Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-02 @ 4:07 AM
Study NCT ID:
NCT05836792
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2023-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cycle Ergometer With Biofeedback on Deep Sensation in Elderly Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D012678', 'term': 'Sensation Disorders'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2023-04-19', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diapason survey', 'timeFrame': '3 weeks', 'description': 'Diapason will be used to survey vibration sense to evaluate deep sensation'}, {'measure': 'Digital Goniometer', 'timeFrame': '3 weeks', 'description': 'Digital Goniometer will be used to measure angle of the knee position to evaluate deep sensation.'}, {'measure': '6 Minute Walking Test (6MWT)', 'timeFrame': '3 weeks', 'description': 'Six Minute walking test will be used to evaluate functional capacity of volunteers'}], 'secondaryOutcomes': [{'measure': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'timeFrame': '3 weeks', 'description': 'WOMAC is a patient-reported outcome measure for the assessment of lower limb osteoarthritis'}, {'measure': 'Physical Activity Scale for the Elderly (PASE)', 'timeFrame': '3 weeks', 'description': 'Physical Activity Scale for the Elderly (PASE) will be used to evaluate the physical activities of individuals. Higher scores show the higher physical activity level.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee Osteoarthritis', 'Deep Sensation', 'Cycle Ergometer', 'Biofeedback'], 'conditions': ['Knee Osteoarthritis', 'Sensation Disorders']}, 'descriptionModule': {'briefSummary': 'The aim of the randomized controlled study is to investigate the effects of the cycle ergometer with biofeedback on deep sensation in elderly people who has knee osteoarthritis', 'detailedDescription': 'Participants will be randomly divided and registered into 2 groups: Thera-train tigo group (TG) or control group(CP)\n\nFor 20 participants 20 minute tens, 5 minute ultrasound, 10 times with 2 sets quadriceps isometric exercise will be applied. The other 20 participants will use Thera-train tigo for 20 minute in addition to tens, us, quadriceps isometric exercise.\n\nConditions of the participants will be measured before(1st day) and after(15th day) a span of 3 week treatment. We will use Demographic Information Questionnaire, Western Ontario and McMaster Universities (WOMAC) osteoarthritis index, Physical Activity Scale for the Eldery (PASE) and 6 minute walking test for all patients. Then we will measure knee vibration sense with diapason. Knee joint position sense will be measured with a digital goniometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nKnee osteoarthritis (Kellgren-Lawrance score between 1-3)\n\nExclusion Criteria:\n\n* Previous knee surgery\n* Diabetus Mellitus\n* Thyroid disease\n* Visual deficit\n* Gait disorder\n* Mental Disability\n* Presence of neuropathy'}, 'identificationModule': {'nctId': 'NCT05836792', 'briefTitle': 'The Effect of Cycle Ergometer With Biofeedback on Deep Sensation in Elderly Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University'}, 'officialTitle': 'The Effect of Cycle Ergometer With Biofeedback on Deep Sensation in Elderly Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '20203034001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cycle Ergometer Group (CEG)', 'description': 'Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer', 'interventionNames': ['Other: Cycle Ergometer', 'Device: Transcutaneous electrical nerve stimulation', 'Device: Ultrasound', 'Other: Isometric exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound', 'interventionNames': ['Device: Transcutaneous electrical nerve stimulation', 'Device: Ultrasound', 'Other: Isometric exercises']}], 'interventions': [{'name': 'Cycle Ergometer', 'type': 'OTHER', 'description': 'Patients will attend cycle ergometer exercise. Volunteers will monitor their pedaling forces as right and left force. They will try to make these forces equal while they are pedaling.', 'armGroupLabels': ['Cycle Ergometer Group (CEG)']}, {'name': 'Transcutaneous electrical nerve stimulation', 'type': 'DEVICE', 'otherNames': ['TENS'], 'description': 'Transcutaneous electrical nerve stimulation will be used for the reduction of pain. TENS will be used 5 times in a week for 3 weeks. Each procedure will take 20 minutes.', 'armGroupLabels': ['Control Group', 'Cycle Ergometer Group (CEG)']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'otherNames': ['US'], 'description': 'Ultrasound will be used for increase the permeability of cells to treat pain and inflammation. US will be used 5 times in a week for 3 weeks. Each procedure will take 5 minutes', 'armGroupLabels': ['Control Group', 'Cycle Ergometer Group (CEG)']}, {'name': 'Isometric exercises', 'type': 'OTHER', 'description': 'The aim of the isometric exercises is increasing muscle strength. Each session patients will do quadriceps isometric exercises 5 times in a week for 3 weeks', 'armGroupLabels': ['Control Group', 'Cycle Ergometer Group (CEG)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Kadıköy', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gülseren Akyüz, Professor', 'role': 'CONTACT', 'email': 'gulserena@gmail.com'}], 'facility': 'Sante Medical Center', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Nilay Aral, Licence', 'role': 'CONTACT', 'email': 'nilayaral@gmail.com', 'phone': '+905344805231'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nilay Aral', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sante Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Nilay Aral', 'investigatorAffiliation': 'Yeditepe University'}}}}