Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT01087918
Status:
COMPLETED
Last Update Posted:
2012-10-29
First Post:
2010-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hubertus.vanhedel@kispi.uzh.ch', 'phone': '+41 44 762 52 91', 'title': 'Hubertus van Hedel, PhD', 'organization': 'UZurich'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Issues to find participants led to small numbers of subjects analyzed. Ambulatory activity besides our interventions was not controlled for.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Robot-assisted Gait Training First, Then Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Strength Training First, Then Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '10 Meter Walking at Preferred Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}, {'id': 'OG001', 'title': 'Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': "The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed \\[m/s\\]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.", 'unitOfMeasure': 'meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Walking Index for Spinal Cord Injury II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}, {'id': 'OG001', 'title': 'Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Berg Balance Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week'}, {'id': 'OG001', 'title': 'Strength Training', 'description': '16 sessions of 45 minutes of strength training 4 times a week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '1.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Spinal Cord Independence Measure III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}, {'id': 'OG001', 'title': 'Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '1.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}, {'id': 'OG001', 'title': 'Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '1.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Manual Muscle Test of the Lower Extremity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}, {'id': 'OG001', 'title': 'Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain on a Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}, {'id': 'OG001', 'title': 'Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 8 patients participated at pain assessments as 1 patient did not suffer from pain.'}, {'type': 'SECONDARY', 'title': 'Response Time of the Lower Extremities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}, {'id': 'OG001', 'title': 'Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '63.0', 'groupId': 'OG000'}, {'value': '-17.6', 'spread': '66.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Falls Efficacy Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}, {'id': 'OG001', 'title': 'Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'spread': '4.99', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '2.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '10 Meter Walking at Maximal Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First RAGT, Then Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}, {'id': 'OG001', 'title': 'First Strength Training, Then RAGT', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed \\[m/s\\]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.', 'unitOfMeasure': 'meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Figure of Eight Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}, {'id': 'OG001', 'title': 'Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.004', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to \\[m/s\\]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.', 'unitOfMeasure': 'meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Robot-assisted Gait Training First, Then Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.'}, {'id': 'FG001', 'title': 'Strength Training First, Then Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participant recruitment from a spinal cord injury hospital in Zurich, Switzerland between March 2009 and March 2011.', 'preAssignmentDetails': '97 possible participants recruited; 9 participated, 88 excluded (12 did not meet inclusion criteria and 76 refused participation)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Robot-assisted Gait Training First, Then Strength Training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.'}, {'id': 'BG001', 'title': 'Strength Training First, Then Robot-assisted Gait Training', 'description': '16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.8', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '59.0', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '80.8', 'spread': '15.9', 'groupId': 'BG000'}, {'value': '70.0', 'spread': '17.1', 'groupId': 'BG001'}, {'value': '76.0', 'spread': '16.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.76', 'spread': '0.077', 'groupId': 'BG000'}, {'value': '1.67', 'spread': '0.075', 'groupId': 'BG001'}, {'value': '1.72', 'spread': '0.086', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-22', 'studyFirstSubmitDate': '2010-03-15', 'resultsFirstSubmitDate': '2012-05-10', 'studyFirstSubmitQcDate': '2010-03-15', 'lastUpdatePostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-18', 'studyFirstPostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10 Meter Walking at Preferred Speed', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': "The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed \\[m/s\\]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements."}, {'measure': '10 Meter Walking at Maximal Speed', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed \\[m/s\\]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.'}], 'secondaryOutcomes': [{'measure': 'Walking Index for Spinal Cord Injury II', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.'}, {'measure': 'Berg Balance Scale', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.'}, {'measure': 'Spinal Cord Independence Measure III', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.'}, {'measure': 'Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.'}, {'measure': 'Manual Muscle Test of the Lower Extremity', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.'}, {'measure': 'Pain on a Visual Analogue Scale', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.'}, {'measure': 'Response Time of the Lower Extremities', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.'}, {'measure': 'Falls Efficacy Scale', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.'}, {'measure': 'Figure of Eight Test', 'timeFrame': 'Baseline, after intervention (4 weeks)', 'description': 'The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to \\[m/s\\]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ASIA C and D'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '24401143', 'type': 'DERIVED', 'citation': 'Labruyere R, van Hedel HJ. Strength training versus robot-assisted gait training after incomplete spinal cord injury: a randomized pilot study in patients depending on walking assistance. J Neuroeng Rehabil. 2014 Jan 9;11:4. doi: 10.1186/1743-0003-11-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to investigate whether gait specific robotic supported bodyweight supported treadmill training and lower extremity strength training have similar beneficial effects on walking function and other outcomes.', 'detailedDescription': 'Although task-specific training has been promoted during the last years to improve function, recent studies showed that after an incomplete spinal cord injury, strength, but not complex movement coordination, is affected. In this randomized cross-over trial we investigate the effectiveness of a task-specific 4 week Lokomat training with a 4 week (unspecific) lower extremity muscle strength training on walking-related and other outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Time since lesion \\> 1 year\n* Outdoor mobility SCIM III \\< 5\n* Stable walking capacity\n\nExclusion Criteria:\n\n* participating on other training studies\n* osteoporosis\n* psychiatric diseases\n* epilepsia\n* body weight \\> 130 kg\n* cardiac pacemaker'}, 'identificationModule': {'nctId': 'NCT01087918', 'briefTitle': 'Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effects of Automated Treadmill Training and Lower Extremity Strength Training on Walking-related and Other Outcomes in Subjects With Chronic Incomplete Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'EK-21/2008'}, 'secondaryIdInfos': [{'id': 'CLI006/2 extension', 'type': 'OTHER_GRANT', 'domain': 'Spinal Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First RAGT, then strength training', 'description': '16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.', 'interventionNames': ['Device: RAGT', 'Other: Strength Training']}, {'type': 'EXPERIMENTAL', 'label': 'First strength training, then RAGT', 'description': '16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.', 'interventionNames': ['Device: RAGT', 'Other: Strength Training']}], 'interventions': [{'name': 'RAGT', 'type': 'DEVICE', 'description': '16 sessions / 4 times/week / 45 minutes Lokomat training', 'armGroupLabels': ['First RAGT, then strength training', 'First strength training, then RAGT']}, {'name': 'Strength Training', 'type': 'OTHER', 'description': '16 sessions / 4 times/week / 45 minutes lower extremity strength training', 'armGroupLabels': ['First RAGT, then strength training', 'First strength training, then RAGT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Balgrist University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Huub van Hedel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}