Osteoarthritis, KneeNCT04877873
Dual-task Gait Performance in People With Knee Osteoarthritis Before and After Knee Replacement Surgery
An observational study of Osteoarthritis, Knee, run by University of Haifa at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Gait analysis pre- and post- surgery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Oct 2020to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Candidates for TKR surgery at HaEmek Medical Center.
Who may be able to join
- Able to walk at least for 1 minute with no assistive device
- Able to understand and complete simple instructions
Who cannot join
- Diagnosed dementia
- Diseases impairing balance
- Diagnosed rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Gait analysis pre- and post- surgery
- Keywords
- Total knee replacement, Cognitive load, Gait, Proprioception, Dual task
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysis pre- and post- surgeryBehavioural
None (observational)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait speed
Change in gait speed as measured using an instrumented mat
Measured: One month prior to surgery, 4.5 months post-surgery
Change in gait variability
Change in coefficient of variation of stride time and stride length, as measured using an instrumented mat
Measured: One month prior to surgery, 4.5 months post-surgery
Secondary outcomes (6)
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)
Measured: One month prior to surgery, 4.5 months post-surgery
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
Measured: One month prior to surgery, 4.5 months post-surgery
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.
Measured: One month prior to surgery, 4.5 months post-surgery
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
Measured: One month prior to surgery, 4.5 months post-surgery
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
Measured: One month prior to surgery, 4.5 months post-surgery
Cognitive function
Montreal Cognitive Assessment (MoCA) is a test of cognitive function. Ranging from 0 to 30, better scores denote better cognitive function.
Measured: One month prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start19 Oct 2020
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Emek Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877873
- Sponsor's protocol ID
- KneeOADualTask
- Status last verified
- May 2022
- First submitted
- 2 May 2021
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Azzam I, Rozen N, Eliyahu A, Dabby D, Elbaz A, Mor A, Krasovsky T. The Effect of Total Knee Replacement on Dual-Task Gait Performance in Older Adults. Phys Ther. 2024 Aug 2;104(8):pzae067. doi: 10.1093/ptj/pzae067.
PubMed 38691445
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-task Gait Performance in People With Knee Osteoarthritis Before and After Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT04877873
- Acronym / sponsor ID
- KneeOADualTask
- Conditions
- Osteoarthritis, Knee
- Keywords
- Total knee replacement, Cognitive load, Gait, Proprioception, Dual task
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Emek Medical Center
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Candidates for TKR surgery at HaEmek Medical Center.
Key inclusion criteria (2 listed)
- Able to walk at least for 1 minute with no assistive device
- Able to understand and complete simple instructions
Key exclusion criteria (3 listed)
- Diagnosed dementia
- Diseases impairing balance
- Diagnosed rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait analysis pre- and post- surgeryNone (observational) | Behavioural | – |
Primary outcome
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
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
6 secondary outcomes
Change in Joint position sense
Time frame: 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
Change in dynamic Balance
Time frame: 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
Change in movement reinvestment
Time frame: One month prior to surgery, 4.5 months post-surgery
Cognitive function
Time frame: One month prior to surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Derived from this study: PubMed 38691445Azzam I, Rozen N, Eliyahu A, Dabby D, Elbaz A, Mor A, Krasovsky T. The Effect of Total Knee Replacement on Dual-Task Gait Performance in Older Adults. Phys Ther. 2024 Aug 2;104(8):pzae067. doi: 10.1093/ptj/pzae067.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait speed (time frame: One month prior to surgery, 4.5 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04877873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.