Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty

Sponsor

Campbell University, Incorporated (Other)

Overall Status

Completed

CT.gov ID

NCT03302832

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis Knee Arthritis Knee Arthropathy	Other: Physical Therapy Other: In-home Exercise Equipment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized clinical trialRandomized clinical trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2017

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Experimental: 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.	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. 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 Other Names: Total Range Exerciser Arc T-REX Arc

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Experimental: 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.

Other: Physical Therapy

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

Other Names:

Total Range Exerciser Arc

T-REX Arc

Outcome Measures

Primary Outcome Measures

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) [Pre-surgery to 3 months post-surgery]
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

Secondary Outcome Measures

Self-reported home exercise compliance/adherence [1 month post-surgery, 2 months post-surgery, 3 months post-surgery]
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.
Change in Knee Active Range of Motion (AROM) [Pre-surgery to 3 months post-surgery]
Measurement of the range of motion that the participant can perform (in degrees) when maximally bending and straightening the knee.
Change in Knee Passive Range of Motion (PROM) [Pre-surgery to 3 months post-surgery]
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.
Change in Timed Up-and-Go Test (TUG) [Pre-surgery to 3 months post-surgery]
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.
Change in 6-minute Walk Test (6MWT) [Pre-surgery to 3 months post-surgery]
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.
Change in 30 second Chair Stand Test (30s-CST) [Pre-surgery to 3 months post-surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EmergeOrtho	Durham	North Carolina	United States	27704

Sponsors and Collaborators

Campbell University, Incorporated

Investigators

Principal Investigator: Bradley Myers, PT, DPT, DSc, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bradley Myers, Assistant Professor, Campbell University, Incorporated

ClinicalTrials.gov Identifier:

NCT03302832

Other Study ID Numbers:

First Posted:

Oct 5, 2017

Last Update Posted:

Jan 27, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bradley Myers, Assistant Professor, Campbell University, Incorporated

Total Knee Arthroplasty

Total Knee Replacement

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Joint Diseases

Study Results

No Results Posted as of Jan 27, 2020