Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty

NCT03302832 | Completed

• 1 other identifier: 313
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Knee Arthritis; Knee Arthropathy

Keywords

Total Knee Arthroplasty; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Self-reported home exercise compliance/adherence

  1 month post-surgery, 2 months post-surgery, 3 months post-surgery

• Change in Knee Active Range of Motion (AROM)

  Pre-surgery to 3 months post-surgery

• Change in Knee Passive Range of Motion (PROM)

  Pre-surgery to 3 months post-surgery

• Change in Timed Up-and-Go Test (TUG)

  Pre-surgery to 3 months post-surgery

• Change in 6-minute Walk Test (6MWT)

  Pre-surgery to 3 months post-surgery

Study Arms (2)

Standard Care Physical Therapy

ACTIVE COMPARATOR

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 and in-Home Equipment

EXPERIMENTAL

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

Interventions

Physical Therapy 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; Standard Care Physical Therapy

In-home Exercise Equipment 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

Also known as: Total Range Exerciser Arc, T-REX Arc

Physical Therapy and in-Home Equipment

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Campbell University, Incorporated: lead

Study Sites (1)

EmergeOrtho

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Bradley Myers, PT, DPT, DSc

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 5, 2017
• Study Start: October 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)