An interventional study of Physical Therapy and In-home Exercise Equipment in Knee Osteoarthritis, Knee Arthritis and Knee Arthropathy, sponsored by Campbell University, Incorporated. Completed at 1 site in United States. Open to participants aged Up to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by Campbell University, Incorporated · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
The participants randomized to the Standard Care Physical Therapy group will begin outpatient physical therapy services after discharge from inpatient care, on day 4 or 5 post-Total Knee Arthroplasty. The frequency of sessions will be 2-3 x per week for the initial 2 weeks, followed by 2 x per week until the culmination of physical therapy. The frequency and duration of sessions will be determined by the treating physical therapist based upon the clinical needs and progress of the specific participant.
Other: Physical Therapy
The participants randomized to the experimental group will begin outpatient physical therapy services after discharge from inpatient care, on day 4 or 5 post-Total Knee Arthroplasty. The frequency of physical therapy sessions will be 1 x per week throughout the duration of the study period. In addition, this group will utilize in-home exercise equipment daily.
Other: Physical Therapy · Other: In-home Exercise Equipment
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.
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
Also known as: Total Range Exerciser Arc, T-REX Arc
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
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
Time frame: Pre-surgery to 3 months post-surgery
Self-reported home exercise compliance/adherence
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.
Time frame: 1 month post-surgery, 2 months post-surgery, 3 months post-surgery
Change in Knee Active Range of Motion (AROM)
Measurement of the range of motion that the participant can perform (in degrees) when maximally bending and straightening the knee.
Time frame: Pre-surgery to 3 months post-surgery
Change in Knee Passive Range of Motion (PROM)
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.
Time frame: Pre-surgery to 3 months post-surgery
Change in Timed Up-and-Go Test (TUG)
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.
Time frame: Pre-surgery to 3 months post-surgery
Change in 6-minute Walk Test (6MWT)
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.
Time frame: Pre-surgery to 3 months post-surgery
Change in 30 second Chair Stand Test (30s-CST)
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.
Time frame: Pre-surgery to 3 months post-surgery
Plan to share: No — No data is intended to be shared with other researchers
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Campbell University, Incorporated