interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following TKA

Study Overview
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Brief Summary
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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.

Official Title
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interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following Total Knee Arthroplasty

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Device: InterACTION
* Other: Standard of Care Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between ages 40 to 80 years of age; Have undergone primary unilateral total knee arthroplasty; Being referred for post-operative outpatient physical therapy; Agree to and able to perform pre-defined exercises that they would normally perform in a physical rehabilitation program. Exclusion Criteria: Patients with BMI >40 at the time of surgery; Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of rehabilitation exercises; Individuals who cannot physically receive or understand audio and visual feedback from the joint motion tracking system during or after performance of rehabilitation exercises; Individuals who are discharged post-operatively to a skilled nursing facility instead of to their residence;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation with InterACTION<br>After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device. | Device: InterACTION<br>* InterACTION guided home exercise program paired with standard of care physical therapy<br>|
| Other: Standard Physical Therapy<br>After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program. | Other: Standard of Care Physical Therapy<br>* Physical therapy rehabilitation program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |