Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302832
• Other study ID #: 313
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: January 2020
• Source: Campbell University, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthritis
• Knee Arthropathy
• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Physical Therapy
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
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

Locations

Country	Name	City	State
United States	EmergeOrtho	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Campbell University, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pre-surgery to 3 months post-surgery
Secondary	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.	1 month post-surgery, 2 months post-surgery, 3 months post-surgery
Secondary	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.	Pre-surgery to 3 months post-surgery
Secondary	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.	Pre-surgery to 3 months post-surgery
Secondary	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.	Pre-surgery to 3 months post-surgery
Secondary	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.	Pre-surgery to 3 months post-surgery
Secondary	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.	Pre-surgery to 3 months post-surgery