants such as p and b will be used to teach position of the lips for 5 minutes.\n\nFacial expression exercises: forehead wrinkle, smiling, eye closure, frowning, disgust, surprise, anger, sadness will be performed for 10 minutes', 'armGroupLabels': ['GROUP A ( MIME THERAPY)']}, {'name': 'ACTION OBSERVATION THERAPY', 'type': 'OTHER', 'description': 'Function of each of the muscle is observed for 3 minutes and then executed for 2 minutes.\n\nFrontalis (Raising eyebrows and forehead wrinkling). Corrugator Supercili (Moving the eyebrow down and inward toward the nose and inner eye).\n\nOrbicularis oculi (Closing the eyelids). Buccinator (Blowing air in and out of the mouth). Zygomaticus major (Smiling). Orbicularis oris (Lip pursing or puckering).', 'armGroupLabels': ['GROUP B (ACTION OBSERVATION THERAPY)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54660', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Riphah International University', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Muhmmad Kashif, PhD-PT', 'role': 'STUDY_CHAIR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}