Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT04050150
Status:
COMPLETED
Last Update Posted:
2022-01-12
First Post:
2019-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arm Training in Standing After 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078783', 'term': 'Standing Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-10', 'studyFirstSubmitDate': '2019-08-06', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': 'Change from Baseline to 8 weeks', 'description': 'Clinical measure of balance. 14-item performance measure with a maximum score of 56; higher score is better.'}, {'measure': 'Functional Gait Assessment', 'timeFrame': 'Change from Baseline to 8 weeks', 'description': 'Clinical measure of balance'}, {'measure': 'Stroke Impact Scale Mobility Subscale', 'timeFrame': 'Change from Baseline to 8 weeks', 'description': 'Patient-reported measure of mobility related quality-of-life. Score ranges from 0 to 100 with higher being better'}, {'measure': 'Action Research Arm Test', 'timeFrame': 'Change from Baseline to 12 weeks', 'description': 'Clinical measure of arm and hand function'}, {'measure': 'Arm Use Measured with Accelerometers', 'timeFrame': 'Change from Baseline to 12 weeks', 'description': 'Arm use measured during a typical day using accelerometers worn on the wrist'}], 'primaryOutcomes': [{'measure': 'Sessions Completed', 'timeFrame': '8 weeks', 'description': 'Total number of treatment sessions completed'}, {'measure': 'Fatigue', 'timeFrame': '8 weeks', 'description': 'Mean change in self-reported fatigue from the start to the end of each intervention session'}, {'measure': 'Treatment intensity', 'timeFrame': '8 weeks', 'description': 'Total number of arm repetitions per session and the percent of arm repetitions completed in standing or walking'}, {'measure': 'Action Research Arm Test', 'timeFrame': 'Change from Baseline to 8 weeks', 'description': 'Clinical measure of arm and hand function'}, {'measure': 'Arm Use Measured with Accelerometers', 'timeFrame': 'Change from Baseline to 8 weeks', 'description': 'Arm use measured during a typical day using accelerometers worn on the wrist'}], 'secondaryOutcomes': [{'measure': 'Upper Extremity Fugl-Meyer', 'timeFrame': 'Change from Baseline to 8 weeks', 'description': 'Clinical Measure of arm and hand impairment'}, {'measure': 'Box & Blocks Test', 'timeFrame': 'Change from Baseline to 8 weeks', 'description': 'Clinical measure of hand function'}, {'measure': 'Nine-Hole Peg Test', 'timeFrame': 'Change from Baseline to 8 weeks', 'description': 'Clinical measure of hand dexterity'}, {'measure': 'Stroke Impact Scale Hand Domain Subscale', 'timeFrame': 'Change from Baseline to 8 weeks', 'description': 'Patient-reported measure of hand related quality-of-life. Score ranges from 0 to 100 with higher being better.'}, {'measure': 'Timed Up and Go', 'timeFrame': 'Change from Baseline to 8 weeks', 'description': 'Clinical measure of mobility and balance'}, {'measure': 'Activities Specific Balance Confidence Scale', 'timeFrame': 'Change from Baseline to 8 weeks', 'description': 'Patient-reported measure of balance confidence. Score ranges from 0 to 100 with higher being better'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rehabilitation', 'Upper Extremity'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This study will examine the feasibility of providing task-oriented arm training in standing or during walking in individuals with movement deficits due to stroke. Participants will received 24 sessions of arm training in standing over an 8-week period that focus on arm and hand function.', 'detailedDescription': 'Residual motor deficits are common after stroke and often have a negative impact on the performance of functional activities and overall quality of life. A frequently reported contribution to these functional limitations is an inability to incorporate the weaker arm and hand into daily activities. While rehabilitation interventions can improve arm functional capacity, these improvements often do not translate into increased real-world arm use which is often reduced after stroke.\n\nThe performance of skilled arm and hand movements in standing requires precise coordination between upper extremity movement and balance control. Many everyday functional tasks that require the arm are performed in standing (e.g. opening a door or meal preparation at the kitchen counter), however, training of arm function in rehabilitation is often done in sitting. An important rehabilitation approach may be to create a training environment that resembles the way the arm is used in everyday life (i.e. standing). This study will examine the feasibility of providing task-oriented, functional arm training in standing and during walking in individuals with motor deficits due to stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 18 years old\n* Had a stroke at least 6 months prior to enrollment\n* Show evidence of continued arm and hand weakness\n* Have some ability to move the arm and hand that is weaker from the stroke\n* Be able to stand with minimal assistance or less without support of the weaker arm for at least 2 minutes\n* Be able to follow two-step commands.\n\nExclusion Criteria:\n\n* Acute medical issues that would interfere with participation\n* Another neurologic diagnosis that may impact movement (e.g. Parkinson's Disease)\n* Severe apraxia or hemispatial neglect\n* Pain that interferes with arm movement or standing"}, 'identificationModule': {'nctId': 'NCT04050150', 'briefTitle': 'Arm Training in Standing After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Task-oriented Training of Arm Function in Standing After Stroke: a Pilot Study', 'orgStudyIdInfo': {'id': 'Pro00080332'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm Training in Standing', 'description': 'Task-oriented, functional arm training completed in standing or during walking. All participants receive the same arm training intervention.', 'interventionNames': ['Behavioral: Arm training in standing']}], 'interventions': [{'name': 'Arm training in standing', 'type': 'BEHAVIORAL', 'description': 'Arm training will be provided in one hour sessions, 3 time per week for 8 weeks. In each session, you will practice functional tasks with your weaker arm and hand in standing or during walking. Practice will be scaled to match your current level of function and progressed over time as able.', 'armGroupLabels': ['Arm Training in Standing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Jll Stewart, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'ipdSharingStatementModule': {'timeFrame': '1 year after study completion', 'ipdSharing': 'YES', 'description': 'De-identified data will be made available per reasonable request to the principal investigator 1 year after study completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jill Stewart, PT, PhD', 'investigatorAffiliation': 'University of South Carolina'}}}}