Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT02673294
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2016-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronicity Dependence of a Balance Training in Adults Post-stroke
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-03', 'studyFirstSubmitDate': '2016-02-01', 'studyFirstSubmitQcDate': '2016-02-02', 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Balance Berg Scale', 'timeFrame': 'up to 1-month follow-up'}]}, 'conditionsModule': {'conditions': ['Stroke, Postural Balance, Virtual Rehabilitation']}, 'descriptionModule': {'briefSummary': 'The level of stroke chronicity has been proposed as an influential variable related to functional balance. However, little is known about the effect of this variable on the effectiveness and maintenance of gains of physical therapy interventions on balance. The objective of this study is to determine the influence of time since injury on the rehabilitation of balance after stroke. Participants will be assigned to a least (6-12 months), a moderate (12-24 months), or a most chronic (\\> 24 months) group. All the participants will train for 20 one-hour sessions, administered three to five times a week, combining conventional physical therapy exercises and customized exercises interfaced on a balance board that promotes the training of the ankle and hip strategies. Participants will be assessed before, after the intervention, and one month later with a posturography test (sway speed and limits of stability) and clinical scales (Berg Balance Scale, Functional Reaches Test, 30-Second Sit-to-Stand Test, Timed Up and Down Stairs Test, Stepping Test, Timed Up-and-Go Test, and the 10-meter Walking Test).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 50 and ≤ 65 years old\n* Chronicity \\> six months\n* Fairly good cognitive condition defined by scores in the Mini-Mental State Examination above 23\n* Ability to walk 10 meters indoors with or without technical orthopaedic aids.\n\nExclusion Criteria:\n\n* Impaired comprehension that hinder sufficient understanding of the instructions defined by Mississippi Aphasia Screening Test scores below 45\n* Unilateral spatial neglect\n* Ataxia or any other cerebellar symptom\n* Severe auditory or visual impairments\n* Motional or behavioural circumstances that impede adequate collaboration.'}, 'identificationModule': {'nctId': 'NCT02673294', 'briefTitle': 'Chronicity Dependence of a Balance Training in Adults Post-stroke', 'organization': {'class': 'OTHER', 'fullName': 'Hospitales Nisa'}, 'officialTitle': 'Chronicity Dependence of a Balance Training in Adults Post-stroke', 'orgStudyIdInfo': {'id': 'HNISA2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention (6-12 months)', 'description': 'Participants with a chronicity between 6-12 months', 'interventionNames': ['Other: balance virtual rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention (12-24 months)', 'description': 'Participants with a chronicity between 12-24 months', 'interventionNames': ['Other: balance virtual rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention (>24 months)', 'description': 'Participants with a chronicity \\>24 months', 'interventionNames': ['Other: balance virtual rehabilitation']}], 'interventions': [{'name': 'balance virtual rehabilitation', 'type': 'OTHER', 'armGroupLabels': ['Intervention (12-24 months)', 'Intervention (>24 months)', 'intervention (6-12 months)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospitales Nisa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitat Politècnica de València', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}