Clinical trial NCT04877873: Dual-task Gait Performance in People With Knee Osteoarthritis Before and After Knee Replacement Surgery
Official title: Dual-task Gait Performance in People With Knee Osteoarthritis Before and After Knee Replacement Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Keywords: Total knee replacement
Cognitive load
Gait
Proprioception
Dual task
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Emek Medical Center
First posted: 2021-05-07
Enrollment: 38
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Candidates for TKR surgery at HaEmek Medical Center.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Gait speed
timeFrame: One month prior to surgery, 4.5 months post-surgery
measure: Change in gait variability
timeFrame: One month prior to surgery, 4.5 months post-surgery
Secondary outcomes:
measure: Change in Joint position sense
timeFrame: One month prior to surgery, 4.5 months post-surgery
measure: Change in Pain, stiffness, physical function
timeFrame: One month prior to surgery, 4.5 months post-surgery
measure: Change in dynamic Balance
timeFrame: One month prior to surgery, 4.5 months post-surgery
measure: Change in balance self-efficacy
timeFrame: One month prior to surgery, 4.5 months post-surgery
measure: Change in movement reinvestment
timeFrame: One month prior to surgery, 4.5 months post-surgery
measure: Cognitive function
timeFrame: One month prior to surgery
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
References: