NCT06065410

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

August 8, 2023

Last Update Submit

October 2, 2023

Conditions

Keywords

knee osteoarthritiswhite noiseintrinsic focusingenvironmental sound

Outcome Measures

Primary Outcomes (5)

  • Average step cycle (cycle/second)

    After walking in each condition, average step cycle was recorded (total of 4 conditions)

    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)

    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)

    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)

    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)

    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

    Evaluation was performed immediately after execution in white noise and environmentel sound conditions

Study Arms (1)

Patients with knee osteoarthritis

EXPERIMENTAL
Other: BaselineOther: Intrinsic focusOther: White noiseOther: environmental sound

Interventions

Walking without any instruction or sound

Patients with knee osteoarthritis

Walking focusing on ensuring equal step lengths and step durations on both sides and symmetry between both steps

Patients with knee osteoarthritis

Intrinsic focus accompanied by white noise

Patients with knee osteoarthritis

Intrinsic focus accompanied by environmental sound

Patients with knee osteoarthritis

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Medicine

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

    PMID: 26439406BACKGROUND
  • Lespasio 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.

    PMID: 29035179BACKGROUND
  • Turcot 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.

    PMID: 23063098BACKGROUND
  • Neumann 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.

    PMID: 33344931BACKGROUND
  • Johnson 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.

    PMID: 23559523BACKGROUND
  • Wulf 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.

    PMID: 11848583BACKGROUND
  • Faisal AA, Selen LP, Wolpert DM. Noise in the nervous system. Nat Rev Neurosci. 2008 Apr;9(4):292-303. doi: 10.1038/nrn2258.

    PMID: 18319728BACKGROUND
  • Muzet 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.

    PMID: 17317241BACKGROUND
  • Shidara 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.

    PMID: 15912370BACKGROUND
  • Helps 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.

    PMID: 25393410BACKGROUND
  • van 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.

    PMID: 20515466BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Medical Doctor

Study Record Dates

First Submitted

August 8, 2023

First Posted

October 3, 2023

Study Start

February 1, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

October 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations