Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty

Campbell University, Incorporated

Status: Completed

Conditions: Knee Arthritis; Knee Osteoarthritis; Knee Arthropathy

Treatments: Other: Physical Therapy; Other: In-home Exercise Equipment

Study type: Interventional

Funder types: Other

Identifiers

NCT03302832

313

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: Under 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Standard Care Physical Therapy

Active Comparator group

Description:

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.

Treatment:

Other: Physical Therapy

Physical Therapy and in-Home Equipment

Experimental group

Description:

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.

Treatment:

Other: Physical Therapy

Other: In-home Exercise Equipment