Virtual physical therapy rehabilitation program
DeviceVirtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home
NCT Number: NCT02914210
The goals of this research study are the following:
1. 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. 2. To compare tele-rehabilitation-supported physical therapy and traditional physical therapy on patient-centered outcomes 3. To explore whether individual patient characteristics are associated with differential improvement from 6 to 12 weeks assessed by patient-reported outcomes.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
University of North Carolina Orhthopedics, Chapel Hill, North Carolina, United States
This study will compare the effects on health service use costs of tele-rehabilitation-supported physical therapy versus traditional home and/or clinic-based physical therapy following total knee replacement (TKR) surgery. It will also examine standard post-surgical clinical measures to confirm non-inferiority of outcomes between groups. A total of 300 patients will receive standard pre- and post-surgical medical care from their healthcare providers, and be randomized to receive pre-surgery rehabilitation exercises ("pre-hab") and post-discharge physical therapy provided via either a home-based tele-rehabilitation platform (intervention group, n=150) or home-health and clinic-based physical therapy regimen (control group, n=150). Data will be collected by sites at enrollment, baseline, hospital discharge, and 6 weeks following surgery. Patients will complete telephone surveys regarding their health and knee function at baseline, 6 weeks, and 3 months after surgery. Patients will also keep a diary from hospital discharge through 3 months documenting healthcare utilization and progress toward a personal recovery goal. Diary information will be collected over the phone concurrently with administration of the 6-week and 3-month surveys. The episode for analysis will be from surgery through 3 months post-discharge, in alignment with the Centers for Medicare and Medicaid Services Comprehensive Care for Joint Replacement (CJR) bundled payment model. Physical risks or benefits to patients for participating in this study are as expected from standard pre- and post-surgical physical therapy associated with total knee replacement surgery. The low risk of loss of confidentiality for all subjects will be minimized using appropriate safeguards.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home
Traditional physical therapy delivered in clinic or via home-health visits
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.
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.
Time frame: 6 weeks
Knee range of motion [lower (extension) and upper range of motion (flexion)] at 6 weeks
Time frame: 6 weeks
Gait speed 6 weeks after surgery
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.
Time frame: 12 weeks
Any fall reported between hospital discharge and 12-week follow-up (yes/no)
Time frame: 12 weeks
Re-hospitalizations since hospital discharge (total count)
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.
Time frame: 6 weeks and 12 weeks
Physical activity (duration of moderate exercise in total minutes per week)
Time frame: 6 weeks and 12 weeks
Return to work (yes, modified schedule, or no) for those who stopped working prior to surgery
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.
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.
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.
Time frame: 12 weeks
Satisfaction with tele-rehab platform, on scale of 0 to 10, with 10 being highly satisfied.
Duke University
Other
Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS)
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