protocolSection identificationModule nctId: NCT06306079, orgStudyIdInfo id: KKUMC, secondaryIdInfos id: Abdullah Al Assiri, type: OTHER, domain: King Khalid University Medical City, secondaryIdInfos id: Prof Pip Logan, type: OTHER, domain: Professor of Rehabilitation Research, University of Nottingham, UK., secondaryIdInfos id: Professor Ana Valdes, type: OTHER, domain: Professor of Molecular & Genetic Epidemiology, University of Nottingham, UK., secondaryIdInfos id: Dr. Benjamin Smith, type: OTHER, domain: Doctor of Physiotherapy, Division of Rehabilitation and Ageing, University of Nottingham. UK., briefTitle: Using Gait Modification to Treat Knee Osteoarthritis in Saudi Arabia: Possibilities and Acceptability., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-13, primaryCompletionDateStruct date: 2022-10-15, completionDateStruct date: 2022-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: King Khalid University, class: OTHER, collaborators name: University of Nottingham, descriptionModule briefSummary: A variety of biomechanical gait modification interventions can elevate knee loading and improve knee symptoms in knee osteoarthritis patients. However, there was a lack of acceptability and adherence regarding modification interventions without any explanation.Thus, this study investigates the feasibility and acceptability of foot insoles as a gait modification tool among Saudi Arabian knee osteoarthritis patients and physiotherapists.This study aims to answer the following:* Which gait modification intervention is most likely to be implemented in Saudi Arabia (SA) clinical practice, taking context, patients' clinical and research evidence into consideration?* In Saudi Arabia, can this proposed foot-insole intervention be implemented? Is there sufficient experience among physiotherapists regarding gait modification to deliver it, and will patients engage with it? How can KOA rehabilitation outcomes be evaluated in the future?The participants will be conducted over three phases:1. The patients' interview and therapists' focus group discussion will be used to examine KOA patients' and clinicians' perspectives on enabling and accepting gait modifications in phase 1.2. The feasibility study will explore how a small number of KOA patients tolerate gait modifications and consider the most relevant outcome measures, such as pain and function, in phase (2).3. A small group of knee osteoarthritis patients and their physiotherapists who participated in phase (2) will be asked to participate in a descriptive survey in phase (3). To examine the acceptability and feasibility of the study intervention in phase (2)., conditionsModule conditions: Osteoarthritis, Knee, conditions: Pain, conditions: Biomechanical Lesion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A gait modification (Lateral wedge insole) program will be conducted over 4 to 6 weeks in the physiotherapy gym or adjusted treadmill and outside the clinic during the day (at least 8 hours per day).* During the session, the researcher will observe participants inside the clinic and ensure that the modified gait application is applied, and outside the clinic will be followed by telephone.* Participants will walk on the gym floor or an adjusted treadmill for at least 15 to 20 minutes during each session. Participants will be instructed to use the mirror for feedback and achieve the target modified gait procedure. However, it will be emphasised gait modification procedures exhibited at baseline pain and function, and then at the end of the trial, it will focus on subjects' acceptability., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 17, type: ACTUAL, armsInterventionsModule interventions name: Lateral Wedge insole, outcomesModule primaryOutcomes measure: Pain level, primaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index-total, primaryOutcomes measure: Likert scale, primaryOutcomes measure: Likert scale, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King Faisal Specialist Hospital & Research Centre, city: Jeddah, state: Western, country: Saudi Arabia, geoPoint lat: 21.54238, lon: 39.19797, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-01-04, uploadDate: 2024-03-07T05:51, filename: Prot_000.pdf, size: 234397, hasResults: False