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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877873
• Other study ID #: KneeOADualTask
• Status: Completed
• Start date: October 19, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: May 2022
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Gait analysis pre- and post- surgery
None (observational)

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Emek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gait speed	Change in gait speed as measured using an instrumented mat	One month prior to surgery, 4.5 months post-surgery
Primary	Change in gait variability	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	Change in Joint position sense	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
Secondary	Change in Pain, stiffness, physical function	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
Secondary	Change in dynamic Balance	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
Secondary	Change in balance self-efficacy	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
Secondary	Change in movement reinvestment	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
Secondary	Cognitive function	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