Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 12:16 PM
Study NCT ID:
NCT06756958
Status:
TERMINATED
Last Update Posted:
2025-01-03
First Post:
2024-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Validity of Pittsburgh Rehabilitation Participation Scale During Robot Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The researcher, who recruit, resigned.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-30', 'studyFirstSubmitDate': '2024-11-10', 'studyFirstSubmitQcDate': '2024-12-30', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh Rehabilitation Participation Scale', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'Pittsburgh Rehabilitation Participation Scale could be 1 (none), 2, 3, 4, 5, or 6 (excellent).\n\nExcellent (6): If the patient participated in all exercises or activities with maximal effort, finished all exercises or activities, and actively took interest in exercises or activities and/or future therapy sessions.\n\nNone (1): patient refused entire session, or did not participate in any exercises or activities in session.\n\nIn this study, a participant typically gets 12 sessions of robot assisted gait training. Just after the each session, Pittsburgh Rehabilitation Participation Scale is assigned as 1 to 6.\n\nFor example, in a virtual case, the participant gets the score of 1, 1, 2, 2, 3, 3, 4, 4, 5, 5, 6, and 6 (median =3.5). the participant gets 12 numbers of outcome score and median of Pittsburgh Rehabilitation Participation Scale.'}], 'secondaryOutcomes': [{'measure': 'modified Barthel Index', 'timeFrame': 'baseline and 4 weeks from baseline', 'description': 'Modified Barthel Index measures basic activities of daily life. Lowest score is zero and means no function. Highiest score is 100, best function.'}, {'measure': '10m walk', 'timeFrame': 'baseline and 4 weeks from baseline'}, {'measure': 'Borg scale', 'timeFrame': 'baseline and 4 weeks from baseline', 'description': 'Borg scale measures perceived exertion during the test. It ranges 13 to 20. 13 means easy. 20 means hardest.'}, {'measure': '6 min walk', 'timeFrame': 'baseline and 4 weeks from baseline'}, {'measure': 'motricity index', 'timeFrame': 'baseline and 4 weeks from baseline'}, {'measure': 'Berg balance scale', 'timeFrame': 'baseline and 4 weeks from baseline', 'description': 'Berg balance scale is the combination of 16 5-point-Likert-scale-like ordinal scale of 0 to 4.\n\nO means no balance. 56 means the maximal balance as the criteria.'}, {'measure': 'Trunk impairment scale', 'timeFrame': 'baseline and 4 weeks from baseline', 'description': 'Scores range from a minimum of 0 to a maximum of 23. Zero means no balance. 23 means maximal balance and trunk function.'}, {'measure': 'Function in sitting test', 'timeFrame': 'baseline and 4 weeks from baseline'}, {'measure': 'Modified Rankin Scale for Neurologic Disability', 'timeFrame': 'baseline and 4 weeks from baseline', 'description': 'Modified Rankin Scale for Neurologic Disability could be 0, 1, 2, 3, 4, 5, or 6.\n\nZero (0) means no negative symptoms et al as the criteria. 6 means means dead condition (death) as the criteria.'}, {'measure': 'Functional Ambulatory Category', 'timeFrame': 'baseline and 4 weeks from baseline'}, {'measure': 'Timed Timed Up and Go test', 'timeFrame': 'baseline and 4 weeks from baseline'}, {'measure': 'Manual Muscle Testing', 'timeFrame': 'baseline and 4 weeks from baseline'}, {'measure': 'modified Ashworth scale', 'timeFrame': 'baseline and 4 weeks from baseline', 'description': 'Modified Ashworth scale could be 0, 1, 1+, 2, 3, or 4. Zero (0) means no spasticity as the criteria. 4 means means maximal spasticity as the criteria.'}, {'measure': 'National Institutes of Health Stroke Scale', 'timeFrame': 'baseline and 4 weeks from baseline', 'description': '0 to 24 points. Zero (0) means no deficits as the criteria. 24 means means maximal deficits as the criteria.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['participation', 'robot', 'scale', 'rehabilitation'], 'conditions': ['Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://nrc.go.kr', 'label': 'Description site of the present study'}]}, 'descriptionModule': {'briefSummary': 'Reliability and validity of Pittsburgh Rehabilitation Participation Scale during robot therapy among patients with stroke'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those who participated the tethered-robot assisted gait training, had the history of brain lesion and adimitted in the rehabilitation center.\n\nThose who gave the informed consent about this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with stroke or traumatic brain injury\n* inpatient in rehabilitation center\n\nExclusion Criteria:\n\n* brain tumor\n* spinal cord injury'}, 'identificationModule': {'nctId': 'NCT06756958', 'briefTitle': 'Reliability and Validity of Pittsburgh Rehabilitation Participation Scale During Robot Therapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Rehabilitation Center, Seoul, Korea'}, 'officialTitle': 'Reliability and Validity of Pittsburgh Rehabilitation Participation Scale During Robot Therapy Among Patients with Stroke', 'orgStudyIdInfo': {'id': 'NRC-2017-04-037'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention (observational study)', 'type': 'OTHER', 'description': 'No intervention (observational study: The study participants were inpatient and were given robot-assisted gait training routinely.)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01022', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'National Rehabilitation Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '142884', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Jung Hwan Kim', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Rehabilitation Center, Seoul, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Team manager', 'investigatorFullName': 'Kim, Jung Hwan', 'investigatorAffiliation': 'National Rehabilitation Center, Seoul, Korea'}}}}