UnknownNot Applicable

Clinical Effects of the Medial Longitudinal Arch Slope of a Plantar Orthosis

74 participantsStarted 2024-06-20

Plain-language summary

The objective of this clinical trial is to compare the effects of the geometry of the medial longitudinal arch (MLA) of the insole on acceleration impacts during gait, measured using an accelerometry system, in patients with pain related to the presence of a pronated foot morphotype. The main questions it aims to answer are: Is the slope of the medial longitudinal arch of the orthotic treatment a factor that reduces the peak tibial accelerometry in a symptomatic foot with a medially oriented subtalar joint axis? To assess the predictive effect of changes in acceleration impacts on the patient's painful symptoms. The researchers will compare the MLA of the insole taken in a standing position with the MLA of the insole taken in a sitting position (the treatment applied in routine clinical practice) to evaluate if changing the slope of the MLA generates changes in the tibial acceleration impacts. The participants: Must use the insoles to carry out their daily activities, except for sleeping or bathing. The first review of the orthotic treatment will be conducted 3 months after the treatment initiation.

Who can participate

Age range

18 Years – 80 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: Subjects of both sexes, aged over 18 years. Patients with painful symptoms in the lower limb associated with a Foot Posture Index (FPI-6) score \> 5, indicative of foot pronation position. Navicular Drop Test \> 10 mm. Subjects with painful symptoms associated with foot pronation position. Signed informed consent explaining the study's characteristics and objectives. Exclusion Criteria: Subjects presenting at least one of the following conditions will be excluded: Previous diagnosis of neurological or rheumatological systemic disease. History of foot or ankle surgery resulting in limitations in the mobility of the subtalar, midtarsal, or metatarsophalangeal joints. History of leg, ankle, or foot fracture resulting in limitations in the mobility of these structures. Lower limb morpho-functional alteration: clinical asymmetry greater than 5 mm, presence of genu varum, genu valgum with a difference of more than 2° femoro-tibial between limbs, internal or external femoral torsion. Cognitive impairment preventing understanding of the study's objectives and compliance with participation guidelines. Patients unable to walk independently due to musculoskeletal injury in the lower limbs within the last 6 months. Currently receiving any analgesic treatment for the lower limbs at the time of intervention.

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

Maximum tibial acceleration (g).

Timeframe: The maximum tibial acceleration (g) is measured during the 2nd visit when we initiate orthopedic treatment and during the 3rd visit, after 3 months of using the plantar orthosis, using a triaxial accelerometry system.

Trial details

NCT IDNCT06474585

SponsorUniversidad Complutense de Madrid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-01

View on ClinicalTrials.gov More Pronated Left Foot trials