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NCT Number: NCT05847972

Effect of Manual Therapy and Inmediately Application of Plantar Orthoses

Limitation of ankle dorsiflexion is directly related to pronated foot. For its treatment, plantar orthoses and manual therapy are used. There is a lack of evidence on their combination, as to when the cast should be taken after manipulation. Our hypothesis proposes that it is more effective to cast immediately after manipulation.

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Key information

Conditions

Ankle Injuries and Disorders Ankle Injuries Disease Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juan Vicente-Mampel

Torrent, Valencia, 46900, Spain

About this study

The popularity of long-distance running has increased because it can be practised in many settings, the low cost and the links to prevention of health problems. In running between 19-79% of runners may suffer a running-related overuse injury each year. Pronated feet have been identified as a risk factor for lower limb overuse injury, and several studies have found that ankle dorsiflexion limitation is related to pronated feet.

There is a lack of evidence on their combination, as to when the cast should be taken after manipulation. Our hypothesis proposes that it is more effective to cast immediately after manipulation.

The main objective is to compare the effect of manipulation with motion (MWM) performed immediately prior to casting for plantar orthoses (PO) with the effect of manipulation with motion performed one week prior to casting for plantar orthoses on ankle dorsiflexion (ankle DF) and foot pronation in runners with hyper pronator feet secondary to a limited ankle DF.

This study's population will be composed by at least 16 individuals per group, both male and female, with ages among 18 and 45.

They will be randomised into two groups; group A, which will undergo MWM and have the moulds taken in phenolic foam immediately after the manipulation. The other group will be group B, which will undergo the MWM, and the moulds will be taken one week after the manipulation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Runners who run on asphalt.
  • Individuals who run at least >6 hours per week for 6 months prior to study participation.
  • Participants with hyperpronated feet secondary to ankle ROM limitation.
  • Runners with an ankle DF difference of >1.5cm in both feet or an ankle DF of less than 11.5cm according to the Lunge Test.

Exclusion criteria

  • Individuals who have suffered a major injury in the previous two months.
  • FPI less than 6.
  • Runners wearing minimalist footwear into which PO cannot be inserted.
  • Individuals already undergoing treatment with plantar supports.
  • Chronic widespread pain, including fibromyalgia.
  • Systemic rheumatic pathologies.
  • History of recent trauma or surgery

Treatment and study plan

MWM (Mobilization with movement)

Procedure

This manipulation is intended to improve ankle dorsiflexion. One session of 3 sets of 20 slow ankle dorsiflexion's separated by 10 seconds of rest will be performed.

Plantar Orthoses

Device

Procedure: MWM All participants will undergo MWM. This manipulation is intended to improve ankle dorsiflexion. One session of 3 sets of 20 slow ankle dorsiflexion's separated by 10 seconds of rest will be performed.

Procedure: Plantar orthoses The moulds will be taken immediately after the manipulation. The PO will be made of resin (0.8mm +1.2mm), 2mm hard EVA heel stabiliser, 3mm semi-hard EVA cover. The PO should be worn for 3 months to obtain the results of the study.

Primary outcomes

  1. Change from baseline dynamic degrees of ankle dorsiflexion at 12 weeks

    Time frame: At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks)

    Measured with Kinovea software. The patient will be recorded running in slow motion and the peroneal malleolus, the centre of the heel by the lateral edge and the head of the V metatarsal will be marked. It will then be analysed using Kinovea software

Secondary outcomes

  1. Degrees of DF of the ankle in closed kinetic chain with the Lunge Test using LegMotion

    Time frame: At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks)

    Lung Test will measure the distance between the toes and the Legmotion stirrup, which has been shown to have a moderate to excellent intra-rater reliability (ICC = 0.65-0.99) with a minimum detectable change of 1.9 cm and 4.7°.

  2. Degrees of pronation in dynamics, measured with Runscribe (DP)

    Time frame: At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks)

    Runsribe sensors will be placed on the runners while they run. Data will be recorded with the official Runscribe App. This method is validated by Lewin et al.

  3. Foot Function Index

    Time frame: At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks)

    FFI for the assessment of pain, disability and limitation of foot function, recommended for use in both clinical and research settings.

Sponsors and collaborators

Lead sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Other

Registry information

Official study title

Evaluation of the Effect of Manual Therapy and the Application of Plantar Orthoses in Amateur Runners With Ankle Range of Motion Restriction. A Randomised Clinical Trial.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 8, 2023
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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