Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-01 @ 10:35 PM
Study NCT ID:
NCT02767466
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Affective Responses in Neurological Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], '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'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2016-04-22', 'studyFirstSubmitQcDate': '2016-05-09', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of subscales of mood survey scale from pre to post treatment', 'timeFrame': '30-60 minutes'}]}, 'conditionsModule': {'conditions': ['Neurological Incidents', 'Stroke', 'Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'Using a single blind within-subject design, 16 patients with neurological disorders were randomly exposed to two different treatments: physical therapy and robotic assisted gait training. Both before and after the treatments, a self-report Mood Survey Scale (MSS) was used to assess the effects on the treatment on distinct affective states. The subscales of the MSS were tested for pre-post changes and different effects between treatments with non-parametric tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with neurological disorders', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* voluntary participation\n* neurological incident\n\nExclusion Criteria:\n\n* lack of communication ability\n* interference of consciousness\n* inability to speak German language'}, 'identificationModule': {'nctId': 'NCT02767466', 'briefTitle': 'Affective Responses in Neurological Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Universitaet Innsbruck'}, 'officialTitle': 'A Preliminary Study on Acute Affective Responses Focussing on Differences Between Physical Therapy and Robotic Assisted Gait Training', 'orgStudyIdInfo': {'id': 'APTRAGT001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'G', 'description': "All participants were randomly exposed to two different treatments:\n\n* Conventional physical therapy (no specific device used)\n* Robotic assisted gait training (Lokomat, Hocoma AG, Switzerland)\n\nWe consider the study as observational, since the both interventions of the study (physical therapy, robotic assisted gait training) did not change in the patients' usual therapy plan, as they received both interventions daily.\n\nWe only added diagnostic interventions to assess the affective responses.", 'interventionNames': ['Procedure: Physical therapy and robotic assisted gait training']}], 'interventions': [{'name': 'Physical therapy and robotic assisted gait training', 'type': 'PROCEDURE', 'armGroupLabels': ['G']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Martin Kopp, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Univeryity of Innsbruck'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaet Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Martin Burtscher', 'investigatorFullName': 'Martin Burtscher', 'investigatorAffiliation': 'Universitaet Innsbruck'}}}}