Trial Outcomes & Findings for interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following TKA (NCT NCT02646761)
NCT ID: NCT02646761
Last Updated: 2019-02-05
Results Overview
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.
COMPLETED
NA
38 participants
10 weeks
2019-02-05
Participant Flow
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.
Participant milestones
| Measure |
Rehabilitation With InterACTION
Subjects underwent a rehabilitation program with InterACTION.
|
Standard Physical Therapy
Subjects underwent standard of care physical therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
|
Overall Study
Subject Withdrew Before Baseline
|
5
|
8
|
|
Overall Study
Baseline Assessment
|
13
|
12
|
|
Overall Study
5-week Assessment
|
12
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following TKA
Baseline characteristics by cohort
| Measure |
Rehabilitation With InterACTION
n=13 Participants
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
|
Standard Physical Therapy
n=12 Participants
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
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
65.9 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
65.9 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Marital status
Married
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Marital status
Separated
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital status
Single
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Marital status
Widowed
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
Some high school
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education
High school grad
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
Some college
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
College graduate
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education
Some graduate school
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
Graduate degree
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Employment Status
Retired due to health
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Employment Status
Retired not due to health
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Employment Status
Temporary retired due to health
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Employment Status
Semi-retired
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Employment Status
Regular full time
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Employment Status
Regular part time
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Current Smoker
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksThe 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.
Outcome measures
| Measure |
Rehabilitation With InterACTION
n=10 Participants
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
|
Standard Physical Therapy
n=10 Participants
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
|
|---|---|---|
|
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
|
0.018 ratio
Standard Deviation 0.009
|
SECONDARY outcome
Timeframe: 10 weeksCompliance 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.
Outcome measures
| Measure |
Rehabilitation With InterACTION
n=10 Participants
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
|
Standard Physical Therapy
n=10 Participants
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
|
|---|---|---|
|
Number of Participants That Complied With Rehabilitation Program
Greater than 90%
|
6 Participants
|
5 Participants
|
|
Number of Participants That Complied With Rehabilitation Program
71-90%
|
4 Participants
|
2 Participants
|
|
Number of Participants That Complied With Rehabilitation Program
51-70%
|
0 Participants
|
0 Participants
|
|
Number of Participants That Complied With Rehabilitation Program
31-50%
|
0 Participants
|
1 Participants
|
|
Number of Participants That Complied With Rehabilitation Program
0-30%
|
0 Participants
|
0 Participants
|
|
Number of Participants That Complied With Rehabilitation Program
Missing Compliance Data
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 10 weeksSubjects in the interACTION group were asked "Would you consider using the InterACTION device if you had to do rehabilitation again in the future?"
Outcome measures
| Measure |
Rehabilitation With InterACTION
n=11 Participants
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
|
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
|
|---|---|---|
|
Number of Subjects Satisfied With InterACTION Device
Yes
|
11 Participants
|
—
|
|
Number of Subjects Satisfied With InterACTION Device
No
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 10 weeksThe 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.
Outcome measures
| Measure |
Rehabilitation With InterACTION
n=10 Participants
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
|
Standard Physical Therapy
n=10 Participants
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
|
|---|---|---|
|
Performance Based Outcome Measures
|
-0.0071 z-score
Standard Deviation 1.02
|
0.028 z-score
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: baseline and 10 weeksPopulation: The total number analyzed represents the subjects that did not drop out of the study and completed the 10 weeks follow-up assessment.
Extension of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.
Outcome measures
| Measure |
Rehabilitation With InterACTION
n=10 Participants
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
|
Standard Physical Therapy
n=10 Participants
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
|
|---|---|---|
|
Range of Motion (Extension)
Baseline Active Extension
|
5.3 degrees
Standard Deviation 5.6
|
1.1 degrees
Standard Deviation 3.4
|
|
Range of Motion (Extension)
10 weeks Active Extension
|
1.6 degrees
Standard Deviation 2.5
|
1.7 degrees
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: baseline and 10 weeksPopulation: The total number analyzed represents the subjects that did not drop out of the study and completed the 10 weeks follow-up assessment.
Flexion of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.
Outcome measures
| Measure |
Rehabilitation With InterACTION
n=10 Participants
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
|
Standard Physical Therapy
n=10 Participants
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
|
|---|---|---|
|
Range of Motion (Flexion)
10 weeks Active Flexion
|
120.8 degrees
Standard Deviation 8.6
|
123.1 degrees
Standard Deviation 4.9
|
|
Range of Motion (Flexion)
Baseline Active Flexion
|
93.0 degrees
Standard Deviation 17.6
|
91.5 degrees
Standard Deviation 19.3
|
Adverse Events
Rehabilitation With InterACTION
Standard Physical Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place