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Completed

NCT Number: NCT02914210

Virtual vs. Traditional Physical Therapy Following Total Knee Replacement

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina Orhthopedics, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years of age
  • Scheduled to have a non-traumatic TKR
  • Can be enrolled a minimum of 10 days prior to surgery (in-person visit)
  • Have a Risk Assessment and Prediction Tool (RAPT) score of ≥ 6 indicating expected discharge home after surgical hospitalization

Exclusion criteria

  • Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (comprehension)
  • Scheduled for staged bilateral TKR
  • Living in a nursing home prior to surgery

Treatment and study plan

Virtual physical therapy rehabilitation program

Device

Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home

No intervention

Other

Traditional physical therapy delivered in clinic or via home-health visits

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Range of Motion

    Time frame: 6 weeks

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

  3. 10-meter Gait Speed

    Time frame: 6 weeks

    Gait speed 6 weeks after surgery

  4. 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.

  5. Report of Falls

    Time frame: 12 weeks

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

  6. Re-hospitalization

    Time frame: 12 weeks

    Re-hospitalizations since hospital discharge (total count)

Other outcomes

  1. 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.

  2. Physical Activity

    Time frame: 6 weeks and 12 weeks

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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Reflexion Health, Inc.

Registry information

Official study title

Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2016
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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