Clinical trial NCT03302832: Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty
Official title: Effectiveness of Reduced Frequency Physical Therapy Supplemented With In-home Exercise Equipment Compared to Standard Care Physical Therapy in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Knee Arthritis
Knee Arthropathy
Keywords: Total Knee Arthroplasty
Total Knee Replacement
Lead sponsor: Campbell University, Incorporated
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 51
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Pre-surgery to 3 months post-surgery
Secondary outcomes:
measure: Self-reported home exercise compliance/adherence
timeFrame: 1 month post-surgery, 2 months post-surgery, 3 months post-surgery
measure: Change in Knee Active Range of Motion (AROM)
timeFrame: Pre-surgery to 3 months post-surgery
measure: Change in Knee Passive Range of Motion (PROM)
timeFrame: Pre-surgery to 3 months post-surgery
measure: Change in Timed Up-and-Go Test (TUG)
timeFrame: Pre-surgery to 3 months post-surgery
measure: Change in 6-minute Walk Test (6MWT)
timeFrame: Pre-surgery to 3 months post-surgery
measure: Change in 30 second Chair Stand Test (30s-CST)
timeFrame: Pre-surgery to 3 months post-surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: EmergeOrtho
state: North Carolina
Study officials:
affiliation: Assistant Professor
name: Bradley Myers, PT, DPT, DSc
role: PRINCIPAL_INVESTIGATOR
References: