Trial Outcomes & Findings for Virtual vs. Traditional Physical Therapy Following Total Knee Replacement (NCT NCT02914210)

NCT ID: NCT02914210

Last Updated: 2021-11-02

Results Overview

Difference in total health service use costs at 12-weeks postoperative between patients who receive tele-rehab-supported PT versus traditional home and/or clinic-based PT for TKR.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 306 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2021-11-02

Participant Flow

Participant milestones

Measure	Virtual Physical Therapy Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Overall Study STARTED	153	153
Overall Study COMPLETED	143	144
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual vs. Traditional Physical Therapy Following Total Knee Replacement

Baseline characteristics by cohort

Measure	Virtual Physical Therapy n=151 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=153 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits	Total n=304 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 7.7 • n=5 Participants	65.1 years STANDARD_DEVIATION 9.2 • n=7 Participants	65.2 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants	100 Participants n=7 Participants	190 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	53 Participants n=7 Participants	114 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	128 Participants n=5 Participants	119 Participants n=7 Participants	247 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	16 Participants n=5 Participants	28 Participants n=7 Participants	44 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · Multiple	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Race · Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino Ethnicity · Yes	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino Ethnicity · No or Not Reported	147 Participants n=5 Participants	153 Participants n=7 Participants	300 Participants n=5 Participants
Region of Enrollment United States	151 participants n=5 Participants	153 participants n=7 Participants	304 participants n=5 Participants
RAPT Score	10.1 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	9.7 units on a scale STANDARD_DEVIATION 1.6 • n=7 Participants	9.9 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Patients randomized and receiving eligible surgery, and completing the study through 12 weeks post surgery.

Difference in total health service use costs at 12-weeks postoperative between patients who receive tele-rehab-supported PT versus traditional home and/or clinic-based PT for TKR.

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=144 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Cost Difference in US Dollars	1050.00 US Dollars Interval 900.0 to 1200.0	2805.00 US Dollars Interval 1644.5 to 4505.0

SECONDARY outcome

Timeframe: 6 weeks and 12 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions

Survey regarding health [Knee Injury and Osteoarthritis Outcome Score (KOOS)] for pain, symptoms, activities of daily living, function in sports and recreation, and knee-related quality of life (QOL) at 6 weeks and 12 weeks, scored from 0 to 100. Higher score indicates better outcomes.

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=144 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Knee Injury and Osteoarthritis Outcome Score (KOOS) 6 weeks	61.0 score on a scale Standard Deviation 11.5	61.8 score on a scale Standard Deviation 13.5
Knee Injury and Osteoarthritis Outcome Score (KOOS) 12 weeks	69.6 score on a scale Standard Deviation 12.1	67.2 score on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: 6 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and having range of motion measured at specified time point.

Knee range of motion [lower (extension) and upper range of motion (flexion)] at 6 weeks

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=144 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Range of Motion Knee Extension (straight leg)	2.5 degrees from parallel to floor Standard Deviation 3.6	2.9 degrees from parallel to floor Standard Deviation 3.4
Range of Motion Knee Flexion (bent leg)	114.5 degrees from parallel to floor Standard Deviation 15.3	111.4 degrees from parallel to floor Standard Deviation 16.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and having gait speed measured.

Gait speed 6 weeks after surgery

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=144 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
10-meter Gait Speed	1.0 minutes Standard Deviation 0.3	1.0 minutes Standard Deviation 0.3

SECONDARY outcome

Timeframe: 12 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and responding to survey question regarding pain.

Non-inferiority safety endpoint: pain score at 12 weeks. Measured on scale from 0 to 10, with 0 being no pain and 10 being worst pain imaginable.

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=144 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Pain Score	2.7 score on a scale Standard Deviation 2.0	3.0 score on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 12 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and answering survey question regarding falls.

Any fall reported between hospital discharge and 12-week follow-up (yes/no)

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=144 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Report of Falls	19.4 percentage of patients	14.6 percentage of patients

SECONDARY outcome

Timeframe: 12 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.

Re-hospitalizations since hospital discharge (total count)

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=144 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Re-hospitalization	0.1 number of rehospitalizations per patient Standard Deviation 0.3	0.2 number of rehospitalizations per patient Standard Deviation 0.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks and 12 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.

Scores in KOOS sub-domains of pain, symptoms, activities of daily living (ADL), sports and recreation, and quality of life (QOL). Each sub-domain score can be normalized to values ranging from 0 to 100. Higher scores denote better outcomes.

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=144 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores Pain (6 weeks)	66.6 score on a scale Standard Deviation 15.6	68.7 score on a scale Standard Deviation 17.1
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores Symptoms (6 weeks)	54.7 score on a scale Standard Deviation 11.5	53.9 score on a scale Standard Deviation 11.8
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores Function/Daily Living (6 weeks)	76.4 score on a scale Standard Deviation 13.9	75.7 score on a scale Standard Deviation 16.6
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores Sports/Recreation (6 weeks)	51.2 score on a scale Standard Deviation 29.4	50.2 score on a scale Standard Deviation 31.0
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores Quality of Life (6 weeks)	46.5 score on a scale Standard Deviation 18.7	50.5 score on a scale Standard Deviation 19.6
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores Pain (12 weeks)	78.4 score on a scale Standard Deviation 14.0	76.7 score on a scale Standard Deviation 17.5
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores Symptoms (12 weeks)	54.9 score on a scale Standard Deviation 12.2	53.9 score on a scale Standard Deviation 11.1
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores Function/Daily Living (12 weeks)	82.7 score on a scale Standard Deviation 13.6	80.9 score on a scale Standard Deviation 17.7
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores Sports/Recreation (12 weeks)	75.6 score on a scale Standard Deviation 109.2	61.5 score on a scale Standard Deviation 28.3
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores Quality of Life (12 weeks)	61.8 score on a scale Standard Deviation 18.8	58.3 score on a scale Standard Deviation 20.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks and 12 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.

Physical activity (duration of moderate exercise in total minutes per week)

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=144 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Physical Activity 6 weeks	40 minutes per week Interval 0.0 to 150.0	4 minutes per week Interval 0.0 to 90.0
Physical Activity 12 weeks	60 minutes per week Interval 0.0 to 150.0	60 minutes per week Interval 0.0 to 120.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks and 12 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.

Return to work (yes, modified schedule, or no) for those who stopped working prior to surgery

Outcome measures

Measure	Virtual Physical Therapy n=68 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=65 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Return to Work 6 weeks · Yes	15 Participants	14 Participants
Return to Work 6 weeks · Modified Schedule	17 Participants	18 Participants
Return to Work 6 weeks · No	36 Participants	32 Participants
Return to Work 6 weeks · Not recorded	0 Participants	1 Participants
Return to Work 12 weeks · Yes	41 Participants	42 Participants
Return to Work 12 weeks · Modified Schedule	9 Participants	12 Participants
Return to Work 12 weeks · No	13 Participants	11 Participants
Return to Work 12 weeks · Not recorded	5 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.

PROMIS mental health score at 12 weeks, on a scale of 0 to 20 with higher scores indicating better mental health.

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=144 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Patient-Reported Outcomes Measurement Information System (PROMIS) - Mental Health (MH) Score	16.6 score on a scale Standard Deviation 2.5	16.1 score on a scale Standard Deviation 3.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.

PROMIS physical health score at 12 weeks, on a scale of 0 to 20, with higher scores indicating better physical health.

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=144 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Health (PH) Score	15.3 score on a scale Standard Deviation 2.4	14.8 score on a scale Standard Deviation 2.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.

Score on Satisfaction with Physical Function questionnaire through 12 weeks after surgery, on a scale of 0 to 6, with 6 being higher satisfaction.

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy n=144 Participants No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Satisfaction With Physical Function	4.9 score on a scale Standard Deviation 1.3	4.9 score on a scale Standard Deviation 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Patients randomized and receiving eligible surgery, completing study through 12 weeks, using the virtual platform at least once, and providing response to survey question.

Satisfaction with tele-rehab platform, on scale of 0 to 10, with 10 being highly satisfied.

Outcome measures

Measure	Virtual Physical Therapy n=143 Participants Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists Virtual physical therapy rehabilitation program: Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home	Traditional Physical Therapy No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. No intervention: Traditional physical therapy delivered in clinic or via home-health visits
Satisfaction With Tele-rehab Platform Promoters (score 9-10)	83.3 percentage of participants	—
Satisfaction With Tele-rehab Platform Detractors (score 0-6)	9.5 percentage of participants	—
Satisfaction With Tele-rehab Platform Neutral (score 7-8)	7.2 percentage of participants	—

Adverse Events

Virtual Physical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Physical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Janet Bettger, ScD

Duke Clinical Research Institute

Phone: 919-613-0379

Email: janet.bettger@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place