Virtual vs. Traditional Physical Therapy Following Total Knee Replacement
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|ClinicalTrials.gov Identifier: NCT02914210|
Recruitment Status : Completed
First Posted : September 26, 2016
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
The goals of this research study are the following:
- To compare the effects of tele-rehabilitation-supported physical therapy versus traditional home and/or clinic-based physical therapy for total knee replacement (TKR) on 90-day health service use costs.
- To compare tele-rehabilitation-supported physical therapy and traditional physical therapy on patient-centered outcomes
- To explore whether individual patient characteristics are associated with differential improvement from 6 to 12 weeks assessed by patient-reported outcomes.
|Condition or disease||Intervention/treatment||Phase|
|Total Knee Replacement||Device: Virtual physical therapy rehabilitation program Other: No intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||306 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS)|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Virtual physical therapy
Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists
Device: 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.
Other: No intervention
Traditional physical therapy delivered in clinic or via home-health visits
- Cost Difference in US Dollars [ Time Frame: 12 weeks ]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.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 6 weeks and 12 weeks ]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.
- Range of Motion [ Time Frame: 6 weeks ]Knee range of motion [lower (extension) and upper range of motion (flexion)] at 6 weeks
- 10-meter Gait Speed [ Time Frame: 6 weeks ]Gait speed 6 weeks after surgery
- Pain Score [ Time Frame: 12 weeks ]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.
- Report of Falls [ Time Frame: 12 weeks ]Any fall reported between hospital discharge and 12-week follow-up (yes/no)
- Re-hospitalization [ Time Frame: 12 weeks ]Re-hospitalizations since hospital discharge (total count)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores [ Time Frame: 6 weeks and 12 weeks ]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.
- Physical Activity [ Time Frame: 6 weeks and 12 weeks ]Physical activity (duration of moderate exercise in total minutes per week)
- Return to Work [ Time Frame: 6 weeks and 12 weeks ]Return to work (yes, modified schedule, or no) for those who stopped working prior to surgery
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Mental Health (MH) Score [ Time Frame: 12 weeks ]PROMIS mental health score at 12 weeks, on a scale of 0 to 20 with higher scores indicating better mental health.
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Health (PH) Score [ Time Frame: 12 weeks ]PROMIS physical health score at 12 weeks, on a scale of 0 to 20, with higher scores indicating better physical health.
- Satisfaction With Physical Function [ Time Frame: 12 weeks ]Score on Satisfaction with Physical Function questionnaire through 12 weeks after surgery, on a scale of 0 to 6, with 6 being higher satisfaction.
- Satisfaction With Tele-rehab Platform [ Time Frame: 12 weeks ]Satisfaction with tele-rehab platform, on scale of 0 to 10, with 10 being highly satisfied.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914210
|United States, North Carolina|
|University of North Carolina Orhthopedics|
|Chapel Hill, North Carolina, United States, 27514|
|Durham, North Carolina, United States, 27705|
|Greensboro, North Carolina, United States, 27408|
|Raleigh, North Carolina, United States, 27612|
|Principal Investigator:||Janet Bettger, ScD||Duke Clinical Research Institute, Duke Dept of Orthopaedic Surgery|