Knee OsteoarthritisNCT06065410
The Effect of Intrinsic Focus on Gait Cycle and the Possible Confounding Effect of Noise in Patients With Knee Osteoarthritis
A study testing Baseline, Intrinsic focus and White noise in people with Knee Osteoarthritis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Patients with knee osteoarthritis may develop an antalgic gait over time due to pain in the knee, characterized by a decrease in the stance phase and stride length on the painful side. Gait asymmetry, which may lead to different musculoskeletal problems in the future, is observed in the patients. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Baseline, Intrinsic focus and White noise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 Apr 2023
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable general condition
- Good cooperation
- Diagnosed with knee osteoarthritis according to ACR criteria
- At least stage 2 unilateral or bilateral knee osteoarthritis according to Kellgren Lawrence staging
- Individuals >50 years of age
Who cannot join
- Hearing Impairment Scale ≥ 26
- Presence of a neurological, cardiac or orthopedic pathology that prevents walking
- The presence of another pathology other than knee osteoarthritis that affects the knee and causes pain
- Presence of diseases such as osteoarthritis, gout, rheumatoid arthritis affecting other joints in the lower extremity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Medicine
Ankara, 06560
About this study
Official title: Research Assistant Doctor
Patients with knee osteoarthritis may develop an antalgic gait over time due to pain in the knee, characterized by a decrease in the stance phase and stride length on the painful side. Gait asymmetry, which may lead to different musculoskeletal problems in the future, is observed in the patients. Gait symmetry can be achieved with gait retraining, and effective focus is required during training.
In the literature, there are many studies of the positive effects of white noise on focusing, but there are also studies that report that it reduces focusing.
Read more
Today, exercise training is usually performed in rehabilitation units or on treadmills. As there are important differences between walking on a treadmill and walking outdoors in terms of noise, uneven ground and visual stimuli, the place where walking training is performed does not reflect the outdoor environment.
It was aimed to investigate the effect of internal focusing on gait cycle and the effect of white noise and environmental sound on internal focusing in patients with knee osteoarthritis
Read the detailed description
A total of 40 patients between the ages of 50 and 75 years, who were admitted to the outpatient clinic of Gazi University Faculty of Medicine, Department of Physical Medicine and Rehabilitation or hospitalized in the ward and diagnosed with knee osteoarthritis according to ACR knee osteoarthritis criteria and had a Kellgren Lawrence staging of at least 2, were included.
The demographic data of the patients who were evaluated with the Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S) and had adequate hearing level were recorded, bilateral true leg lengths were measured and detailed knee examinations were performed. Lequesne Knee Osteoarthritis Severity Index, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lower Extremity Functional Scale (LEFS), 30 Second Sit to Stand Test and Timed Up and Go Test were applied to the patients who met the inclusion and exclusion criteria.
Patients walked at a speed of 0.40-0.45 m/s on a treadmill (Biodex Gait Trainer) where gait parameters were collected. Each patient walked at a constant speed for three minutes each in the baseline (without any instruction or sound), intrinsic focus (focusing on ensuring equal step lengths and step durations on both sides and symmetry between both steps), white noise (intrinsic focus accompanied by white noise) and environmental sound (intrinsic focus accompanied by environmental sound) conditions. After walking in each condition, gait parameters ( average step cycle, average step length, percentage of step length variability, percentage of left/right side stepping time and ambulation index) were recorded. The User Experience Questionnaire Short Form was adapted for our study to assess patients' experiences during intrinsically focused walking in white noise and environmental sound conditions. Patients were asked to rate their walking periods in white noise and environmental sound conditions in terms of inhibiting-supportive, inefficient-efficient, complex-simple, confusing-clear, boring-exciting, uninteresting-interesting, traditional-unique, and familiar-unusual characteristics.
- Conditions
- Knee Osteoarthritis
- Being tested
- Baseline, Intrinsic focus, White noise, environmental sound
- Keywords
- knee osteoarthritis, white noise, intrinsic focusing, environmental sound
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaselineOther
Walking without any instruction or sound
Intrinsic focusOther
Walking focusing on ensuring equal step lengths and step durations on both sides and symmetry between both steps
White noiseOther
Intrinsic focus accompanied by white noise
environmental soundOther
Intrinsic focus accompanied by environmental sound
| Study group | Role | What they receive |
|---|---|---|
| Patients with knee osteoarthritis | Experimental | Not described Receives: Other: Baseline; Other: Intrinsic focus; Other: White noise; Other: environmental sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average step cycle (cycle/second)
After walking in each condition, average step cycle was recorded (total of 4 conditions)
Measured: Evaluation at first visit of patients meeting the included criteria.12 minutes in total, with 3 minutes of assessment time in each walking condition
Average step length (m)
After walking in each condition, average step length was recorded (total of 4 conditions)
Measured: Evaluation at first visit of patients meeting the included criteria.12 minutes in total, with 3 minutes of assessment time in each walking condition
Percentage of step length variability (%)
After walking in each condition, percentage of step length variability was recorded (total of 4 conditions)
Measured: Evaluation at first visit of patients meeting the included criteria. 12 minutes in total, with 3 minutes of assessment time in each walking condition
Percentage of left/right side stepping time (%)
After walking in each condition, percentage of left/right side stepping time was recorded (total of 4 conditions)
Measured: Evaluation at first visit of patients meeting the included criteria.12 minutes in total, with 3 minutes of assessment time in each walking condition
Ambulation index
After walking in each condition, ambulation index was recorded (total of 4 conditions)
Measured: Evaluation at first visit of patients meeting the included criteria.12 minutes in total, with 3 minutes of assessment time in each walking condition
Secondary outcomes (1)
The User Experience Questionnaire Short Form
The User Experience Questionnaire Short Form was adapted for our study to assess patients' experiences during intrinsically focused walking in white noise and environmental sound conditions. Patients were asked to rate their walking periods in white noise and environmental sound conditions in terms of inhibiting-supportive, inefficient-efficient, complex-simple, confusing-clear, boring-exciting, uninteresting-interesting, traditional-unique, and familiar-unusual characteristics.
Measured: Evaluation was performed immediately after execution in white noise and environmentel sound conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Feb 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Between the ages of 50 and 75 years, who were admitted to the outpatient clinic of Gazi University Faculty of Medicine, Department of Physical Medicine and Rehabilitation or hospitalized in the ward and diagnosed with knee osteoarthritis according to ACR knee osteoarthritis criteria and had a Kellgren Lawrence staging of at least 2, were included.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Sayar, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065410
- Sponsor's protocol ID
- Gazi University PMR.
- Status last verified
- Oct 2023
- First submitted
- 8 Aug 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roos EM, Arden NK. Strategies for the prevention of knee osteoarthritis. Nat Rev Rheumatol. 2016 Feb;12(2):92-101. doi: 10.1038/nrrheum.2015.135. Epub 2015 Oct 6.
PubMed 26439406Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.
PubMed 29035179Turcot K, Armand S, Lubbeke A, Fritschy D, Hoffmeyer P, Suva D. Does knee alignment influence gait in patients with severe knee osteoarthritis? Clin Biomech (Bristol). 2013 Jan;28(1):34-9. doi: 10.1016/j.clinbiomech.2012.09.004. Epub 2012 Oct 12.
PubMed 23063098Neumann DL. A Systematic Review of Attentional Focus Strategies in Weightlifting. Front Sports Act Living. 2019 Aug 9;1:7. doi: 10.3389/fspor.2019.00007. eCollection 2019.
PubMed 33344931Johnson L, Burridge JH, Demain SH. Internal and external focus of attention during gait re-education: an observational study of physical therapist practice in stroke rehabilitation. Phys Ther. 2013 Jul;93(7):957-66. doi: 10.2522/ptj.20120300. Epub 2013 Apr 4.
PubMed 23559523Wulf G, Prinz W. Directing attention to movement effects enhances learning: a review. Psychon Bull Rev. 2001 Dec;8(4):648-60. doi: 10.3758/bf03196201.
PubMed 11848583Faisal AA, Selen LP, Wolpert DM. Noise in the nervous system. Nat Rev Neurosci. 2008 Apr;9(4):292-303. doi: 10.1038/nrn2258.
PubMed 18319728Muzet A. Environmental noise, sleep and health. Sleep Med Rev. 2007 Apr;11(2):135-42. doi: 10.1016/j.smrv.2006.09.001. Epub 2007 Feb 20.
PubMed 17317241Shidara M, Richmond BJ. Effect of visual noise on pattern recognition. Exp Brain Res. 2005 May;163(2):239-41. doi: 10.1007/s00221-005-2230-0. Epub 2005 Mar 15.
PubMed 15912370Helps SK, Bamford S, Sonuga-Barke EJ, Soderlund GB. Different effects of adding white noise on cognitive performance of sub-, normal and super-attentive school children. PLoS One. 2014 Nov 13;9(11):e112768. doi: 10.1371/journal.pone.0112768. eCollection 2014.
PubMed 25393410van Kempen E, van Kamp I, Lebret E, Lammers J, Emmen H, Stansfeld S. Neurobehavioral effects of transportation noise in primary schoolchildren: a cross-sectional study. Environ Health. 2010 Jun 1;9:25. doi: 10.1186/1476-069X-9-25.
PubMed 20515466
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Assistant Doctor
- ClinicalTrials.gov ID
- NCT06065410
- Acronym / sponsor ID
- Gazi University PMR.
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, white noise, intrinsic focusing, environmental sound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 3 Oct 2023 (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.
Patients with knee osteoarthritis may develop an antalgic gait over time due to pain in the knee, characterized by a decrease in the stance phase and stride length on the painful side. Gait asymmetry, which may lead to different musculoskeletal problems in the future, is observed in the patients. Gait symmetry can be achieved with gait retraining, and effective focus is required during training.
In the literature, there are many studies of the positive effects of white noise on focusing, but there are also studies that report that it reduces focusing.
Today, exercise training is usually performed in rehabilitation units or on treadmills. As there are important differences between walking on a treadmill and walking outdoors in terms of noise, uneven ground and visual stimuli, the place where walking training is performed does not reflect the outdoor environment.
It was aimed to investigate the effect of internal focusing on gait cycle and the effect of white noise and environmental sound on internal focusing in patients with knee osteoarthritis
Detailed description
A total of 40 patients between the ages of 50 and 75 years, who were admitted to the outpatient clinic of Gazi University Faculty of Medicine, Department of Physical Medicine and Rehabilitation or hospitalized in the ward and diagnosed with knee osteoarthritis according to ACR knee osteoarthritis criteria and had a Kellgren Lawrence staging of at least 2, were included.
The demographic data of the patients who were evaluated with the Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S) and had adequate hearing level were recorded, bilateral true leg lengths were measured and detailed knee examinations were performed. Lequesne Knee Osteoarthritis Severity Index, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lower Extremity Functional Scale (LEFS), 30 Second Sit to Stand Test and Timed Up and Go Test were applied to the patients who met the inclusion and exclusion criteria.
Patients walked at a speed of 0.40-0.45 m/s on a treadmill (Biodex Gait Trainer) where gait parameters were collected. Each patient walked at a constant speed for three minutes each in the baseline (without any instruction or sound), intrinsic focus (focusing on ensuring equal step lengths and step durations on both sides and symmetry between both steps), white noise (intrinsic focus accompanied by white noise) and environmental sound (intrinsic focus accompanied by environmental sound) conditions. After walking in each condition, gait parameters ( average step cycle, average step length, percentage of step length variability, percentage of left/right side stepping time and ambulation index) were recorded. The User Experience Questionnaire Short Form was adapted for our study to assess patients' experiences during intrinsically focused walking in white noise and environmental sound conditions. Patients were asked to rate their walking periods in white noise and environmental sound conditions in terms of inhibiting-supportive, inefficient-efficient, complex-simple, confusing-clear, boring-exciting, uninteresting-interesting, traditional-unique, and familiar-unusual characteristics.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Between the ages of 50 and 75 years, who were admitted to the outpatient clinic of Gazi University Faculty of Medicine, Department of Physical Medicine and Rehabilitation or hospitalized in the ward and diagnosed with knee osteoarthritis according to ACR knee osteoarthritis criteria and had a Kellgren Lawrence staging of at least 2, were included.
| Arm | Type | Receives |
|---|---|---|
| Patients with knee osteoarthritis | Experimental | Other: Baseline, Other: Intrinsic focus, Other: White noise, Other: environmental sound |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stable general condition
- Good cooperation
- Diagnosed with knee osteoarthritis according to ACR criteria
- At least stage 2 unilateral or bilateral knee osteoarthritis according to Kellgren Lawrence staging
- Individuals >50 years of age
Key exclusion criteria (4 listed)
- Hearing Impairment Scale ≥ 26
- Presence of a neurological, cardiac or orthopedic pathology that prevents walking
- The presence of another pathology other than knee osteoarthritis that affects the knee and causes pain
- Presence of diseases such as osteoarthritis, gout, rheumatoid arthritis affecting other joints in the lower extremity
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 |
|---|---|---|
| BaselineWalking without any instruction or sound | Other | Patients with knee osteoarthritis |
| Intrinsic focusWalking focusing on ensuring equal step lengths and step durations on both sides and symmetry between both steps | Other | Patients with knee osteoarthritis |
| White noiseIntrinsic focus accompanied by white noise | Other | Patients with knee osteoarthritis |
| environmental soundIntrinsic focus accompanied by environmental sound | Other | Patients with knee osteoarthritis |
Primary outcome
Average step cycle (cycle/second)
Time frame: Evaluation at first visit of patients meeting the included criteria.12 minutes in total, with 3 minutes of assessment time in each walking condition
After walking in each condition, average step cycle was recorded (total of 4 conditions)
Average step length (m)
Time frame: Evaluation at first visit of patients meeting the included criteria.12 minutes in total, with 3 minutes of assessment time in each walking condition
After walking in each condition, average step length was recorded (total of 4 conditions)
Percentage of step length variability (%)
Time frame: Evaluation at first visit of patients meeting the included criteria. 12 minutes in total, with 3 minutes of assessment time in each walking condition
After walking in each condition, percentage of step length variability was recorded (total of 4 conditions)
Percentage of left/right side stepping time (%)
Time frame: Evaluation at first visit of patients meeting the included criteria.12 minutes in total, with 3 minutes of assessment time in each walking condition
After walking in each condition, percentage of left/right side stepping time was recorded (total of 4 conditions)
Ambulation index
Time frame: Evaluation at first visit of patients meeting the included criteria.12 minutes in total, with 3 minutes of assessment time in each walking condition
After walking in each condition, ambulation index was recorded (total of 4 conditions)
1 secondary outcome
The User Experience Questionnaire Short Form
Time frame: Evaluation was performed immediately after execution in white noise and environmentel sound conditions
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 3 Oct 2023.
- Background: PubMed 26439406Roos EM, Arden NK. Strategies for the prevention of knee osteoarthritis. Nat Rev Rheumatol. 2016 Feb;12(2):92-101. doi: 10.1038/nrrheum.2015.135. Epub 2015 Oct 6.
- Background: PubMed 29035179Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.
- Background: PubMed 23063098Turcot K, Armand S, Lubbeke A, Fritschy D, Hoffmeyer P, Suva D. Does knee alignment influence gait in patients with severe knee osteoarthritis? Clin Biomech (Bristol). 2013 Jan;28(1):34-9. doi: 10.1016/j.clinbiomech.2012.09.004. Epub 2012 Oct 12.
- Background: PubMed 33344931Neumann DL. A Systematic Review of Attentional Focus Strategies in Weightlifting. Front Sports Act Living. 2019 Aug 9;1:7. doi: 10.3389/fspor.2019.00007. eCollection 2019.
- Background: PubMed 23559523Johnson L, Burridge JH, Demain SH. Internal and external focus of attention during gait re-education: an observational study of physical therapist practice in stroke rehabilitation. Phys Ther. 2013 Jul;93(7):957-66. doi: 10.2522/ptj.20120300. Epub 2013 Apr 4.
- Background: PubMed 11848583Wulf G, Prinz W. Directing attention to movement effects enhances learning: a review. Psychon Bull Rev. 2001 Dec;8(4):648-60. doi: 10.3758/bf03196201.
- Background: PubMed 18319728Faisal AA, Selen LP, Wolpert DM. Noise in the nervous system. Nat Rev Neurosci. 2008 Apr;9(4):292-303. doi: 10.1038/nrn2258.
- Background: PubMed 17317241Muzet A. Environmental noise, sleep and health. Sleep Med Rev. 2007 Apr;11(2):135-42. doi: 10.1016/j.smrv.2006.09.001. Epub 2007 Feb 20.
- Background: PubMed 15912370Shidara M, Richmond BJ. Effect of visual noise on pattern recognition. Exp Brain Res. 2005 May;163(2):239-41. doi: 10.1007/s00221-005-2230-0. Epub 2005 Mar 15.
- Background: PubMed 25393410Helps SK, Bamford S, Sonuga-Barke EJ, Soderlund GB. Different effects of adding white noise on cognitive performance of sub-, normal and super-attentive school children. PLoS One. 2014 Nov 13;9(11):e112768. doi: 10.1371/journal.pone.0112768. eCollection 2014.
- Background: PubMed 20515466van Kempen E, van Kamp I, Lebret E, Lammers J, Emmen H, Stansfeld S. Neurobehavioral effects of transportation noise in primary schoolchildren: a cross-sectional study. Environ Health. 2010 Jun 1;9:25. doi: 10.1186/1476-069X-9-25.
- 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?
A study testing Baseline, Intrinsic focus and White noise in people with Knee Osteoarthritis, run by Gazi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 3 Oct 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 Turkey (Türkiye). 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?
Average step cycle (cycle/second) (time frame: Evaluation at first visit of patients meeting the included criteria.12 minutes in total, with 3 minutes of assessment time in each walking condition). The study lists 5 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 NCT06065410, which also lists 11 linked publications.
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 3 Oct 2023.