Clinical trial NCT06306079: Using Gait Modification to Treat Knee Osteoarthritis in Saudi Arabia: Possibilities and Acceptability.
Official title: The Possibilities and Acceptability of Applying Gait Modification to the Treatment of Knee Osteoarthritis in Saudi Arabia Based on the Perceptions of Patients and Physiotherapists. A Mixed-methods Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Pain
Biomechanical Lesion
Keywords: Knee osteoarthritis
Insole
Biomechanical
Saudi Arabia
Lead sponsor: King Khalid University
Sponsor class: OTHER
Collaborators: name: University of Nottingham
First posted: 2024-03-12
Enrollment: 17
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: 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).

Detailed description: Since several different types of gait modifications have been studied, it has been challenging to determine which are most likely to be used by patients and healthcare professionals.

A notable number of Saudi Arabians suffer from knee osteoarthritis (KOA), which reported a 29.5% prevalence of KOA; another recent study reported a 24.5% prevalence of KOA among the elderly. A 2002 study found that 30.8% of those aged 46-55 and 60.6% aged 66-75 were affected. Thus, KOA is roughly equally distributed between genders and is more prevalent among elderly and overweight individuals, so policymakers should focus on raising awareness to prevent and treat affected individuals. The healthcare system in SA is publicly funded and accessible; 79% of patients use the public system, and the rest obtain private care. In most cases, private patients have insurance coverage. The public healthcare system has three primary, secondary, and tertiary care levels. Rehabilitation and gait modification investigations are not available at the primary level.

This snapshot of the literary review raises questions about the viability of the long-term use of learned/assistive gait modifications. The studies reported dissatisfaction with the gait modification approach but gave no reasons. Since most studies focus on results in a short time or a specific area, pre-training courses measuring acceptability and commitment can fill the gaps in previous studies. After determining the importance of gait modification, the question becomes, should it be integrated into the therapy strategy or other rehabilitative methods to increase the treatment's clinical efficacy? It is essential to understand the practices, views and expectations of KOA patients and health professionals concerning gait modifications.

Eligibility criteria: Inclusion Criteria:

KOA Patient participants:

* Adults aged above 45 years old.
* Both Male \& Female.
* Radiographically or KOA participants meet any diagnostic classification guidelines/criteria (American College of Rheumatology classification criteria) or any eligible diagnostic guidelines.
* Typical knee pain while walking \> 3 on an 11-point scale (0-10) in at least one knee pain or tenderness, primarily in the medial knee.

Exclusion Criteria:

* Severe KOA subjects (on the waiting list for knee arthroplasty).
* Knee post-operation or corticosteroid intra-articular injection last 6 months.
* Inability to walk for longer than 20 minutes without experiencing severe pain.
* Painful treadmill walking or unable to walk without heavy assistance, such as a lifting belt or walker frame.
* Significant knee effusion, musculoskeletal or neurological diseases that influence gait parameters.
* It is presently undergoing physiotherapy treatment.
* Rheumatoid Arthritis (RA), gout, one or both knees replaced, low back pain, hip OA, any serious knee or lower limb injuries in the past 24 months.

Primary outcomes:
measure: Pain level
timeFrame: 6 weeks post-intervention.
measure: Western Ontario and McMaster Universities Arthritis Index-total
timeFrame: 6 weeks post-intervention.
measure: Likert scale
timeFrame: 6 weeks post-intervention.
measure: Likert scale
timeFrame: 6 weeks post-intervention supervision.
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre
state: Western
Study officials:
affiliation: University of Nottingham
name: Abdullah Al Assiri, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Arfaj A, Al-Boukai AA. Prevalence of radiographic knee osteoarthritis in Saudi Arabia. Clin Rheumatol. 2002 May;21(2):142-5. doi: 10.1007/s10067-002-8273-8.
citation: Al-Modeer MA, Hassanien NS, Jabloun CM. Profile of morbidity among elderly at home health care service in Southern Saudi Arabia. J Family Community Med. 2013 Jan;20(1):53-7. doi: 10.4103/2230-8229.108187.
citation: Khalid W. AlKuwaity, Tasneem N. Mohammad, Malik A. Hussain, Annas Alkhanani, A. M. . A. (2018) 'Prevalence and Determinant Factors of Osteoarthritis of the Knee Joint among Elderly in Arar, KSA', The Egyptian Journal of Hospital Medicine, 72(9).
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citation: Butler RJ, Marchesi S, Royer T, Davis IS. The effect of a subject-specific amount of lateral wedge on knee mechanics in patients with medial knee osteoarthritis. J Orthop Res. 2007 Sep;25(9):1121-7. doi: 10.1002/jor.20423.
citation: Kutzner I, Damm P, Heinlein B, Dymke J, Graichen F, Bergmann G. The effect of laterally wedged shoes on the loading of the medial knee compartment-in vivo measurements with instrumented knee implants. J Orthop Res. 2011 Dec;29(12):1910-5. doi: 10.1002/jor.21477. Epub 2011 Jun 8.
citation: Fantini Pagani CH, Hinrichs M, Bruggemann GP. Kinetic and kinematic changes with the use of valgus knee brace and lateral wedge insoles in patients with medial knee osteoarthritis. J Orthop Res. 2012 Jul;30(7):1125-32. doi: 10.1002/jor.22032. Epub 2011 Dec 12.
citation: Jones RK, Zhang M, Laxton P, Findlow AH, Liu A. The biomechanical effects of a new design of lateral wedge insole on the knee and ankle during walking. Hum Mov Sci. 2013 Aug;32(4):596-604. doi: 10.1016/j.humov.2012.12.012. Epub 2013 Jul 17.
citation: Moyer RF, Birmingham TB, Dombroski CE, Walsh RF, Leitch KM, Jenkyn TR, Giffin JR. Combined effects of a valgus knee brace and lateral wedge foot orthotic on the external knee adduction moment in patients with varus gonarthrosis. Arch Phys Med Rehabil. 2013 Jan;94(1):103-12. doi: 10.1016/j.apmr.2012.09.004. Epub 2012 Sep 17.