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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Baseline
Intrinsic focus
White noise
environmental sound
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, white noise, intrinsic focusing, environmental sound

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gazi University Faculty of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with knee osteoarthritis

Arm Description

Outcomes

Primary Outcome Measures

Average step cycle (cycle/second)
After walking in each condition, average step cycle was recorded (total of 4 conditions)
Average step length (m)
After walking in each condition, average step length was recorded (total of 4 conditions)
Percentage of step length variability (%)
After walking in each condition, percentage of step length variability was recorded (total of 4 conditions)
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)
Ambulation index
After walking in each condition, ambulation index was recorded (total of 4 conditions)

Secondary Outcome Measures

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.

Full Information

First Posted
August 8, 2023
Last Updated
October 2, 2023
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT06065410
Brief Title
The Effect of Intrinsic Focus on Gait Cycle and the Possible Confounding Effect of Noise in Patients With Knee Osteoarthritis
Official Title
Research Assistant Doctor
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, white noise, intrinsic focusing, environmental sound

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with knee osteoarthritis
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Baseline
Intervention Description
Walking without any instruction or sound
Intervention Type
Other
Intervention Name(s)
Intrinsic focus
Intervention Description
Walking focusing on ensuring equal step lengths and step durations on both sides and symmetry between both steps
Intervention Type
Other
Intervention Name(s)
White noise
Intervention Description
Intrinsic focus accompanied by white noise
Intervention Type
Other
Intervention Name(s)
environmental sound
Intervention Description
Intrinsic focus accompanied by environmental sound
Primary Outcome Measure Information:
Title
Average step cycle (cycle/second)
Description
After walking in each condition, average step cycle was recorded (total of 4 conditions)
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
Title
Average step length (m)
Description
After walking in each condition, average step length was recorded (total of 4 conditions)
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
Title
Percentage of step length variability (%)
Description
After walking in each condition, percentage of step length variability was recorded (total of 4 conditions)
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
Title
Percentage of left/right side stepping time (%)
Description
After walking in each condition, percentage of left/right side stepping time was recorded (total of 4 conditions)
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
Title
Ambulation index
Description
After walking in each condition, ambulation index was recorded (total of 4 conditions)
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
Secondary Outcome Measure Information:
Title
The User Experience Questionnaire Short Form
Description
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.
Time Frame
Evaluation was performed immediately after execution in white noise and environmentel sound conditions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gazi University Faculty of Medicine
City
Ankara
ZIP/Postal Code
06560
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26439406
Citation
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Citation
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Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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The Effect of Intrinsic Focus on Gait Cycle and the Possible Confounding Effect of Noise in Patients With Knee Osteoarthritis

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