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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation with InterACTION | Experimental | After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device. |
|
| Standard Physical Therapy | Other | After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InterACTION | Device | InterACTION guided home exercise program paired with standard of care physical therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation. | 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. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Complied With Rehabilitation Program | 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. | 10 weeks |
| Number of Subjects Satisfied With InterACTION Device |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33121204 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rehabilitation With InterACTION | Subjects underwent a rehabilitation program with InterACTION. |
| FG001 | Standard Physical Therapy | Subjects underwent standard of care physical therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline assessments were performed approximately 2 to 4 weeks after subjects underwent TKA.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rehabilitation With InterACTION | After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device. InterACTION: InterACTION guided home exercise program paired with standard of care physical therapy |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation. | 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. | Posted | Mean | Standard Deviation | ratio | 10 weeks |
|
Adverse events were monitored from the start of the intervention until 10 weeks follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rehabilitation With InterACTION | After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device. InterACTION: InterACTION guided home exercise program paired with standard of care physical therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James J. Irrgang | University of Pittsburgh | (412) 383-9865 | jirrgang@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2018 | Jan 9, 2019 | Prot_SAP_000.pdf |
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| Standard of Care Physical Therapy | Other | Physical therapy rehabilitation program |
|
Subjects in the interACTION group were asked "Would you consider using the InterACTION device if you had to do rehabilitation again in the future?" |
| 10 weeks |
| Performance Based Outcome Measures | 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. | 10 weeks |
| Range of Motion (Extension) | Extension of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees. | baseline and 10 weeks |
| Range of Motion (Flexion) | Flexion of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees. | baseline and 10 weeks |
| Standard Physical Therapy |
After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program. Standard of Care Physical Therapy: Physical therapy rehabilitation program |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
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| Current Smoker | Count of Participants | Participants |
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| OG001 | Standard Physical Therapy | After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program. Standard of Care Physical Therapy: Physical therapy rehabilitation program |
|
|
| Secondary | Number of Participants That Complied With Rehabilitation Program | 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. | Posted | Count of Participants | Participants | 10 weeks |
|
|
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| Secondary | Number of Subjects Satisfied With InterACTION Device | Subjects in the interACTION group were asked "Would you consider using the InterACTION device if you had to do rehabilitation again in the future?" | Posted | Count of Participants | Participants | 10 weeks |
|
|
|
| Secondary | Performance Based Outcome Measures | 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. | Posted | Mean | Standard Deviation | z-score | 10 weeks |
|
|
|
| Secondary | Range of Motion (Extension) | Extension of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees. | The total number analyzed represents the subjects that did not drop out of the study and completed the 10 weeks follow-up assessment. | Posted | Mean | Standard Deviation | degrees | baseline and 10 weeks |
|
|
|
| Secondary | Range of Motion (Flexion) | Flexion of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees. | The total number analyzed represents the subjects that did not drop out of the study and completed the 10 weeks follow-up assessment. | Posted | Mean | Standard Deviation | degrees | baseline and 10 weeks |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Standard Physical Therapy | After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program. Standard of Care Physical Therapy: Physical therapy rehabilitation program | 0 | 12 | 0 | 12 | 0 | 12 |
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| 51-70% |
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| 31-50% |
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| 0-30% |
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| Missing Compliance Data |
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