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| ID | Type | Description | Link |
|---|---|---|---|
| Abdullah Al Assiri | Other Identifier | King Khalid University Medical City | |
| Prof Pip Logan | Other Identifier | Professor of Rehabilitation Research, University of Nottingham, UK. | |
| Professor Ana Valdes | Other Identifier | Professor of Molecular & Genetic Epidemiology, University of Nottingham, UK. | |
| Dr. Benjamin Smith | Other Identifier | Doctor of Physiotherapy, Division of Rehabilitation and Ageing, University of Nottingham. UK. |
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| Name | Class |
|---|---|
| University of Nottingham | OTHER |
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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:
The participants will be conducted over three phases:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility intervention | Experimental | The intervention will be foot insole (lateral wedge) insole, which has already been delivered in routine UK NHS and SA environments by at least one physiotherapist. Clinical testing will be done with 15-25 knee osteoarthritis subjects. These individuals will be assigned to a single intervention group for 4-6 weeks of re-gait training intervention. It involves a personalised gait retraining programme (sizable insole) for the KOA subjects to evaluate the impact on knee pain and improve function. It is set within 4-6 weeks of VAS and the WOMAC tools for knee pain & function outcome. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lateral Wedge insole | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level | 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). | 6 weeks post-intervention. |
| Western Ontario and McMaster Universities Arthritis Index-total | 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. | 6 weeks post-intervention. |
| Likert scale | Measuring knee osteoarthritic subjects' satisfaction based on the 5 point Likert scale survey. | 6 weeks post-intervention. |
| Likert scale | Measuring therapists' agreement based on the 5-point Likert scale survey. | 6 weeks post-intervention supervision. |
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Inclusion Criteria:
KOA Patient participants:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdullah Al Assiri, PhD student | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faisal Specialist Hospital & Research Centre | Jeddah | Western | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12086165 | Result | 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. | |
| 23723732 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 4, 2023 | Mar 7, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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).
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| Result | 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). |
| 22256414 | Result | Almalki M, Fitzgerald G, Clark M. Health care system in Saudi Arabia: an overview. East Mediterr Health J. 2011 Oct;17(10):784-93. doi: 10.26719/2011.17.10.784. |
| 12016084 | Result | Pollo FE, Otis JC, Backus SI, Warren RF, Wickiewicz TL. Reduction of medial compartment loads with valgus bracing of the osteoarthritic knee. Am J Sports Med. 2002 May-Jun;30(3):414-21. doi: 10.1177/03635465020300031801. |
| 17469197 | Result | 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. |
| 21656850 | Result | 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. |
| 22161816 | Result | 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. |
| 24054897 | Result | 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. |
| 22995151 | Result | 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. |
| D012216 |
| Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |