The Effect of Intrinsic Focus on Gait Cycle and the Possible Confounding Effect of Noise in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Research Assistant Doctor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06065410
• Other study ID #: Gazi University PMR.
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: October 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Baseline
Walking without any instruction or sound
• Intrinsic focus
Walking 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
• environmental sound
Intrinsic focus accompanied by environmental sound

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, Avon). 2013 Jan;28(1):34-9. doi: 10.1016/j.clinbiomech.2012.09.004. Epub 2012 Oct 12. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Evaluation was performed immediately after execution in white noise and environmentel sound conditions