Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00385918
Status:
COMPLETED
Last Update Posted:
2014-05-14
First Post:
2006-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010264', 'term': 'Paraplegia'}, {'id': 'D011782', 'term': 'Quadriplegia'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pgorman@umm.edu', 'phone': '410-448-6261', 'title': 'Peter H. Gorman, MD Chief Division of Rehabilitation Medicine', 'organization': 'University of Maryland Rehabiitation and Orthopaedic Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '1. Skin irritation caused missed sessions.\n2. Attendance rates were lower than desired given medical and transportation factors.\n3. No clearly defined exclusion criteria for bone density in individuals with SCI using this type intervention.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lokomat Training', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.\n\nLokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.', 'otherNumAtRisk': 15, 'otherNumAffected': 5, 'seriousNumAtRisk': 15, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Home Stretching Then Lokomat Training', 'description': 'Patients will participate in a home stretching program for 3 months.\n\nHome stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.This group will switch to the 3-month robotic intervention after completing the home-based training program.', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin abrasion', 'notes': 'Participants experienced skin abrasions in several areas due to the parachute harness. The following areas were affected: scrotum, scapulae, leg, axilla, chest, shoulder, and groin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection (UTI)', 'notes': 'One participant experienced several urinary tract infections during the course of the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruise', 'notes': 'The participant experienced a bruise to the sternum and groin regions on 2 separate visits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General pain and lethargy', 'notes': 'Several participants experienced general skeletal muscle, back and knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood in urine', 'notes': "The participant observed blood in his urine. The participant was referred to his urologist for evaluation. This incident did not affect the participant's involvement in the training intervention.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotensive response', 'notes': 'The participant began to experience dizziness and light-headed symptoms prior to a training intervention. A low blood pressure response may have been factor for this event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Significant Weight Loss', 'notes': 'The participant reported a 20 pound with loss during a 3-4 month time frame. The participant was instructed to schedule an appointment with his primary care physician for a complete evaluation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle Swelling', 'notes': 'The participant reported ankle swelling following a 45-minute robotic training session. The research medical staff evaluated the problem and cleared the participant to continue training with minimal limitations to the exercise intensity and duration.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Chest and Abdominal Pain', 'notes': 'EKG was not consistent with cardiac ischemia. The subject was excluded from further exercise until he was able to undergo a thallium stress test, which did not reveal any ischemic cardiovascular disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lokomat Training', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.\n\nLokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.'}, {'id': 'OG001', 'title': 'Home Stretching Then Lokomat Training', 'description': 'Patients will participate in a home stretching program for 3 months.\n\nHome stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.\n\nThe stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.'}], 'classes': [{'title': 'Pre (time frame 0) VO2 peak', 'categories': [{'measurements': [{'value': '20.2', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Midpoint (1.5 months) VO2 peak', 'categories': [{'measurements': [{'value': '22.5', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Post_VO2 peak (3 months)', 'categories': [{'measurements': [{'value': '22.7', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch group at 3 months pre Lokomat (n=6)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch group VO2 peak midpoint (4.5 months)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '19.3', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch group VO2 peak post (6 months)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '7.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 1.5 and 3, 4.5, and 6 months', 'description': 'Peak V02 measurements taken during Lokomat exercise in order to measure cardiovascular fitness.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.', 'unitOfMeasure': 'ml/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A single outlier point in the baseline data in one control subject was noted. Laboratory journal notes for this subject indicated that this individual had far more episodes of robotic treadmill stops during his baseline testing due to a high degree of spasticity. Given this, we felt justified in excluding this outlier from further data analysis.'}, {'type': 'SECONDARY', 'title': 'Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lokomat Training', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.\n\nLokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.'}, {'id': 'OG001', 'title': 'Home Stretching Then Lokomat Training', 'description': 'Patients will participate in a home stretching program for 3 months.\n\nHome stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.\n\nThe stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.'}], 'classes': [{'title': 'Body Mass_Baseline', 'categories': [{'measurements': [{'value': '80.8', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '94.3', 'spread': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Body Mass_Post (3 months)', 'categories': [{'measurements': [{'value': '79.8', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '92.3', 'spread': '23.3', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch group pre (3 months) Body mass', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '93.4', 'spread': '22.8', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch group post Body mass (6 months)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '94.8', 'spread': '22.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline (Time point 0), 3, and 6 months', 'description': 'DXA assessment of total body mass.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Body Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lokomat Training', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.\n\nLokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.'}, {'id': 'OG001', 'title': 'Home Stretching Then Lokomat Training', 'description': 'Patients will participate in a home stretching program for 3 months.\n\nHome stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.\n\nThe stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.'}], 'classes': [{'title': 'Percent Body Fat_Baseline (time 0)', 'categories': [{'measurements': [{'value': '33.6', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '34.2', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Percent Body Fat_Post (3 months)', 'categories': [{'measurements': [{'value': '32.4', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch group pre %Body fat (3 months)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch group post %Body fat (6 months)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '33.7', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline (Time point 0), 3, and 6 months', 'description': 'An assessment of percent body fat as determined by DXA analysis.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.', 'unitOfMeasure': 'percent of total mass', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lokomat Treatment', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.\n\nLokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.'}, {'id': 'OG001', 'title': 'Home Stretching Then Lokomat Training', 'description': 'Patients will participate in a home stretching program for 3 months.\n\nHome stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.\n\nThe stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.'}], 'classes': [{'title': 'Pre (time frame 0) VO2 peak arm ergometry', 'categories': [{'measurements': [{'value': '20.0', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Midpoint (1.5 months) VO2 peak arm ergometry', 'categories': [{'measurements': [{'value': '19.8', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Post (3 months) VO2 peak arm ergometry', 'categories': [{'measurements': [{'value': '21.7', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch group (3 months) pre Lokomat training', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch group midpoint (4.5 m) Lokomat', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch group post Lokomat (6 mod)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'treatment completed', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 1.5 and 3, 4.5, and 6 months', 'description': 'Peak oxygen consumption during arm cycle ergometry as a measure of cardiovascular fitness.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.', 'unitOfMeasure': 'ml/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lean Muscle Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lokomat Training', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.\n\nLokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.'}, {'id': 'OG001', 'title': 'Home Stretching Then Lokomat Training', 'description': 'Patients will participate in a home stretching program for 3 months.\n\nHome stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.\n\nThe stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.'}], 'classes': [{'title': 'Lean Muscle Mass_Baseline (0 months)', 'categories': [{'measurements': [{'value': '51.2', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '58.9', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Lean Muscle Mass_Post (3 months)', 'categories': [{'measurements': [{'value': '51.4', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '58.3', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch Group Pre Lean Muscle Mass (3 months)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '59.0', 'spread': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'Home muscle Group Post Lean Muscle Mass (6 months)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '59.9', 'spread': '10.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline (Time point 0) and 3 months', 'description': 'DXA measurement of total lean muscle mass.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Mineral Content', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lokomat Training', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.\n\nLokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.'}, {'id': 'OG001', 'title': 'Home Stretching Then Lokomat Training', 'description': 'Patients will participate in a home stretching program for 3 months.\n\nHome stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.\n\nThe stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.'}], 'classes': [{'title': 'Bone Mineral Content_Baseline (0 months)', 'categories': [{'measurements': [{'value': '3.04', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '3.18', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Bone Mineral Content_Post (3 months)', 'categories': [{'measurements': [{'value': '3.02', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch Pre Bone Mineral Content (3 months)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '3.17', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Home stretch Post Bone Mineral Content (6 months)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Treatment completed', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '0.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline (Time point 0), 3, and 6 months', 'description': 'DXA assessment of bone mineral content.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Six Minute Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lokomat Training', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.\n\nLokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.'}, {'id': 'OG001', 'title': 'Home Stretching Then Lokomat Training', 'description': 'Patients will participate in a home stretching program for 3 months.\n\nHome stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.\n\nThe stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.'}], 'classes': [{'title': 'Six-minute Walk_Baseline (0 months)', 'categories': [{'measurements': [{'value': '179.5', 'spread': '76.4', 'groupId': 'OG000'}, {'value': '203.0', 'spread': '108.3', 'groupId': 'OG001'}]}]}, {'title': 'Six-minute Walk_Post (3 months)', 'categories': [{'measurements': [{'value': '201.6', 'spread': '94.6', 'groupId': 'OG000'}, {'value': '250.8', 'spread': '136.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured Baseline (Time point 0) and 3 months', 'description': 'A functional capacity test to evaluate walking distance during a 6-minute time frame.\n\nThis measure was only done on those participants that were able to walk for 6 minutes, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 randomized to the home stretching group.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '10-meter Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lokomat Training', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.\n\nLokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.'}, {'id': 'OG001', 'title': 'Home Stretching Then Lokomat Training', 'description': 'Patients will participate in a home stretching program for 3 months.\n\nHome stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.\n\nThe stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.'}], 'classes': [{'title': '10-meter walk_Baseline (0 months)', 'categories': [{'measurements': [{'value': '23.0', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': '10-meter walk_post (3 months)', 'categories': [{'measurements': [{'value': '21.3', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '7.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline (Time point 0) and 3 months', 'description': 'A functional capacity test to measure speed.\n\nThis measure was only done on those participants that were able to walk, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 who were randomized to home stretching.\n\nNote that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Step Activity Monitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lokomat Training', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.\n\nLokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.'}, {'id': 'OG001', 'title': 'Home Stretching Then Lokomat Training', 'description': 'Patients will participate in a home stretching program for 3 months.\n\nHome stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.\n\nThe stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.'}], 'classes': [{'title': 'Average 24-hour step total_Baseline (0 months)', 'categories': [{'measurements': [{'value': '1674.8', 'spread': '1129.1', 'groupId': 'OG000'}, {'value': '1531.3', 'spread': '1576.2', 'groupId': 'OG001'}]}]}, {'title': 'Average 24-hour step total_Post (3 months)', 'categories': [{'measurements': [{'value': '1579.9', 'spread': '1078.4', 'groupId': 'OG000'}, {'value': '1652.4', 'spread': '1707.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline (Time point 0) and 3 months', 'description': 'The step activity monitor measures the total steps taken by an individual over a 48 hour time frame in the home environment.\n\nThis measure was only done on those participants that were able to walk in the community and did not use a wheelchair for community mobility, which represented 7 in the Lokomat training group out of the 12 total randomized to Lokomat training and 5 out of 6 of the people randomized to home stretching.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.', 'unitOfMeasure': 'steps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lokomat Training', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.\n\nLokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.'}, {'id': 'FG001', 'title': 'Home Stretching Then Lokomat Training', 'description': 'Patients will participate in a home stretching program for 3 months.\n\nHome stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.\n\nAfter 3 months the participants will be switched to a 3 month period of Lokomat training the same as that offered to the patients randomized to the "Lokomat Training" arm of the study.'}, {'id': 'FG002', 'title': 'Baseline and Feasibility Testing', 'description': 'All subjects were screened and underwent baseline testing prior to randomization into either the Lokomat training or the Home stretching then Lokomat training group.'}], 'periods': [{'title': 'Feasibility & Baseline Measurement Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Total # of subjects screened.The screening occurred before randomization.', 'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'Number Eligible', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '8 subjects failed screening.', 'groupId': 'FG002', 'numSubjects': '27'}]}, {'type': 'Completed Baseline Tests', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '6 subjects did not complete all baseline tests.', 'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'outside of inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Intervention Phase After Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participant successfully completed screening; this is the number in the Lokomat training arm.', 'groupId': 'FG000', 'numSubjects': '15'}, {'comment': 'Participants successfully completed screening; this is the number in the home stretching arm.', 'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants completed the 3-month training intervention', 'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'Participants completed the 3-month home-base intervention', 'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Dates of recruitment: April 2007 through 2010. Location of recruitment: Kernan Hospital Spinal Cord Injury Clinic and Baltimore VAMC Spinal Cord Support Clinic.', 'preAssignmentDetails': 'Participants all underwent baseline and feasibility testing prior to randomization in either of the two arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lokomat Exercise', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.\n\nLokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.'}, {'id': 'BG001', 'title': 'Home Stretching Then Lokomat Exercise', 'description': 'Patients will participate in a home stretching program for 3 months. They will then be crossed over to Lokomat treatment for an additional 3 months.\n\nHome stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '52.0', 'spread': '15.4', 'groupId': 'BG001'}, {'value': '51.7', 'spread': '13.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lower Extremity Motor Score', 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '36.2', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '34.8', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The motor score assigned to the five key bi-lateral lower extremity muscle groups with values ranging from 0 (total paralysis) to 5 (normal) function for each muscle. Because 10 muscles are being tested (5 in each leg), the total possible motor score is 50.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass', 'classes': [{'categories': [{'measurements': [{'value': '80.8', 'spread': '14.6', 'groupId': 'BG000'}, {'value': '94.3', 'spread': '25.0', 'groupId': 'BG001'}, {'value': '85.3', 'spread': '19.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass was determined from a DXA (dual energy x-ray absorptiometry) assessment prior to the 3-month intervention.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASIA Impairment Scale', 'classes': [{'title': 'ASIA impairment C', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'ASIA impairment D', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'American Spinal Injury Association (ASIA) Impairment Scale is used to grade the degree of sensory \\& motor impairment.\n\nASIA impairment scale C- motor function preserved below the neurological level with \\> half of the key muscles below the neurological level displaying a grade of less than 3 on a 5-pt scale.\n\nASIA impairment scale D- motor function is preserved below the neurological level with at least half of the key muscles below the neurological level displaying a grade of 3 or more on the 5-pt scale.\n\nfor neurological level see: http://asia-spinalinjury.org/elearning/ASIA\\_ISCOS\\_high.pdf', 'unitOfMeasure': 'participants'}, {'title': 'Impairment Function', 'classes': [{'title': 'Tetraplegia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Paraplegia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Tetraplegia- refers to impairment or loss of function in the cervical region with an effect to the upper and lower extremity\n\nParaplegia- impairment or loss of function to the thoracic, lumbar, or sacral regions with an effect to the lower extremity', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The baseline analysis includes data from individuals who have completed the 3-month robotic and home-base interventions'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-11', 'studyFirstSubmitDate': '2006-10-06', 'resultsFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2006-10-10', 'lastUpdatePostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-11', 'studyFirstPostDateStruct': {'date': '2006-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments', 'timeFrame': '0, 1.5 and 3, 4.5, and 6 months', 'description': 'Peak V02 measurements taken during Lokomat exercise in order to measure cardiovascular fitness.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.'}, {'measure': 'Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments.', 'timeFrame': '0, 1.5 and 3, 4.5, and 6 months', 'description': 'Peak oxygen consumption during arm cycle ergometry as a measure of cardiovascular fitness.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.'}], 'secondaryOutcomes': [{'measure': 'Body Mass', 'timeFrame': 'Measured at Baseline (Time point 0), 3, and 6 months', 'description': 'DXA assessment of total body mass.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.'}, {'measure': 'Percent Body Fat', 'timeFrame': 'Measured at Baseline (Time point 0), 3, and 6 months', 'description': 'An assessment of percent body fat as determined by DXA analysis.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.'}, {'measure': 'Lean Muscle Mass', 'timeFrame': 'Measured at Baseline (Time point 0) and 3 months', 'description': 'DXA measurement of total lean muscle mass.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.'}, {'measure': 'Bone Mineral Content', 'timeFrame': 'Measured at Baseline (Time point 0), 3, and 6 months', 'description': 'DXA assessment of bone mineral content.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.'}, {'measure': 'Six Minute Walk', 'timeFrame': 'Measured Baseline (Time point 0) and 3 months', 'description': 'A functional capacity test to evaluate walking distance during a 6-minute time frame.\n\nThis measure was only done on those participants that were able to walk for 6 minutes, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 randomized to the home stretching group.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.'}, {'measure': '10-meter Walk', 'timeFrame': 'Measured at Baseline (Time point 0) and 3 months', 'description': 'A functional capacity test to measure speed.\n\nThis measure was only done on those participants that were able to walk, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 who were randomized to home stretching.\n\nNote that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.'}, {'measure': 'Step Activity Monitor', 'timeFrame': 'Measured at Baseline (Time point 0) and 3 months', 'description': 'The step activity monitor measures the total steps taken by an individual over a 48 hour time frame in the home environment.\n\nThis measure was only done on those participants that were able to walk in the community and did not use a wheelchair for community mobility, which represented 7 in the Lokomat training group out of the 12 total randomized to Lokomat training and 5 out of 6 of the people randomized to home stretching.\n\nPlease note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiovascular Fitness', 'Exercise', 'Gait', 'Spinal Cord Injury', 'Treadmill Training'], 'conditions': ['Paraplegia', 'Quadriplegia', 'Spinal Cord Injury', 'Tetraplegia']}, 'referencesModule': {'references': [{'pmid': '24534779', 'type': 'RESULT', 'citation': 'Gorman PH, Geigle PR, Chen K, York H, Scott W. Reliability and relatedness of peak VO2 assessments during body weight supported treadmill training and arm cycle ergometry in individuals with chronic motor incomplete spinal cord injury. Spinal Cord. 2014 Apr;52(4):287-91. doi: 10.1038/sc.2014.6. Epub 2014 Feb 18.'}, {'pmid': '25520035', 'type': 'DERIVED', 'citation': 'Gorman PH, Scott W, York H, Theyagaraj M, Price-Miller N, McQuaid J, Eyvazzadeh M, Ivey FM, Macko RF. Robotically assisted treadmill exercise training for improving peak fitness in chronic motor incomplete spinal cord injury: A randomized controlled trial. J Spinal Cord Med. 2016;39(1):32-44. doi: 10.1179/2045772314Y.0000000281. Epub 2014 Dec 18.'}], 'seeAlsoLinks': [{'url': 'http://www.hocoma.com', 'label': 'Website of the manufacturer of the Lokomat'}, {'url': 'http://www.kernan.org', 'label': 'Hospital where the research is being undertaken.'}]}, 'descriptionModule': {'briefSummary': 'This proposal investigates the hypothesis that progressive aerobic exercise with Lokomat is feasible in people with motor incomplete spinal cord injury, and three months of training will improve cardiovascular fitness and gait functionality when compared to physical therapy controls', 'detailedDescription': 'Little information is available about the cardiovascular effects of robotically assisted partial weight support treadmill training devices such as Lokomat in chronic incomplete spinal cord injured subjects. Task-oriented aerobic exercise has the potential to improve both neuromuscular function and cardiovascular metabolic fitness in neurological populations. Since spinal cord injured individuals are at an increased risk of developing premature cardiovascular disease, the investigation of robotic-assisted interventions in spinal cord injury (SCI) such as the Lokomat may have important health benefits in both cardiovascular fitness as well as functional mobility.\n\nThis proposal investigates the hypothesis that progressive aerobic exercise with Lokomat is feasible in motor incomplete SCI, and three months of training will improve cardiovascular fitness and gait functionality when compared to physical therapy controls. We propose a two-phase study to examine the feasibility, reliability and utility of aerobic exercise metabolic testing and training during robotically assisted partial weight support treadmill walking in individuals with chronic motor incomplete spinal cord injury (CMISCI). During the first phase of the study we will manipulate Lokomat training parameters of treadmill speed and percent of partial weight support to assess the effect of these changes on heart rate, perceived exertion, and oxygen consumption in untrained chronic motor incomplete spinal cord injured subjects. Subjects will be asked to maintain cardiovascular or muscular effort during testing and will be monitored in this regard by the force biofeedback system built into the Lokomat. After determining threshold levels for initial cardiovascular response, submaximal and then peak exercise testing will be attempted. These studies will be repeated on a separate day to determine the reliability of the testing results. Thirty-six subjects with varying levels of injury between C4 and L2 and ASIA (American Spinal Injury) Impairment Scales of C and D will be recruited. We anticipate that subjects with greater ASIA motor scores will require either a faster initial treadmill speed or less partial weight support to produce an initial cardiovascular response. It is also anticipated that peak exercise testing using open circuit spirometry with subjects on the Lokomat will be a feasible, reliable and valid measurement. This phase of the study will be aimed at establishing guidelines for determining initial training parameters for use in an aerobic exercise protocol using the Lokomat.\n\nThe second phase of this pilot study will be a controlled trial of three-month progressive aerobic Lokomat exercise in chronic incomplete spinal cord injured subjects. The aim of this trial will be to determine whether progressive Lokomat training will improve cardiovascular fitness and ambulatory function when compared to matched impairment severity CMISCI subjects receiving the same duration of usual physical therapy care. Thirty-six subjects will be recruited into this phase of the study. Open spirometric evaluation of cardiovascular parameters as outlined in phase one of the proposal will be measured at baseline, 1 months, and 3 months. Initial, six-week and post-study ambulatory function evaluations including the WISCI (Walking Index for Spinal Cord Injury), a timed 10 meter walk, a measured walk over 6 minutes, and a gait analysis will also be determined. It is hypothesized that aerobic Lokomat exercise will improve cardiovascular fitness as determined by an increase in VO2 (oxygen consumption) peak and improve function as determined by timed walks and gait parameters in these subjects. The results of this pilot and development study will provide the necessary information to design larger randomized clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute onset Spinal Cord Injury or Disease at least 12 months prior to enrollment\n* Age 18 to 80\n* Level of injury from C4 to L2\n* ASIA impairment scale either C or D\n* Able to tolerate standing frame for at least 30 minutes\n\nExclusion Criteria:\n\n* History of unstable angina, recent MI (myocardial infarction), CHF (congestive heart failure) or clinically significant valvular dysfunction\n* History of recent hospitalization (\\<3 months) for a major medical problem'}, 'identificationModule': {'nctId': 'NCT00385918', 'briefTitle': 'Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Cardiovascular Parameters for Lokomat Training in Chronic Incomplete SCI', 'orgStudyIdInfo': {'id': 'B4027'}, 'secondaryIdInfos': [{'id': 'B40271', 'type': 'OTHER', 'domain': 'UMB-IRB old BRAAN system'}, {'id': 'HP-00042597', 'type': 'OTHER', 'domain': 'UMB-IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lokomat training', 'description': 'Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.', 'interventionNames': ['Device: Lokomat Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Home stretching then Lokomat training', 'description': 'Patients will participate in a home stretching program for 3 months. They will then be crossed over to an active Lokomat treatment for a subsequent 3 months.', 'interventionNames': ['Other: Home stretching then Lokomat training']}], 'interventions': [{'name': 'Lokomat Training', 'type': 'DEVICE', 'description': 'The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.', 'armGroupLabels': ['Lokomat training']}, {'name': 'Home stretching then Lokomat training', 'type': 'OTHER', 'description': 'Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. After 3 months the patients will be crossed over to Lokomat training for an additional 3 months. This training will be the same as given to the individuals originally randomized to the Lokomat treatment intervention.', 'armGroupLabels': ['Home stretching then Lokomat training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'VA Maryland Health Care System, Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21207', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Rehabilitation and Orthopaedic Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Peter Gorman, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Maryland Health Care System, Baltimore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'collaborators': [{'name': 'University of Maryland', 'class': 'OTHER'}, {'name': 'Kernan Orthopaedics and Rehabilitation Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}