CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
Lateral Wedge insoledevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06306079
NCT06306079N/ACompleted

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.

King Khalid University·interventional·Posted Mar 12, 2024·Updated Mar 12, 2024

In Brief

A clinical study evaluating Lateral Wedge insole for Osteoarthritis, Knee and 2 related conditions. Completed, enrolled 17 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSaudi Arabia

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 12, 2024
Enrollment StartApr 13, 2022
Primary CompletionOct 15, 2022
Study CompletionDec 30, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.3 years ago

Interventions

Lateral Wedge insoledevice

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.