Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-01 @ 12:39 PM
Study NCT ID:
NCT07026032
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2025-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Biofeedback Exercises on Severity of Dysphagia in Parkinson's Clients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The participant will not be aware of the treatment protocol used for their comparison group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups will be made. Group A and Group B. One group will have traditional exercises and the other will have exercises using the Biofeedback.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FOIS', 'timeFrame': '3 Weeks', 'description': 'FOIS is a clinical tool used to assess the functional oral intake of food and liquids in patients with dysphagia. It is a 7-point observer rating clinical scale that was developed to document changes in functional oral intake of liquid and food in stroke patients. FOIS was used for baseline evaluation and post assessment of Experimental and Control group.\n\nThe experimental group demonstrated a notable increase in FOIS scores, improving from 4 ± 1 at baseline to 6 ± 0 at post-assessment. This indicates significant improvements in swallowing behavior associated with the biofeedback method.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson'], 'conditions': ['Oropharyngeal Dysphagia']}, 'descriptionModule': {'briefSummary': "A randomized control trial will be conducted to test if there will be a significant effect or not, of biofeedback exercises vs traditional exercises for clients with oropharyngeal dysphagia in Parkinson's disease. For this purpose, 32 participants will be taken for the study. Half will be given traditional exercises where as the other half will be given exercises using the biofeedback; tongueomter.", 'detailedDescription': "An RCT will be conducted on 32 Parkinson's patients having oropharyngeal dysphagia. FOIS and biofeedback will be used as a baseline instrument to determine the tongue strength and severity of dysphagia at the initial level of the study. The experimental group will perform tongue isometric pressure exercises using biofeedback for twelve sessions, four sessions per week. The control group will perform only traditional tongue-strengthening exercises for twelve sessions, four sessions per week. Both groups will receive therapy for 30 minutes. Both groups will undergo twelve sessions of exercises, starting after a baseline evaluation. Each patient will receive therapy for 30 minutes and have four sessions of therapy weekly. Two exercise protocols will be used. Protocol A will involve biofeedback strengthening exercises using the tongueometer. Protocol B will involve traditional tongue exercises to improve coordination and strength in tongue movement. The experimental group will be instructed to perform Protocol A while the control group will be instructed to perform Protocol B. Each group after randomization will undergo twelve sessions of exercises and baseline assessment will be taken at initial, middle, and final levels."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed cases of Parkinson disease\n* Diagnosed patients of oropharyngeal dysphagia with both genders\n\nExclusion Criteria:\n\n* Cognitive impairment'}, 'identificationModule': {'nctId': 'NCT07026032', 'briefTitle': "Effects of Biofeedback Exercises on Severity of Dysphagia in Parkinson's Clients", 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': "Effects of Biofeedback Exercises on Severity of Dysphagia in Parkinson's Clients", 'orgStudyIdInfo': {'id': 'REC/01763 Gulalai Shafiq Khan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parkinson with dysphagia', 'description': "Diagnosed cases of Parkinson's disease having oropharyngeal dysphagia were taken. The experimental group received exercises through biofeedback.", 'interventionNames': ['Other: Biofeedback tool']}, {'type': 'OTHER', 'label': 'Parkinson with Dysphagia', 'description': 'The second group, that was the control group received traditional tongue exercises.', 'interventionNames': ['Other: Biofeedback tool', 'Other: traditional exercises']}], 'interventions': [{'name': 'Biofeedback tool', 'type': 'OTHER', 'description': 'Biofeedback tool (tongueometer) will be used for experimental group, where as for control group the intervention used in traditional exercises.', 'armGroupLabels': ['Parkinson with Dysphagia', 'Parkinson with dysphagia']}, {'name': 'traditional exercises', 'type': 'OTHER', 'description': 'traditional exercises were used for the control group', 'armGroupLabels': ['Parkinson with Dysphagia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Fauji Foundation Hospital', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Maryam Nadir', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}