The Effect of Foot Core Exercises or Foot Orthotics in Symptomatic Flexible Flatfoot (NCT05840965) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Foot Core Exercises or Foot Orthotics in Symptomatic Flexible Flatfoot
Belgium48 participantsStarted 2023-06-01
Plain-language summary
The overall goal of this study is to evaluate the effect of a foot strengthening program (focused on the intrinsic foot muscles) on ankle and foot joint kinematics and kinetics (rearfoot, midfoot, and forefoot) in patients with symptomatic flexible flat feet. The investigators will also evaluate the effect on intrinsic muscle morphology, foot strength, pain and other symptoms. The investigators will compare to the standard conservative therapy, which is foot orthotic therapy.
Who can participate
Age range
18 Years – 65 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:
For both asymptomatic and symptomatic flexible flatfoot:
* Adults between 18 and 65 years of age, able to run at a self- selected low speed.
* Physically active: min. 1h30 and max 6 h/week
* Foot Posture Index \> 6 AND Navicular drop \> 5 mm
* Informed consent (ICF) obtained
For asymptomatic flexible flatfoot:
cfr. supra
For symptomatic flexible flatfoot:
* Diagnosis made by a physician
* ICF obtained
* Symptomatic =
* Foot pain ( \> 4 on Visual Analog Pain Scale score) OR
* Medial arch pain OR
* Metatarsalgia (general or diffuse hyperkeratosis accepted) OR
* Lateral impingement pain OR
* Sinus tarsi pain OR
* Tibialis posterior dysfunction stage I and II (without indication of rupture) and painful single heel raise test
Exclusion Criteria:
For both groups:
* \< 18 years, \> 65 years
* Any medical contraindication to physical exertion
* Systemic diseases
* Recent lower limb surgery (\< 6 months)
* Lower limb osteosynthesis material
* Pregnancy
* Pacemaker
* Leg length discrepancy \> 3 cm
* Body Mass Index (BMI) \> 30kg/m²
* Constant ankle pain
* Ankle fractures
* Single hyperkeratotic lesion with nucleus under metatarsal head
* Recent participation in a physical rehabilitation program (\< 3 months)
* Recent orthotics (\< 3 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
1
Change in lower limb joint angles (degrees)
Timeframe: 8-week intervention period
2
Change in lower limb joint angular velocities (degrees/second)