Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty

NCT ID: NCT03302832

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-10-01

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.

Conditions

Knee Osteoarthritis; Knee Arthritis; Knee Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Care Physical Therapy

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.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: 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.

Physical Therapy and in-Home Equipment

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.

Group Type: EXPERIMENTAL

Physical Therapy

Intervention Type: 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

Intervention Type: 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

Interventions

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.

Intervention Type: OTHER

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

Intervention Type: OTHER

Other Intervention Names

Total Range Exerciser Arc; T-REX Arc

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

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Campbell University, Incorporated

OTHER

Sponsor Role: lead

Responsible Party

Bradley Myers

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bradley Myers, PT, DPT, DSc

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

EmergeOrtho

Durham, North Carolina, United States

Countries

United States

Other Identifiers

313

Identifier Type: -

Identifier Source: org_study_id