Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-10 @ 1:38 AM
Study NCT ID:
NCT07272733
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2025-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Detection, Remote Augmented Reality Combined Rehabilitation Therapy, and Translational Therapy for Patients With Chronic Kidney Disease and Cognitive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C048995', 'term': 'ketosteril'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MMSE', 'timeFrame': 'Half a year', 'description': 'Cognitive test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease (Stages 3b-5)', 'Mild Cognitive Disorder']}, 'descriptionModule': {'briefSummary': 'More than half of the patients with nephropathy have cognitive impairment, which can reach the level of dementia.The decline of renal function is more serious. With the aging of the population and changes in lifestyle, the number of patients is increasing day by day. The reasons are 1.Chronic kidney disease is prone to sarcopenia due to restricted protein intake, and even affects the heart and brain other than the kidneys. 2. Often accompanied by limb weakness and inconvenience of movement, sometimes it is very inconvenient to go to the hospital for treatment, so the hospital is the center cardio to perform telerehabilitation therapy is another option, so the purpose of this study is for patients with cognitive impairment Rehabilitation in virtual reality at a distance to evaluate its effectiveness. In this study, we selected from the treatment room of Beijing Medical Rehabilitation Department choose a space, simulate the situation of home telerehabilitation, and implement virtual reality telerehabilitation with the hospital as the center. The effect of distance rehabilitation and traditional rehabilitation. The study is expected to recruit 60 patients with chronic cognitive impairment and kidney disease who will be randomized. Divided into two groups A, B and C for training, 20 patients in each group, of which group A received ketoacid amino acid supplementation therapy, 3 capsules per day for 3 months; patients in group B received telerehabilitation for 30 minutes three days a week for a total of 3 months; C C The group was the control group, and the treatment was carried out according to the medical routine. The 60 patients received cognitive function,Brain functional MRI, balance ability, clinical function, clinical physical data, daily living function and depression Index evaluation. The results of this study can be used as a reference for future home tele-rehabilitation and ketoacid amino acid supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic kidney disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChronic kidney disease stage 3-5\n\nExclusion Criteria:\n\n* without cognitive disorder'}, 'identificationModule': {'nctId': 'NCT07272733', 'briefTitle': 'Early Detection, Remote Augmented Reality Combined Rehabilitation Therapy, and Translational Therapy for Patients With Chronic Kidney Disease and Cognitive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Hospital'}, 'officialTitle': 'Early Detection, Remote Augmented Reality Combined Rehabilitation Therapy, and Translational Therapy for Patients With Chronic Kidney Disease and Cognitive Disorder', 'orgStudyIdInfo': {'id': 'N202208048'}, 'secondaryIdInfos': [{'id': 'NSTC 112-2221-E-038-016', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Science and Technology'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'CKD stage 3-5 Age between 20-85 with mild cognitive disorder', 'interventionNames': ['Drug: Ketosteril']}], 'interventions': [{'name': 'Ketosteril', 'type': 'DRUG', 'description': 'Ketosteril will lower protein binded uremic toxin', 'armGroupLabels': ['CKD stage 3-5 Age between 20-85 with mild cognitive disorder']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}