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.
Phase: NA
Conditions: Osteoarthritis, Knee, Pain, Biomechanical Lesion
Sponsor: King Khalid University

04/01/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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. 
 
ClinicalTrials.gov ID: [Not yet assigned] 
Last Update: 02/07/2023 

04/01/2023 
 
 
 
Study Identification 
 
Unique Protocol ID: KKUMC 
Brief Title: 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. 
Secondary IDs: Abdullah Al Assiri [King Khalid University Medical City] 
Prof Pip Logan [Professor of Rehabilitation Research, University of Nottingham, 
UK.] 
Professor Ana Valdes [Professor of Molecular & Genetic Epidemiology, 
University of Nottingham, UK.] 
Dr. Benjamin Smith [Doctor of Physiotherapy, Division of Rehabilitation and 
Ageing, University of Nottingham. UK.] 
Study Status 
 
Record Verification: January 2023 
Overall Status: Completed 
Study Start: April 13, 2022 [Actual] 
Primary Completion: October 15, 2022 [Actual] 
Study Completion: December 30, 2022 [Actual] 
Sponsor/Collaborators 
 
Sponsor: King Khalid University 
Responsible Party: Principal Investigator 
Investigator: Abdullah Al Assiri [aalassiri] 
Official Title: Principal Investigator 
Affiliation: King Khalid University 
Collaborators: University of Nottingham 
 
Oversight 
 
U.S. FDA-regulated Drug: No 
U.S. FDA-regulated Device: No 
U.S. FDA IND/IDE: No 
Human Subjects Review: Board Status: Approved 
Approval Number: FMHS 448-0122 
Board Name: Faculty of Medicine & Health Sciences Research Ethics 
Committee 
Board Affiliation: Medical School 
Phone: +44(0) 115 951 5151 
Email: FMHS-ResearchEthics@nottingham.ac.uk 
Address: 
Room E41, E Floor, Medical School 

March 5, 2024 
 
 
 
Queen’s Medical Centre Campus 
Nottingham University Hospitals 
Nottingham, NG7 2UH 
United Kingdome 
Data Monitoring: No 
FDA Regulated Intervention: No 
Study Description 
 
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 

March 5, 2024 
 
 
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. 
 
Conditions 
 
Conditions: Osteoarthritis, Knee 
Pain 
Biomechanical Lesion 
Keywords: Knee osteoarthritis 
Insole 
Biomechanical 
Saudi Arabia 
 
Study Design 
 
Study Type: Interventional 
Primary Purpose: Other 
Study Phase: N/A 
Interventional Study Model: Single Group Assignment 
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. 
Number of Arms: 1 
Masking: None (Open Label) 
Allocation: N/A 
Enrollment: 17 [Actual] 

March 5, 2024 
 
 
Arms and Interventions 
 
Arms 
Assigned Interventions 
Experimental: Feasibility intervention 
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. 
Device: Lateral Wedge insole 
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 
 
Outcome Measures 
Primary Outcome Measure: 
1. 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). 
[Time Frame: 6 weeks post-intervention.] 
2. 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. 
[Time Frame: 6 weeks post-intervention.] 
3. Likert scale 
Measuring knee osteoarthritic subjects’ satisfaction based on the 5 point Likert scale survey. 
[Time Frame: 6 weeks post-intervention.] 
4. Likert scale 
Measuring therapists’ agreement based on the 5-point Likert scale survey. 
[Time Frame: 6 weeks post-intervention supervision.] 
 
Eligibility 
 
Minimum Age: 45 Years 
Maximum Age: 
Sex: All 
Gender Based: 
Accepts Healthy Volunteers: No 
Criteria: Inclusion Criteria: 
KOA Patient participants: 
• Adults aged above 45 years old. 
• Both Male & Female. 

March 5, 2024 
 
 
• 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. 
 
Contacts/Locations 
 
Central Contact Person: Abdullah Al Assiri, PhD studnet 
Telephone: +966554900314 
Email: abdullah.alassiri@nottingham.ac.uk 
Central Contact Backup: 
Study Officials: Abdullah Al Assiri, PhD student 
Study Principal Investigator 
University of Nottingham 
Locations: Saudi Arabia 
King Faisal Specialist Hospital & Research Centre 
Jeddah, Western, Saudi Arabia 
Contact Waleed Bakallah, PT +966126677777 Ext. 61233 
: 
bakallah@kfshrc.edu.sa 
Principal Investigator: Abdullah Al Assiri, PhD student 
 
IPDSharing 
 
Plan to Share IPD: No 
 
References 
 
Citations: [Study Results] 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. PubMed 12086165 
[Study Results] 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. PubMed 23723732 

March 5, 2024 
 
 
 
[Study Results] 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). 
[Study Results] 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. PubMed 22256414 
[Study Results] 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. PubMed 12016084 
[Study Results] 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. PubMed 17469197 
[Study Results] 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. PubMed 21656850 
[Study Results] 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. PubMed 
22161816 
[Study Results] 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. PubMed 24054897 
[Study Results] 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. PubMed 22995151 
Links: 
Available IPD/Information: 
 
Documents 
Study Protocol 
Document Date: March 1, 2022 
Uploaded: 12/31/2022 10:21 
 
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