CompletedNot Applicable

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

Saudi Arabia17 participantsStarted 2022-04-13

Plain-language 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).

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain level

Timeframe: 6 weeks post-intervention.

Western Ontario and McMaster Universities Arthritis Index-total

Timeframe: 6 weeks post-intervention.

Likert scale

Timeframe: 6 weeks post-intervention.

Likert scale

Timeframe: 6 weeks post-intervention supervision.

Trial details

NCT IDNCT06306079

SponsorKing Khalid University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-15

View on ClinicalTrials.gov More Osteoarthritis, Knee trials

Plain-language summary

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.