Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-11 @ 2:10 AM
Study NCT ID:
NCT01929018
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2013-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Collaborative-care Rehabilitation After Dysvascular Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cory.christiansen@ucdenver.edu', 'phone': '303.724.9101', 'title': 'Dr. Cory Christiansen', 'organization': 'University of Colorado Denver, Anschutz Medical Campus'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size limited statistical power to identify group differences in secondary outcomes. CTL group exercise behavior only tracked step count. No direct measurement of intervention fidelity.'}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Exercise, Activity, and Self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.\n\nExercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.\n\nWalking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.\n\nHealth Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 14, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Home and Phone Visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 11, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Opiod Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Increased medical management', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Timed Up-and-Go Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise, Activity, and Self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.\n\nExercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.\n\nWalking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.\n\nHealth Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.'}, {'id': 'OG001', 'title': 'Home and Phone Visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '23.9'}, {'value': '20.7', 'groupId': 'OG001', 'lowerLimit': '15.6', 'upperLimit': '25.7'}]}]}, {'title': '12-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '13.4', 'upperLimit': '22.9'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '24.1'}]}]}, {'title': '24-week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '21.3'}, {'value': '21.3', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '26.7'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 12-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 24-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12-weeks, and 24 weeks', 'description': 'Performance-based physical function test able to predict falls for people with lower limb amputation. The TUG test time is taken from rising from a chair, walking 3 meters, turning, walking back and sitting down. Continuous scale; higher time indicates lower physical function, higher likelihood of falls.', 'unitOfMeasure': 'seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.'}, {'type': 'SECONDARY', 'title': 'Two-Minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise, Activity, and Self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.\n\nExercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.\n\nWalking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.\n\nHealth Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.'}, {'id': 'OG001', 'title': 'Home and Phone Visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000', 'lowerLimit': '76.9', 'upperLimit': '96.9'}, {'value': '84.4', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '95.6'}]}]}, {'title': '12-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '77.6', 'upperLimit': '99.3'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '71.3', 'upperLimit': '95.3'}]}]}, {'title': '24-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.8', 'groupId': 'OG000', 'lowerLimit': '89.6', 'upperLimit': '110.0'}, {'value': '84.0', 'groupId': 'OG001', 'lowerLimit': '72.0', 'upperLimit': '96.1'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 12-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 24-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Performance-based physical function test measures total number of meters walked in two minutes on a level walkway.', 'unitOfMeasure': 'meters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.'}, {'type': 'SECONDARY', 'title': 'Five Meter Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise, Activity, and Self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.\n\nExercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.\n\nWalking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.\n\nHealth Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.'}, {'id': 'OG001', 'title': 'Home and Phone Visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.88'}, {'value': '0.76', 'groupId': 'OG001', 'lowerLimit': '0.66', 'upperLimit': '0.87'}]}]}, {'title': '12-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '1.06'}, {'value': '0.83', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '0.94'}]}]}, {'title': '24-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.97', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '1.06'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '0.98'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 12-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 24-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Performance-based physical function test measures the time to walk 5 meters at the participant\'s "normal, everyday pace".', 'unitOfMeasure': 'meters/second', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.'}, {'type': 'SECONDARY', 'title': 'Prosthesis Evaluation Questionnaire - Mobility Section', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise, Activity, and Self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.\n\nExercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.\n\nWalking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.\n\nHealth Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.'}, {'id': 'OG001', 'title': 'Home and Phone Visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '2.8'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '2.8'}]}]}, {'title': '12-Week', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '3.2'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '2.6'}]}]}, {'title': '24-Week', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '3.3'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '3.0'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 12-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 24-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Self-report physical function questionnaire measures capacity to perform a list of specific functional tasks (e.g., walking upstairs, getting in and out of a vehicle. Scores range from being unable or hardly able (0) to having no problems (4). An average score across the 12-item questionnaire was used in the analysis. Lower numbers indicate less difficulty.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.'}, {'type': 'SECONDARY', 'title': 'Houghton Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise, Activity, and Self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.\n\nExercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.\n\nWalking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.\n\nHealth Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.'}, {'id': 'OG001', 'title': 'Home and Phone Visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': '12-Week', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': '24-Week', 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.83', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 12-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 24-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Self-report physical function questionnaire. The outcome is the sum of scores from each item (min 0, max 12). A higher score indicates higher self-report of physical function with the prosthesis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.'}, {'type': 'SECONDARY', 'title': 'Patient-Specific Function Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise, Activity, and Self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.\n\nExercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.\n\nWalking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.\n\nHealth Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.'}, {'id': 'OG001', 'title': 'Home and Phone Visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '5.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '6.9', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 12-week test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 24-week test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Self-report physical function questionnaire. The outcome is the average score for up to five participant-identified activities on a scale from 0-10 (min 0, max 10). Higher score indicates greater ability to perform functional activities.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.'}, {'type': 'SECONDARY', 'title': 'Physical Activity Step Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise, Activity, and Self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.\n\nExercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.\n\nWalking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.\n\nHealth Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.'}, {'id': 'OG001', 'title': 'Home and Phone Visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1305', 'groupId': 'OG000', 'lowerLimit': '726', 'upperLimit': '1883'}, {'value': '1369', 'groupId': 'OG001', 'lowerLimit': '724', 'upperLimit': '2014'}]}]}, {'title': '12-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2439', 'groupId': 'OG000', 'lowerLimit': '1844', 'upperLimit': '3035'}, {'value': '1512', 'groupId': 'OG001', 'lowerLimit': '849', 'upperLimit': '2175'}]}]}, {'title': '24-Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2294', 'groupId': 'OG000', 'lowerLimit': '1716', 'upperLimit': '2873'}, {'value': '1510', 'groupId': 'OG001', 'lowerLimit': '840', 'upperLimit': '2180'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 12-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 24-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Instrumented physical activity measure, average step counts per day', 'unitOfMeasure': 'average steps per day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.'}, {'type': 'SECONDARY', 'title': 'Self-Efficacy in Managing Chronic Disease Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise, Activity, and Self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.\n\nExercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.\n\nWalking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.\n\nHealth Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.'}, {'id': 'OG001', 'title': 'Home and Phone Visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '8.3'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '8.2'}]}]}, {'title': '12-Week', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '8.4'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '8.6'}]}]}, {'title': '24-Week', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '8.7'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '8.2'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 12-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 24-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Scale range is 1-10. The score for the scale is the mean of the six items, using a ten point scale. Higher number indicates higher self-efficacy.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.'}, {'type': 'SECONDARY', 'title': 'World Health Organization Disability Assessment Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise, Activity, and Self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.\n\nExercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.\n\nWalking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.\n\nHealth Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.'}, {'id': 'OG001', 'title': 'Home and Phone Visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000', 'lowerLimit': '22.9', 'upperLimit': '29.6'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '23.7', 'upperLimit': '31.3'}]}]}, {'title': '12-Week', 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000', 'lowerLimit': '20.9', 'upperLimit': '27.6'}, {'value': '25.3', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '29.2'}]}]}, {'title': '24-Week', 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '25.0'}, {'value': '25.3', 'groupId': 'OG001', 'lowerLimit': '21.4', 'upperLimit': '29.1'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 12-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test null hypothesis that there is no difference between groups from baseline to 24-week test.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Scores ranging from 1 (no difficulty) to 5 (extreme difficulty/cannot do). Overall disability was calculated by summing the scores for the 12 items; higher scores indicated greater disability (score range: 12-60).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exercise, Activity, and Self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.\n\nExercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.\n\nWalking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.\n\nHealth Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.'}, {'id': 'FG001', 'title': 'Home and Phone Visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Hospitalization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'No significant study events occurred after participants were enrolled, but before they were assigned to a study group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exercise, Activity, and Self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.\n\nExercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.\n\nWalking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.\n\nHealth Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.'}, {'id': 'BG001', 'title': 'Home and Phone Visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '65', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Site of Rehab, n, Veterans Administration Medical Center', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants treated at Veterans Administration Medical Center', 'unitOfMeasure': 'Participants'}, {'title': 'BMI, kg/m2', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '30', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '31', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time Since Amputation, weeks', 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '20', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '18', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Geriatric Depression Scale, score out of 15', 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '3.2', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scale range is 0-15. Score is total out of possible maximum of 15. A score of 0 to 5 is normal. A score greater than 5 suggests referral for assessment of depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mini Mental Status Exam, score out of 30', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '27.5', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '28.2', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The maximum score is 30 points. Score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Intrinsic Motivation Inventory, score out of 7', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '5.6', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '5.6', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The mean of the 7 items is the summary score for the Intrinsic Motivation - Interest and Enjoyment Subscale (Min possible 1, Max possible 7). Higher number indicates higher interest/enjoyment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Chakrabarty Grade, score out of 100', 'classes': [{'categories': [{'measurements': [{'value': '77.3', 'spread': '16.2', 'groupId': 'BG000'}, {'value': '82.4', 'spread': '15.0', 'groupId': 'BG001'}, {'value': '79.8', 'spread': '15.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The sum of all items is the score (Min possible -104, Max possible 100). Higher score indicates more favorable residual limb health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Comorbidity Index, score out of 20', 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '7.1', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The comorbidity index is a sum of 18 comorbidities (Min possible 0, Max possible 18). Higher score indicates higher comorbidity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-01-05', 'size': 658581, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-10-26T16:50', 'hasProtocol': True}, {'date': '2014-01-05', 'size': 40196, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-10-26T16:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-18', 'studyFirstSubmitDate': '2013-08-19', 'resultsFirstSubmitDate': '2018-05-29', 'studyFirstSubmitQcDate': '2013-08-21', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-18', 'studyFirstPostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up-and-Go Test', 'timeFrame': 'Baseline, 12-weeks, and 24 weeks', 'description': 'Performance-based physical function test able to predict falls for people with lower limb amputation. The TUG test time is taken from rising from a chair, walking 3 meters, turning, walking back and sitting down. Continuous scale; higher time indicates lower physical function, higher likelihood of falls.'}], 'secondaryOutcomes': [{'measure': 'Two-Minute Walk Test', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Performance-based physical function test measures total number of meters walked in two minutes on a level walkway.'}, {'measure': 'Five Meter Walk Test', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Performance-based physical function test measures the time to walk 5 meters at the participant\'s "normal, everyday pace".'}, {'measure': 'Prosthesis Evaluation Questionnaire - Mobility Section', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Self-report physical function questionnaire measures capacity to perform a list of specific functional tasks (e.g., walking upstairs, getting in and out of a vehicle. Scores range from being unable or hardly able (0) to having no problems (4). An average score across the 12-item questionnaire was used in the analysis. Lower numbers indicate less difficulty.'}, {'measure': 'Houghton Scale', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Self-report physical function questionnaire. The outcome is the sum of scores from each item (min 0, max 12). A higher score indicates higher self-report of physical function with the prosthesis.'}, {'measure': 'Patient-Specific Function Scale', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Self-report physical function questionnaire. The outcome is the average score for up to five participant-identified activities on a scale from 0-10 (min 0, max 10). Higher score indicates greater ability to perform functional activities.'}, {'measure': 'Physical Activity Step Counts', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Instrumented physical activity measure, average step counts per day'}, {'measure': 'Self-Efficacy in Managing Chronic Disease Questionnaire', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Scale range is 1-10. The score for the scale is the mean of the six items, using a ten point scale. Higher number indicates higher self-efficacy.'}, {'measure': 'World Health Organization Disability Assessment Scale', 'timeFrame': 'Baseline, 12 weeks, and 24 weeks', 'description': 'Scores ranging from 1 (no difficulty) to 5 (extreme difficulty/cannot do). Overall disability was calculated by summing the scores for the 12 items; higher scores indicated greater disability (score range: 12-60).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amputation', 'Rehabilitation', 'Exercise', 'Movement'], 'conditions': ['Diabetes Complications', 'Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '29746823', 'type': 'DERIVED', 'citation': 'Christiansen CL, Miller MJ, Murray AM, Stephenson RO, Stevens-Lapsley JE, Hiatt WR, Schenkman ML. Behavior-Change Intervention Targeting Physical Function, Walking, and Disability After Dysvascular Amputation: A Randomized Controlled Pilot Trial. Arch Phys Med Rehabil. 2018 Nov;99(11):2160-2167. doi: 10.1016/j.apmr.2018.04.011. Epub 2018 May 7.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to examine the feasibility of using a collaborative-care, home-based rehabilitation program to improve functional outcomes for people recovering from lower limb amputation caused by vascular problems and/or diabetes complications. The primary hypothesis is that the rehabilitation program will result in greater improvements in performance-based and participant-reported measures of physical function, compared to standard of care after outpatient rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diabetes and/or Peripheral Artery Disease\n2. Unilateral transtibial amputation \\< 6 months prior to screening\n3. Household ambulation using definitive prosthesis prior to baseline testing\n4. Participation in physical rehabilitation at time of baseline testing\n5. Live within 45 minutes of a participating clinic\n\nExclusion Criteria:\n\n1. Require wheelchair for mobility (use prosthesis for transfers only)\n2. Ankle-level or above amputation on contralateral limb\n3. Traumatic or cancer-related amputation\n4. Uncontrolled heart condition\n5. Acute systemic infection\n6. Pregnancy\n7. Decisionally challenged\n8. Prisoners'}, 'identificationModule': {'nctId': 'NCT01929018', 'briefTitle': 'Collaborative-care Rehabilitation After Dysvascular Amputation', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation', 'orgStudyIdInfo': {'id': '13-0179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise, activity, and self-management', 'description': 'Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Walking Program', 'Behavioral: Health Self-Management Support']}, {'type': 'NO_INTERVENTION', 'label': 'Home and phone visit', 'description': 'No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.', 'armGroupLabels': ['Exercise, activity, and self-management']}, {'name': 'Walking Program', 'type': 'BEHAVIORAL', 'description': 'A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.', 'armGroupLabels': ['Exercise, activity, and self-management']}, {'name': 'Health Self-Management Support', 'type': 'BEHAVIORAL', 'description': 'Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.', 'armGroupLabels': ['Exercise, activity, and self-management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Cory L Christiansen, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}