Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-04 @ 6:52 PM
Study NCT ID:
NCT02496702
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2015-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Playware Technology for Balance Training
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jdje@elektro.dtu.dk', 'phone': '+45 45 25 39 29', 'title': 'Jari Due Jessen', 'organization': 'Technical University of Denmark, Center for Playware'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Training', 'description': 'The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).\n\nTraining on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'No training.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Test Score of 6 Minute Walking Test at Week 14.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Training', 'description': 'The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).\n\nTraining on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles'}, {'id': 'OG001', 'title': 'Control', 'description': 'No training.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '-13.6', 'upperLimit': '15.7'}, {'value': '0.568', 'groupId': 'OG001', 'lowerLimit': '-18.2', 'upperLimit': '19.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at week 14', 'description': 'Numbers of meters that can be walked in 6 minutes around a 50-yard (45.7 meters) course. Baseline score compared to score at week 14.', 'unitOfMeasure': 'm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Test Score of 30-second Chair Stand at Week 14.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Training', 'description': 'The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).\n\nTraining on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles'}, {'id': 'OG001', 'title': 'Control', 'description': 'No training.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.05', 'groupId': 'OG000', 'lowerLimit': '0.513', 'upperLimit': '3.58'}, {'value': '0.455', 'groupId': 'OG001', 'lowerLimit': '-0.375', 'upperLimit': '1.28'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at week 14', 'description': 'Number of full stands that can be completed in 30 seconds with arms folded across chest. Baseline score compared to score at week 14.', 'unitOfMeasure': 'Full chair stands per 30 seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Test Score of 8-Foot Up-and-Go at Week 14.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Training', 'description': 'The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).\n\nTraining on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles'}, {'id': 'OG001', 'title': 'Control', 'description': 'No training.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.38', 'groupId': 'OG000', 'lowerLimit': '-2.77', 'upperLimit': '0.0207'}, {'value': '-0.0473', 'groupId': 'OG001', 'lowerLimit': '-0.837', 'upperLimit': '0.742'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at week 14', 'description': 'Number of seconds required to get up from a seated position, walk 8 feet (2.44 meters), turn, and return to seated position. Baseline score compared to score at week 14.', 'unitOfMeasure': 'seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Test Score of Line Walk at Week 14.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Training', 'description': 'The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).\n\nTraining on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles'}, {'id': 'OG001', 'title': 'Control', 'description': 'No training.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.23', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '3.57'}, {'value': '1.09', 'groupId': 'OG001', 'lowerLimit': '-0.539', 'upperLimit': '2.72'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at week 14', 'description': 'Number of steps a person can do on a line directly after the foot without touching outside the line. Baseline score compared to score at week 14.', 'unitOfMeasure': 'Steps', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Test Score of Static Balance at Week 14.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Training', 'description': 'The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).\n\nTraining on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles'}, {'id': 'OG001', 'title': 'Control', 'description': 'No training.'}], 'timeFrame': 'Baseline and at week 14', 'description': 'Static Balance will be measured using Wii Balance Board, which have proven to be a valid measure of balance (Sgró 2014). This measure will be done using an application developed by Francesco Sgró and colleagues (Sgró 2014). Baseline score compared to score at week 14.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}, {'type': 'SECONDARY', 'title': 'Adherence to Training, Composite Outcome Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Training', 'description': 'The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).\n\nTraining on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles'}, {'id': 'OG001', 'title': 'Control', 'description': 'No training.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '85.6', 'upperLimit': '95.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At week 14', 'description': 'Adherence to the training will be measured by registering the number of times the participants participate and how much they participate at each session.', 'unitOfMeasure': 'percentage of sessions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Motivation for Training', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Training', 'description': 'The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).\n\nTraining on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles'}, {'id': 'OG001', 'title': 'Control', 'description': 'No training.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 14.', 'description': 'Semi-structured interviews will be done with the participant after the intervention to investigate the motivation of the IMT.', 'unitOfMeasure': 'percentage of wanting to continue', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acceptability of IMT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Training', 'description': 'The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).\n\nTraining on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles'}, {'id': 'OG001', 'title': 'Control', 'description': 'No training.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 14.', 'description': 'Semi-structured interviews will be done with the participant after the intervention to investigate the acceptability of the IMT', 'unitOfMeasure': 'percentage of happy to train on IMT', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Training', 'description': 'The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).\n\nTraining on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles'}, {'id': 'FG001', 'title': 'Control', 'description': 'No training.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Received Allocated Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did Not Receive Allocated Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Only partially tested', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Training', 'description': 'The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).\n\nTraining on Interactive Modulare Tiles: Training with the Interactive Modulare Tiles'}, {'id': 'BG001', 'title': 'Control', 'description': 'No training.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '83.14', 'spread': '6.69', 'groupId': 'BG000'}, {'value': '82.37', 'spread': '6.61', 'groupId': 'BG001'}, {'value': '82.73', 'spread': '6.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Timed Up and Go', 'classes': [{'categories': [{'measurements': [{'value': '12.24', 'spread': '5.13', 'groupId': 'BG000'}, {'value': '13.35', 'spread': '10.10', 'groupId': 'BG001'}, {'value': '12.80', 'spread': '7.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Seconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Chair Stand', 'classes': [{'categories': [{'measurements': [{'value': '9.23', 'spread': '4.47', 'groupId': 'BG000'}, {'value': '8.77', 'spread': '3.91', 'groupId': 'BG001'}, {'value': '9', 'spread': '4.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Chair stands per 30 seconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '6 Minute Walking Test', 'classes': [{'categories': [{'measurements': [{'value': '240.28', 'spread': '71.21', 'groupId': 'BG000'}, {'value': '237.18', 'spread': '94.77', 'groupId': 'BG001'}, {'value': '238.73', 'spread': '83.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Line Walk', 'classes': [{'categories': [{'measurements': [{'value': '2.37', 'spread': '4.36', 'groupId': 'BG000'}, {'value': '3.50', 'spread': '2.49', 'groupId': 'BG001'}, {'value': '2.93', 'spread': '3.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Steps', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.62', 'groupId': 'BG000', 'lowerLimit': '1.47', 'upperLimit': '1.78'}, {'value': '1.65', 'groupId': 'BG001', 'lowerLimit': '1.49', 'upperLimit': '1.88'}, {'value': '1.63', 'groupId': 'BG002', 'lowerLimit': '1.47', 'upperLimit': '1.88'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '68.33', 'spread': '13.22', 'groupId': 'BG000'}, {'value': '71.13', 'spread': '13.34', 'groupId': 'BG001'}, {'value': '69.73', 'spread': '13.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.17', 'spread': '5.21', 'groupId': 'BG000'}, {'value': '26.16', 'spread': '4.45', 'groupId': 'BG001'}, {'value': '26.16', 'spread': '4.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-01', 'studyFirstSubmitDate': '2015-07-07', 'resultsFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2015-07-10', 'lastUpdatePostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-01', 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Test Score of 6 Minute Walking Test at Week 14.', 'timeFrame': 'Baseline and at week 14', 'description': 'Numbers of meters that can be walked in 6 minutes around a 50-yard (45.7 meters) course. Baseline score compared to score at week 14.'}, {'measure': 'Change From Baseline in Test Score of 30-second Chair Stand at Week 14.', 'timeFrame': 'Baseline and at week 14', 'description': 'Number of full stands that can be completed in 30 seconds with arms folded across chest. Baseline score compared to score at week 14.'}, {'measure': 'Change From Baseline in Test Score of 8-Foot Up-and-Go at Week 14.', 'timeFrame': 'Baseline and at week 14', 'description': 'Number of seconds required to get up from a seated position, walk 8 feet (2.44 meters), turn, and return to seated position. Baseline score compared to score at week 14.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Test Score of Line Walk at Week 14.', 'timeFrame': 'Baseline and at week 14', 'description': 'Number of steps a person can do on a line directly after the foot without touching outside the line. Baseline score compared to score at week 14.'}, {'measure': 'Change From Baseline in Test Score of Static Balance at Week 14.', 'timeFrame': 'Baseline and at week 14', 'description': 'Static Balance will be measured using Wii Balance Board, which have proven to be a valid measure of balance (Sgró 2014). This measure will be done using an application developed by Francesco Sgró and colleagues (Sgró 2014). Baseline score compared to score at week 14.'}, {'measure': 'Adherence to Training, Composite Outcome Measure.', 'timeFrame': 'At week 14', 'description': 'Adherence to the training will be measured by registering the number of times the participants participate and how much they participate at each session.'}, {'measure': 'Motivation for Training', 'timeFrame': 'At week 14.', 'description': 'Semi-structured interviews will be done with the participant after the intervention to investigate the motivation of the IMT.'}, {'measure': 'Acceptability of IMT', 'timeFrame': 'At week 14.', 'description': 'Semi-structured interviews will be done with the participant after the intervention to investigate the acceptability of the IMT'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['exergaming', 'Senior Fitness Test'], 'conditions': ['Accidental Falls']}, 'referencesModule': {'references': [{'pmid': '25276497', 'type': 'BACKGROUND', 'citation': 'Lund HH, Jessen JD. Effects of Short-Term Training of Community-Dwelling Elderly with Modular Interactive Tiles. Games Health J. 2014 Oct 1;3(5):277-283. doi: 10.1089/g4h.2014.0028.'}, {'pmid': '28103811', 'type': 'DERIVED', 'citation': 'Jessen JD, Lund HH. Study protocol: effect of playful training on functional abilities of older adults - a randomized controlled trial. BMC Geriatr. 2017 Jan 19;17(1):27. doi: 10.1186/s12877-017-0416-5.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the use of Playware technology for balance training. Falling among elder is a costly problem. Research shows that training can help prevent falls. Pilot studies of the use of Interactive Modular Tiles (IMT) show that the participants can highly increase their physical abilities.\n\nThe interventions group will train using interactive modular tiles. The tiles include preprogrammed games that create playful training for the participants.\n\nThe control group will receive "usual care", which here refers to normal day activities.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time.', 'detailedDescription': "This study will investigate the use of one form of exergames called IMT how this compared to usual care of elderly people 70+. The trial will consist of two groups, one for training with the IMT and usual care that will receive the care provided to non-patients elderly, which at this moment is no additional treatment other than recommendations.\n\nThe study will be single blinded, randomized controlled trial. It will be funded by the patient@home project and Entertainment robotics. Concealed allocation and intention-to-treat analysis will be used. Measurements will be taken at baseline and after intervention. Upon acceptance the protocol will be registered in clinicaltrials.gov.\n\nThe trial's results will be reported using domains and categories described in the taxonomy developed by the Prevention of Falls Network Europe, to allow future synthesis of evidence, or study replication.\n\nThe intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe control group will not train."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community-dwelling\n* 70+ years\n\nExclusion Criteria:\n\n* A previous diagnosis of strong dementia or a cognitive decline that prevents the understanding of simple instructions or guidelines;\n* A previous stroke with a severe neurological impairment, such as loss of strength, and perceptual or language limitations;\n* A severe visual deficiency;\n* Inability to maintain a standing position, even with the use of a walking aid or other device;\n* Participating in rehabilitative training.'}, 'identificationModule': {'nctId': 'NCT02496702', 'acronym': 'IMT', 'briefTitle': 'Playware Technology for Balance Training', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Denmark'}, 'officialTitle': 'Efficacy of Interactive Modular Tiles Training Versus "Usual Care" on Physical Attributes Among Elder Adults 70+. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-15006703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training', 'description': 'The intervention is done in the form of groups of 4-5 participants per set of tiles, with 2-3 set of tiles at a time. As more set can be used it is possible to make groups of more people. The training will consist of 1.5-3 minutes of training (depending on the game) on tiles and the rest while the other 2-3 participants train (4-6 minutes of break). Then the participants will train for 1.5-3 minutes again until each participant have received a total of 13 minutes of training.\n\nThe intervention will be done 2 times a week for 12 weeks, each session lasting 1 hour and each participant receiving 13 minutes of training each time (see training plan).', 'interventionNames': ['Device: Training on Interactive Modulare Tiles']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No training.'}], 'interventions': [{'name': 'Training on Interactive Modulare Tiles', 'type': 'DEVICE', 'description': 'Training with the Interactive Modulare Tiles', 'armGroupLabels': ['Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2800', 'city': 'Kongens Lyngby', 'country': 'Denmark', 'facility': 'Technical University of Denmark', 'geoPoint': {'lat': 55.77044, 'lon': 12.50378}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Jari Due Jessen', 'investigatorAffiliation': 'Technical University of Denmark'}}}}