Using Gait Modification to Treat Knee Osteoarthritis in Saudi Arabia: Possibilities and Acceptability.

NCT06306079 | Completed

• 5 other identifiers: KKUMCAbdullah Al AssiriProf Pip LoganProfessor Ana ValdesDr. Benjamin Smith
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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:
• 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.
• 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).
• 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).

Conditions

Osteoarthritis, Knee; Pain; Biomechanical Lesion

Keywords

Knee osteoarthritis; Insole; Biomechanical; Saudi Arabia

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (1)

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.

Device: Lateral Wedge insole

Interventions

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.

Also known as: Footwear insole, Ankle foot orthoses

Feasibility intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Khalid University: lead
• University of Nottingham: collaborator

Study Sites (1)

King Faisal Specialist Hospital & Research Centre

Jeddah, Western, Saudi Arabia

Location

Related Publications (10)

• 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.

  PMID: 12086165 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.

  PMID: 23723732 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).

  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.

  PMID: 22256414 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.

  PMID: 12016084 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.

  PMID: 17469197 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.

  PMID: 21656850 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.

  PMID: 22161816 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.

  PMID: 24054897 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.

  PMID: 22995151 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdullah Al Assiri, PhD student

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 31, 2022
• First Posted: March 12, 2024
• Study Start: April 13, 2022
• Primary Completion: October 15, 2022
• Study Completion: December 30, 2022
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)