Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-11 @ 7:42 PM
Study NCT ID:
NCT00629005
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
2008-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strength Training and 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': 'D000098483', 'term': 'Constraint Induced Movement Therapy'}, {'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D016059', 'term': 'Range of Motion, Articular'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-28', 'studyFirstSubmitDate': '2008-02-19', 'studyFirstSubmitQcDate': '2008-02-26', 'lastUpdatePostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Motor Assessment - UE Subscale', 'timeFrame': 'Immediately after the end of therapy and 6 months later'}], 'secondaryOutcomes': [{'measure': 'Wolf Motor Function Test', 'timeFrame': 'Immediately after the end of therapy and 6 months later'}, {'measure': 'Cortical mapping using transcranial magnetic stimulation', 'timeFrame': 'Immediately after the end of therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rehabilitation', 'upper extremity', 'motor skills'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'People with stroke experience weakness and incoordination. Studies have shown that with functional task practice, people can increase motor control and strength to a certain extent. This study will investigate whether adding progressive resistance strength training to functional task practice modeled after Constraint-Induced Movement Therapy results in greater motor function gains than functional task practice alone', 'detailedDescription': 'To date most investigations of UE rehabilitation have examined single interventions. However, combining 2 efficacious interventions may enhance effectiveness. Both functional task training and strength training are beneficial for promoting improved upper extremity function, but they have seldom been studied as a coupled therapy. The research proposed in this project will examine the effect on UE function of adding UE resistive exercises to functional task training. Secondary aims are to examine the effect of stroke severity on the response to therapy, the interrelationship between therapy-induced neural changes and movement composition and functional changes with therapy, and test for retention of UE function gains over 6 months. Individuals with chronic hemiparesis from stroke will complete baseline testing and then be randomly assigned to either the functional task + strength training group or the functional task training alone group. Each group will train 4 hours/day, 3 days/week for 4 weeks. Each will perform 3 hours of functional task training per session. The strengthening group will then complete 1 hour of UE progressive resistance exercises while the functional task training alone group will complete gravity eliminated range of motion exercises for 1 hour. All subjects will be post-tested and then complete follow-up testing 6 months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. age 40-85;\n2. a single unilateral middle cerebral artery ischemic stroke;\n3. no history of drug/alcohol abuse;\n4. ability to follow 3-step commands and provide informed consent;\n5. no history of other neural disorder/dysfunction (including epilepsy), no serious medical illness or refractory depression;\n6. at least 300 active upper extremity elevation in scapular plane (combination of flexion and abduction);\n7. ability to extend the wrist 20 degrees, and two fingers and thumb 10 degrees three times in a minute;\n8. permission of physician (BRRC medical director or BRRC neurologist) to participate in strength training.\n\nExclusion Criteria:\n\n1. spasticity in elbow or hand (Modified Ashworth Scale \\> 2);\n2. Motor Activity Log32 scores \\>3 (which would indicate relatively good use of the upper extremity);\n3. ability to complete 135 degrees shoulder elevation easily with elbow straight (e.g., doesn't hold breath, movement is fluid, little to no effort tremor observed);\n4. ataxia, major sensory deficits, or hemi-inattention/neglect;"}, 'identificationModule': {'nctId': 'NCT00629005', 'briefTitle': 'Strength Training and Stroke', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Should We Train Strength or Skill in Post-Stroke Rehabilitation?', 'orgStudyIdInfo': {'id': 'B5033-W'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Constraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus 1 hour of strength training for the arms and hands 3x/week', 'interventionNames': ['Behavioral: Constraint-Induced Movement Therapy + strength training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Constraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus non-resisted arm and hand movements for 1 hour 3x/week', 'interventionNames': ['Behavioral: Constraint-Induced Movement Therapy + range of motion']}], 'interventions': [{'name': 'Constraint-Induced Movement Therapy + strength training', 'type': 'BEHAVIORAL', 'otherNames': ['forced use, functional task practice, progressive resistive exercise'], 'description': 'Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of resistance elastic band exercises', 'armGroupLabels': ['Arm 1']}, {'name': 'Constraint-Induced Movement Therapy + range of motion', 'type': 'BEHAVIORAL', 'otherNames': ['forced use, functional task practice'], 'description': 'Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of unresisted arm movements for', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'North Florida/South Georgia Veterans Health System', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Stephen E. Nadeau, MD BS BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Florida/South Georgia Veterans Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}