Strengthening Program for Foot-ankle Muscles in People With Knee Osteoarthritis (NCT04154059) | Clinical Trial Compass
TerminatedNot Applicable
Strengthening Program for Foot-ankle Muscles in People With Knee Osteoarthritis
Stopped: The recruitment of potential participants is suspended due to the covid-19 pandemic.
Brazil30 participantsStarted 2020-01-27
Plain-language summary
The main objective of this trial is To evaluate the effect of an ankle and foot muscle strengthening program on pain, analgesic consumption, functionality, and lower limb biomechanics during gait in individuals with knee osteoarthritis.
Who can participate
Age range
40 Years – 75 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:
* Knee osteoarthritis (KOA) based on clinical and radiological criteria of American College of Reumathology;
* KOA (Grade II and III - Radiological classification of Kellgreen and Laurence) in medial compartment of knee;
* Knee pain between 30 and 80 on the visual analogue scale;
* BMI \< 35 kg/m2.
Exclusion Criteria:
* KOA isolated (Grade II and III - Radiological classification of Kellgreen and Laurence) in lateral compartment of knee;
* Lower limb strength training (3 times per week);
* Wear minimalist shoes for at least 6 hours a day and 5 days a week;
* Physical therapy in the previous 3 months;
* Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively;
* Previous history of surgery on knees, ankles and hips in the last 2 years;
* Neurological disease;
* Inflammatory arthritis (eg. rheumatoid arthritis);
* Asymptomatic OA of one or both knees.
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
1
Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks.