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

March 7, 2024 updated by: Abdullah Al Assiri, King Khalid University

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Western
      • Jeddah, Western, Saudi Arabia
        • King Faisal Specialist Hospital & Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
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).
6 weeks post-intervention.
Western Ontario and McMaster Universities Arthritis Index-total
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.
6 weeks post-intervention.
Likert scale
Time Frame: 6 weeks post-intervention.
Measuring knee osteoarthritic subjects' satisfaction based on the 5 point Likert scale survey.
6 weeks post-intervention.
Likert scale
Time Frame: 6 weeks post-intervention supervision.
Measuring therapists' agreement based on the 5-point Likert scale survey.
6 weeks post-intervention supervision.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Khalid University

Collaborators

University of Nottingham

Investigators

  • Principal Investigator: Abdullah Al Assiri, PhD student, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2022

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

December 31, 2022

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKUMC
  • 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.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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