Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2026-02-25 @ 3:02 AM
Study NCT ID:
NCT02646761
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2015-08-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following TKA
Sponsor:
Organization:
Raw JSON
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Irrgang', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored from the start of the intervention until 10 weeks follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'Rehabilitation With InterACTION', 'description': 'After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.\n\nInterACTION: InterACTION guided home exercise program paired with standard of care physical therapy', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Physical Therapy', 'description': 'After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.\n\nStandard of Care Physical Therapy: Physical therapy rehabilitation program', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation With InterACTION', 'description': 'After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.\n\nInterACTION: InterACTION guided home exercise program paired with standard of care physical therapy'}, {'id': 'OG001', 'title': 'Standard Physical Therapy', 'description': 'After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.\n\nStandard of Care Physical Therapy: Physical therapy rehabilitation program'}], 'classes': [{'categories': [{'measurements': [{'value': '0.013', 'spread': '0.007', 'groupId': 'OG000'}, {'value': '0.018', 'spread': '0.009', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'The value was calculated the ratio of the difference between the 10 week and baseline Activities of Daily Living Scale (ADLS) of the Knee Outcome Survey divided by the total charges for the physical therapy treatment sessions. The ADLS is a 14-item measure of symptoms and activity limitations for individuals with a variety of knee impairments. Items are scored from 0 to 4, and the total score is the sum of all the items divided by 70 and multiplied by 100. The ADLS score ranges from 0 to 100 with higher scores representing less symptoms and greater levels of activity. Higher ratio of the change in the ADLS score to the costs for rehabilitation represents greater value.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Complied With Rehabilitation Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation With InterACTION', 'description': 'After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.\n\nInterACTION: InterACTION guided home exercise program paired with standard of care physical therapy'}, {'id': 'OG001', 'title': 'Standard Physical Therapy', 'description': 'After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.\n\nStandard of Care Physical Therapy: Physical therapy rehabilitation program'}], 'classes': [{'categories': [{'title': 'Greater than 90%', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '71-90%', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '51-70%', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '31-50%', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '0-30%', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing Compliance Data', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 weeks', 'description': 'Compliance with the use of the InterACTION device was measured by reports generated from the device. Subjects in the Standard Physical Therapy Group completed exercise logs that were monitored at each study visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Satisfied With InterACTION Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation With InterACTION', 'description': 'After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.\n\nInterACTION: InterACTION guided home exercise program paired with standard of care physical therapy'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 weeks', 'description': 'Subjects in the interACTION group were asked "Would you consider using the InterACTION device if you had to do rehabilitation again in the future?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Performance Based Outcome Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation With InterACTION', 'description': 'After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.\n\nInterACTION: InterACTION guided home exercise program paired with standard of care physical therapy'}, {'id': 'OG001', 'title': 'Standard Physical Therapy', 'description': 'After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.\n\nStandard of Care Physical Therapy: Physical therapy rehabilitation program'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0071', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '0.028', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': "The performance based measures included the 6-minute walk test (measured as distance in meters); stair climb test (measured as time in seconds divided by the number of steps); timed up and go test (measured in seconds); and unilateral balance test (measured in seconds). To combine the 4 performance-based outcome measures into a single composite score, the score for each test was converted to a z score (individual's score - overall mean)/overall standard deviation. As such, the z-score represents the number of SD deviations an individual's score is above or below the overall study mean. A z-score of 0 implies the participants score is the same as the mean score. A z-score of 0.1 would indicate that the participant's z score is .1 (10%) of a standard deviation above or below the overall mean. The average of the z scores for each performance-based outcome measure as the unit of analysis.", 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Range of Motion (Extension)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation With InterACTION', 'description': 'After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.\n\nInterACTION: InterACTION guided home exercise program paired with standard of care physical therapy'}, {'id': 'OG001', 'title': 'Standard Physical Therapy', 'description': 'After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.\n\nStandard of Care Physical Therapy: Physical therapy rehabilitation program'}], 'classes': [{'title': 'Baseline Active Extension', 'categories': [{'measurements': [{'value': '5.3', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': '10 weeks Active Extension', 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 10 weeks', 'description': 'Extension of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The total number analyzed represents the subjects that did not drop out of the study and completed the 10 weeks follow-up assessment.'}, {'type': 'SECONDARY', 'title': 'Range of Motion (Flexion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation With InterACTION', 'description': 'After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.\n\nInterACTION: InterACTION guided home exercise program paired with standard of care physical therapy'}, {'id': 'OG001', 'title': 'Standard Physical Therapy', 'description': 'After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.\n\nStandard of Care Physical Therapy: Physical therapy rehabilitation program'}], 'classes': [{'title': 'Baseline Active Flexion', 'categories': [{'measurements': [{'value': '93.0', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '91.5', 'spread': '19.3', 'groupId': 'OG001'}]}]}, {'title': '10 weeks Active Flexion', 'categories': [{'measurements': [{'value': '120.8', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '123.1', 'spread': '4.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 10 weeks', 'description': 'Flexion of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The total number analyzed represents the subjects that did not drop out of the study and completed the 10 weeks follow-up assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rehabilitation With InterACTION', 'description': 'Subjects underwent a rehabilitation program with InterACTION.'}, {'id': 'FG001', 'title': 'Standard Physical Therapy', 'description': 'Subjects underwent standard of care physical therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Subject Withdrew Before Baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Baseline Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': '5-week Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'preAssignmentDetails': 'A total of 47 subjects were assessed for eligibility for the study. Nine were deemed ineligible and 38 were randomized into one of the 2 study arms. Subjects were recruited and randomized prior to surgery \\& the baseline assessment was done approximately 2 to 4 weeks after surgery.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rehabilitation With InterACTION', 'description': 'After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.\n\nInterACTION: InterACTION guided home exercise program paired with standard of care physical therapy'}, {'id': 'BG001', 'title': 'Standard Physical Therapy', 'description': 'After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.\n\nStandard of Care Physical Therapy: Physical therapy rehabilitation program'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '65.9', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '65.9', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital status', 'classes': [{'categories': [{'title': 'Married', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Separated', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Single', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Widowed', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Some high school', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'High school grad', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Some college', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'College graduate', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Some graduate school', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Graduate degree', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment Status', 'classes': [{'categories': [{'title': 'Retired due to health', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Retired not due to health', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Temporary retired due to health', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Semi-retired', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Regular full time', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Regular part time', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current Smoker', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline assessments were performed approximately 2 to 4 weeks after subjects underwent TKA.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-18', 'size': 123926, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-09T13:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-14', 'studyFirstSubmitDate': '2015-08-14', 'resultsFirstSubmitDate': '2018-12-20', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-14', 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation.', 'timeFrame': '10 weeks', 'description': 'The value was calculated the ratio of the difference between the 10 week and baseline Activities of Daily Living Scale (ADLS) of the Knee Outcome Survey divided by the total charges for the physical therapy treatment sessions. The ADLS is a 14-item measure of symptoms and activity limitations for individuals with a variety of knee impairments. Items are scored from 0 to 4, and the total score is the sum of all the items divided by 70 and multiplied by 100. The ADLS score ranges from 0 to 100 with higher scores representing less symptoms and greater levels of activity. Higher ratio of the change in the ADLS score to the costs for rehabilitation represents greater value.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants That Complied With Rehabilitation Program', 'timeFrame': '10 weeks', 'description': 'Compliance with the use of the InterACTION device was measured by reports generated from the device. Subjects in the Standard Physical Therapy Group completed exercise logs that were monitored at each study visit.'}, {'measure': 'Number of Subjects Satisfied With InterACTION Device', 'timeFrame': '10 weeks', 'description': 'Subjects in the interACTION group were asked "Would you consider using the InterACTION device if you had to do rehabilitation again in the future?"'}, {'measure': 'Performance Based Outcome Measures', 'timeFrame': '10 weeks', 'description': "The performance based measures included the 6-minute walk test (measured as distance in meters); stair climb test (measured as time in seconds divided by the number of steps); timed up and go test (measured in seconds); and unilateral balance test (measured in seconds). To combine the 4 performance-based outcome measures into a single composite score, the score for each test was converted to a z score (individual's score - overall mean)/overall standard deviation. As such, the z-score represents the number of SD deviations an individual's score is above or below the overall study mean. A z-score of 0 implies the participants score is the same as the mean score. A z-score of 0.1 would indicate that the participant's z score is .1 (10%) of a standard deviation above or below the overall mean. The average of the z scores for each performance-based outcome measure as the unit of analysis."}, {'measure': 'Range of Motion (Extension)', 'timeFrame': 'baseline and 10 weeks', 'description': 'Extension of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.'}, {'measure': 'Range of Motion (Flexion)', 'timeFrame': 'baseline and 10 weeks', 'description': 'Flexion of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '33121204', 'type': 'DERIVED', 'citation': 'Bell KM, Onyeukwu C, Smith CN, Oh A, Devito Dabbs A, Piva SR, Popchak AJ, Lynch AD, Irrgang JJ, McClincy MP. A Portable System for Remote Rehabilitation Following a Total Knee Replacement: A Pilot Randomized Controlled Clinical Study. Sensors (Basel). 2020 Oct 27;20(21):6118. doi: 10.3390/s20216118.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if home-based therapy with monitoring via telemedicine can overcome many barriers to compliance and improve rehabilitation. Patients undergoing total knee arthroplasty will be followed for 10 weeks during their outpatient physical therapy course. Subjects will undergo standard physical therapy or physical therapy paired with InterACTION for 10 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between ages 40 to 80 years of age;\n2. Have undergone primary unilateral total knee arthroplasty;\n3. Being referred for post-operative outpatient physical therapy;\n4. Agree to and able to perform pre-defined exercises that they would normally perform in a physical rehabilitation program.\n\nExclusion Criteria:\n\n1. Patients with BMI \\>40 at the time of surgery;\n2. Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of rehabilitation exercises;\n3. Individuals who cannot physically receive or understand audio and visual feedback from the joint motion tracking system during or after performance of rehabilitation exercises;\n4. Individuals who are discharged post-operatively to a skilled nursing facility instead of to their residence;'}, 'identificationModule': {'nctId': 'NCT02646761', 'briefTitle': 'interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following TKA', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'PRO15060281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation with InterACTION', 'description': 'After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.', 'interventionNames': ['Device: InterACTION']}, {'type': 'OTHER', 'label': 'Standard Physical Therapy', 'description': 'After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.', 'interventionNames': ['Other: Standard of Care Physical Therapy']}], 'interventions': [{'name': 'InterACTION', 'type': 'DEVICE', 'description': 'InterACTION guided home exercise program paired with standard of care physical therapy', 'armGroupLabels': ['Rehabilitation with InterACTION']}, {'name': 'Standard of Care Physical Therapy', 'type': 'OTHER', 'description': 'Physical therapy rehabilitation program', 'armGroupLabels': ['Standard Physical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'James J. Irrgang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD, PT', 'investigatorFullName': 'James J. Irrgang', 'investigatorAffiliation': 'University of Pittsburgh'}}}}