Dual-task Gait Performance in People With Knee Osteoarthritis Before and After Knee Replacement Surgery

May 11, 2023 updated by: University of Haifa

Knee Osteoarthritis (OA) is one of the most common conditions causing disability and limitation in the elderly population, with 13% of women and 10% of men over the age of 60 suffering from symptomatic knee osteoarthritis. Pain and other symptoms of OA significantly affect the quality of life, manifesting itself in pain, decreased range of motion, functional limitation and change in gait patterns.

Total Knee Replacement Surgery (TKR) is the most common solution for patients with advanced cartilage erosion and is considered a successful surgery with high satisfaction rates (about 80%). The surgery becomes necessary when pain limits the daily functioning and impairs the quality of life and after the failure of conservative treatment.

Still, patients undergoing TKR suffer in the first period after surgery from pain, decreased balance and proprioceptive impairment. Despite the improvement in pain and function, the rates of falls after surgery do not change drastically and remain high.

About a third of older adults fall each year, leading to fractures, functional decline and in some cases death. Walking is a complex task, and with advancing age walking becomes less automatic and requires additional attention. Among adults, it is known that an increased risk of falls is associated with reduced ability to perform complex walking tasks, such as walking while talking or crossing obstacles.

After TKR, most falls occur while walking due to slipping / tripping. In addition, proprioceptive impairment, pain and poor balance are associated with an increased risk of falling after TKR. The mechanism underlying these effects may be increased allocation of cognitive resources to walking. Thus, this study will examine the ability of people before and after TKR to perform complex walking tasks, in order to examine the change in attention allocation to walking following surgery. It is hypothesized that after surgery, the ability to walk while performing an additional task will be lower than prior to surgery.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Afula, Israel
        • HaEmek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Candidates for TKR surgery at HaEmek Medical Center.

Description

Inclusion Criteria:

  • Able to walk at least for 1 minute with no assistive device
  • Able to understand and complete simple instructions

Exclusion Criteria:

  • Diagnosed dementia
  • Diseases impairing balance
  • Diagnosed rheumatoid arthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gait speed
Time Frame: One month prior to surgery, 4.5 months post-surgery
Change in gait speed as measured using an instrumented mat
One month prior to surgery, 4.5 months post-surgery
Change in gait variability
Time Frame: One month prior to surgery, 4.5 months post-surgery
Change in coefficient of variation of stride time and stride length, as measured using an instrumented mat
One month prior to surgery, 4.5 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Joint position sense
Time Frame: One month prior to surgery, 4.5 months post-surgery
Estimation of knee position using the Physiological Profile Assessment (PPA). Specifically, the difference between intended knee flexion angle and achieved flexion angle is calculated in degrees (worse performance is identified via larger difference)
One month prior to surgery, 4.5 months post-surgery
Change in Pain, stiffness, physical function
Time Frame: One month prior to surgery, 4.5 months post-surgery
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Is a self-report questionnaire of pain, stiffness and physical function in people with knee osteoarthritis. Scores range 0-20 for pain, 0-8 for stiffness and 0-68 for physical function
One month prior to surgery, 4.5 months post-surgery
Change in dynamic Balance
Time Frame: One month prior to surgery, 4.5 months post-surgery
Mini Balance Evaluation Systems Test (Mini-BesTest) is a functional test of dynamic balance. Scores range from 0 to 28, with better scores indicating better balance.
One month prior to surgery, 4.5 months post-surgery
Change in balance self-efficacy
Time Frame: One month prior to surgery, 4.5 months post-surgery
The Activities-specific Balance Confidence (ABC) Scale is a self-reported measure of balance self-efficacy. Ranging from 0 to 100, better scores indicate better balance self-efficacy
One month prior to surgery, 4.5 months post-surgery
Change in movement reinvestment
Time Frame: One month prior to surgery, 4.5 months post-surgery
Movement reinvestment will be measured using the Movement Specific Reinvestment Scale (MSRS), a self-report measure of conscious monitoring of movement. Scores range from 10 to 60, with higher scores denoting more conscious movement monitoring
One month prior to surgery, 4.5 months post-surgery
Cognitive function
Time Frame: One month prior to surgery
Montreal Cognitive Assessment (MoCA) is a test of cognitive function. Ranging from 0 to 30, better scores denote better cognitive function.
One month prior to surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

May 2, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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