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Completed

NCT Number: NCT03302832

Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty

Rehabilitation after Total Knee Arthroplasty surgery involves physical therapy services to address limitations in range of motion, strength, and participation in normal daily activities. This investigation will compare the outcomes from standard physical therapy intervention in comparison to reduced frequency physical therapy sessions supplemented with in-home exercise equipment.

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Key information

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EmergeOrtho

Durham, North Carolina, 27704, United States

About this study

Total knee arthroplasty (TKA) is a common surgical procedure for individuals experiencing pain and reduced physical abilities related to knee pain, most commonly osteoarthritis. Common physical impairments associated with post-operative TKA rehabilitation include: reduced knee range of motion (ROM), reduced strength, reduced participation in activities of daily living, and pain. TKA surgery is routinely paired with physical therapy (PT) interventions post-operatively in order to facilitate recovery for patients electing to undergo this intervention. The Total Range Exerciser (T-REX) is a medical device aimed at reducing the need for post-operative physical therapy services while promoting outcomes.

A successful outcome after total knee arthroplasty requires symptom relief and restoration of physical function. Measurement of pain and function can be achieved through patient-reported outcomes measures and objective functional testing. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported outcomes measure intended to capture the individual patient's perception of progress throughout the rehabilitative process. Objective measurements of physical function are necessary to quantify the magnitude of physical impairment associated with the patient's perceived status. Physical function can be measured through standardized assessment of knee ROM, strength, and ambulation. The purpose of this study is to evaluate the effectiveness of standard physical therapy compared to reduced frequency physical therapy supplemented with the (T-REX) after in total knee arthroplasty in subjective and objective measurements of physical function.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individual is to undergo TKA by a licensed physician at Participating hospital group
  • Participating primary health insurance provider
  • Patient is < 64.5 years of age
  • Willingness to participate in study protocol

Exclusion criteria

  • Previous or current history of cancer
  • High risk for cardiovascular disease as determined by the American College of Sports Medicine
  • Individuals with documented mental, psychiatric, or emotional disabilities
  • Inability to read and write in English

Treatment and study plan

Physical Therapy

Other

Physical therapy includes both the in-person and home-based interventions prescribed for each individual participant in order to maximize overall patient outcomes including: ambulation, range of motion, strength, functional activities, pain, swelling, balance, patient safety, and other items within the scope of physical therapy practice.

In-home Exercise Equipment

Other

The in-home exercise component of the study will supplement physical therapy services. This exercise equipment will be utilized daily for up to 90 minutes as guided by the healthcare team

Other names: Total Range Exerciser Arc, T-REX Arc

Primary outcomes

  1. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Pre-surgery to 3 months post-surgery

    The KOOS measurement is a patient-reported questionnaire that contains 42 questions covering 5 categories (pain, symptoms, activities of daily living, sports and recreation, and quality of life

Secondary outcomes

  1. Self-reported home exercise compliance/adherence

    Time frame: 1 month post-surgery, 2 months post-surgery, 3 months post-surgery

    Basic questions regarding the percent compliance with home exercises, amount of exercise time per week, and amount of days the participant performed exercise each week.

  2. Change in Knee Active Range of Motion (AROM)

    Time frame: Pre-surgery to 3 months post-surgery

    Measurement of the range of motion that the participant can perform (in degrees) when maximally bending and straightening the knee.

  3. Change in Knee Passive Range of Motion (PROM)

    Time frame: Pre-surgery to 3 months post-surgery

    Measurement of the range of motion (in degrees) that the participant's knee can maximally bend and straighten as a result of a manually applied movement.

  4. Change in Timed Up-and-Go Test (TUG)

    Time frame: Pre-surgery to 3 months post-surgery

    The TUG is a physical performance test that consists of the participant rising from a chair, ambulating 9 meters, turning around, returning to the chair and sitting. It is recorded in seconds.

  5. Change in 6-minute Walk Test (6MWT)

    Time frame: Pre-surgery to 3 months post-surgery

    The 6MWT is an assessment of longer duration ambulation and cardiorespiratory endurance. The test measurement is the total amount of distance that the participant ambulates within a 6-minute period.

  6. Change in 30 second Chair Stand Test (30s-CST)

    Time frame: Pre-surgery to 3 months post-surgery

    The 30s-CST is a test of strength, endurance and functional balance. The maximum number of sit to stand repetitions performed over a 30 second period represents the score for this test. Pre-test positioning includes placement of a 44 cm (17 inch) chair, measured from floor to seat surface, against a wall to inhibit movement of the chair during the test.

Sponsors and collaborators

Lead sponsor

Campbell University, Incorporated

Other

Registry information

Official study title

Effectiveness of Reduced Frequency Physical Therapy Supplemented With In-home Exercise Equipment Compared to Standard Care Physical Therapy in Total Knee Arthroplasty

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2017
Registry last updated
Jan 27, 2020

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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