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Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis, Knee Arthritis, Knee Arthropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Therapy
In-home Exercise Equipment
Sponsored by
Campbell University, Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total Knee Arthroplasty, Total Knee Replacement

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • EmergeOrtho

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care Physical Therapy

Physical Therapy and in-Home Equipment

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 22, 2017
Last Updated
January 23, 2020
Sponsor
Campbell University, Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT03302832
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campbell University, Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Arthritis, Knee Arthropathy
Keywords
Total Knee Arthroplasty, Total Knee Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care Physical Therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Physical Therapy and in-Home Equipment
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
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
Intervention Name(s)
In-home Exercise Equipment
Other Intervention Name(s)
Total Range Exerciser Arc, T-REX Arc
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
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
Time Frame
Pre-surgery to 3 months post-surgery
Secondary Outcome Measure Information:
Title
Self-reported home exercise compliance/adherence
Description
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.
Time Frame
1 month post-surgery, 2 months post-surgery, 3 months post-surgery
Title
Change in Knee Active Range of Motion (AROM)
Description
Measurement of the range of motion that the participant can perform (in degrees) when maximally bending and straightening the knee.
Time Frame
Pre-surgery to 3 months post-surgery
Title
Change in Knee Passive Range of Motion (PROM)
Description
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.
Time Frame
Pre-surgery to 3 months post-surgery
Title
Change in Timed Up-and-Go Test (TUG)
Description
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.
Time Frame
Pre-surgery to 3 months post-surgery
Title
Change in 6-minute Walk Test (6MWT)
Description
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.
Time Frame
Pre-surgery to 3 months post-surgery
Title
Change in 30 second Chair Stand Test (30s-CST)
Description
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.
Time Frame
Pre-surgery to 3 months post-surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Myers, PT, DPT, DSc
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
EmergeOrtho
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data is intended to be shared with other researchers

Learn more about this trial

Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty

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