Total Knee Arthroplasty
Conditions
Brief summary
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.
Interventions
DEVICEInterACTION
InterACTION guided home exercise program paired with standard of care physical therapy
Physical therapy rehabilitation program
Sponsors
James J. Irrgang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Between ages 40 to 80 years of age; 2. Have undergone primary unilateral total knee arthroplasty; 3. Being referred for post-operative outpatient physical therapy; 4. Agree to and able to perform pre-defined exercises that they would normally perform in a physical rehabilitation program.
Exclusion criteria
1. Patients with BMI \>40 at the time of surgery; 2. Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of rehabilitation exercises; 3. Individuals who cannot physically receive or understand audio and visual feedback from the joint motion tracking system during or after performance of rehabilitation exercises; 4. Individuals who are discharged post-operatively to a skilled nursing facility instead of to their residence;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation. | 10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Satisfied With InterACTION Device | 10 weeks | Subjects in the interACTION group were asked Would you consider using the InterACTION device if you had to do rehabilitation again in the future? |
| Number of Participants That Complied With Rehabilitation Program | 10 weeks | 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. |
| Performance Based Outcome Measures | 10 weeks | 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. |
| Range of Motion (Extension) | baseline and 10 weeks | Extension of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees. |
| Range of Motion (Flexion) | baseline and 10 weeks | Flexion of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| 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 | 12 |
| Total | 25 |
Baseline characteristics
| Characteristic | Total | Standard Physical Therapy | Rehabilitation With InterACTION |
|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 7.1 | 65.9 years STANDARD_DEVIATION 7.6 | 65.8 years STANDARD_DEVIATION 6.6 |
| Current Smoker | 1 Participants | 1 Participants | 0 Participants |
| Education College graduate | 6 Participants | 2 Participants | 4 Participants |
| Education Graduate degree | 7 Participants | 1 Participants | 6 Participants |
| Education High school grad | 5 Participants | 3 Participants | 2 Participants |
| Education Some college | 4 Participants | 4 Participants | 0 Participants |
| Education Some graduate school | 3 Participants | 2 Participants | 1 Participants |
| Education Some high school | 0 Participants | 0 Participants | 0 Participants |
| Employment Status Regular full time | 7 Participants | 4 Participants | 3 Participants |
| Employment Status Regular part time | 1 Participants | 1 Participants | 0 Participants |
| Employment Status Retired due to health | 1 Participants | 0 Participants | 1 Participants |
| Employment Status Retired not due to health | 13 Participants | 6 Participants | 7 Participants |
| Employment Status Semi-retired | 1 Participants | 0 Participants | 1 Participants |
| Employment Status Temporary retired due to health | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 12 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital status Married | 19 Participants | 8 Participants | 11 Participants |
| Marital status Separated | 1 Participants | 1 Participants | 0 Participants |
| Marital status Single | 3 Participants | 1 Participants | 2 Participants |
| Marital status Widowed | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 12 Participants | 10 Participants |
| Sex: Female, Male Female | 11 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 14 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 0 / 13 | 0 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
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.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rehabilitation With InterACTION | Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation. | 0.013 ratio | Standard Deviation 0.007 |
| Standard Physical Therapy | Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation. | 0.018 ratio | Standard Deviation 0.009 |
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.
Time frame: 10 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rehabilitation With InterACTION | Number of Participants That Complied With Rehabilitation Program | Greater than 90% | 6 Participants |
| Rehabilitation With InterACTION | Number of Participants That Complied With Rehabilitation Program | 71-90% | 4 Participants |
| Rehabilitation With InterACTION | Number of Participants That Complied With Rehabilitation Program | 51-70% | 0 Participants |
| Rehabilitation With InterACTION | Number of Participants That Complied With Rehabilitation Program | 31-50% | 0 Participants |
| Rehabilitation With InterACTION | Number of Participants That Complied With Rehabilitation Program | 0-30% | 0 Participants |
| Rehabilitation With InterACTION | Number of Participants That Complied With Rehabilitation Program | Missing Compliance Data | 0 Participants |
| Standard Physical Therapy | Number of Participants That Complied With Rehabilitation Program | 0-30% | 0 Participants |
| Standard Physical Therapy | Number of Participants That Complied With Rehabilitation Program | Greater than 90% | 5 Participants |
| Standard Physical Therapy | Number of Participants That Complied With Rehabilitation Program | 31-50% | 1 Participants |
| Standard Physical Therapy | Number of Participants That Complied With Rehabilitation Program | 71-90% | 2 Participants |
| Standard Physical Therapy | Number of Participants That Complied With Rehabilitation Program | Missing Compliance Data | 2 Participants |
| Standard Physical Therapy | Number of Participants That Complied With Rehabilitation Program | 51-70% | 0 Participants |
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?
Time frame: 10 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rehabilitation With InterACTION | Number of Subjects Satisfied With InterACTION Device | Yes | 11 Participants |
| Rehabilitation With InterACTION | Number of Subjects Satisfied With InterACTION Device | No | 0 Participants |
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.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rehabilitation With InterACTION | Performance Based Outcome Measures | -0.0071 z-score | Standard Deviation 1.02 |
| Standard Physical Therapy | Performance Based Outcome Measures | 0.028 z-score | Standard Deviation 0.64 |
Secondary
Range of Motion (Extension)
Extension of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.
Time frame: baseline and 10 weeks
Population: The total number analyzed represents the subjects that did not drop out of the study and completed the 10 weeks follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rehabilitation With InterACTION | Range of Motion (Extension) | Baseline Active Extension | 5.3 degrees | Standard Deviation 5.6 |
| Rehabilitation With InterACTION | Range of Motion (Extension) | 10 weeks Active Extension | 1.6 degrees | Standard Deviation 2.5 |
| Standard Physical Therapy | Range of Motion (Extension) | Baseline Active Extension | 1.1 degrees | Standard Deviation 3.4 |
| Standard Physical Therapy | Range of Motion (Extension) | 10 weeks Active Extension | 1.7 degrees | Standard Deviation 2.5 |
Secondary
Range of Motion (Flexion)
Flexion of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.
Time frame: baseline and 10 weeks
Population: The total number analyzed represents the subjects that did not drop out of the study and completed the 10 weeks follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rehabilitation With InterACTION | Range of Motion (Flexion) | Baseline Active Flexion | 93.0 degrees | Standard Deviation 17.6 |
| Rehabilitation With InterACTION | Range of Motion (Flexion) | 10 weeks Active Flexion | 120.8 degrees | Standard Deviation 8.6 |
| Standard Physical Therapy | Range of Motion (Flexion) | Baseline Active Flexion | 91.5 degrees | Standard Deviation 19.3 |
| Standard Physical Therapy | Range of Motion (Flexion) | 10 weeks Active Flexion | 123.1 degrees | Standard Deviation 4.9 |