King Faisal Specialist Hospital & Research Centre
Jeddah, Western, Saudi Arabia
NCT Number: NCT06306079
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).
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Notify Me45 year and older
All sexes
Interventional
Not applicable
Jeddah, Western, Saudi Arabia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
KOA Patient participants:
Exclusion criteria
Insoles with lateral wedges are placed in patients' shoes to control biomechanical knee loading on the medial side of the knee. Insoles with lateral wedges are designed to be thinner on the inside (medially of the foot) and thicker on the outside (laterally of the foot) to relieve knee biomechanical loading parameters.
Other names: Footwear insole, Ankle foot orthoses
Time frame: 6 weeks post-intervention.
The change from baseline pain intensity level at 6-weeks, based on the nine points of a visual analogue scale, where 0 represents (no pain) and 9 represents (worst pain).
Time frame: 6 weeks post-intervention.
The change from baseline pain, stiffness and physical activity levels at 6-weeks.
Each question is scored from 0 to 4, which are: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Scores are summed for each subscale, ranging from 0-20 for pain, 0-8 for stiffness, and 0-68 for Physical Function.
A higher WOMAC score indicates worse pain, stiffness, and functional limitations.
Time frame: 6 weeks post-intervention.
Measuring knee osteoarthritic subjects' satisfaction based on the 5 point Likert scale survey.
Time frame: 6 weeks post-intervention supervision.
Measuring therapists' agreement based on the 5-point Likert scale survey.
King Khalid University
Other
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.
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