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Effect of Manual Therapy and Inmediately Application of Plantar Orthoses

Not Applicable
Completed
Conditions
Ankle Injuries and Disorders
Interventions
Procedure: MWM (Mobilization with movement)
Device: Plantar orthoses
Registration Number
NCT05847972
Lead Sponsor
Fundación Universidad Católica de Valencia San Vicente Mártir
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control GroupMWM (Mobilization with movement)Participants will undergo MWM and moulds will be taken one week after the musculoskeletal manipulation.
Experimental GroupMWM (Mobilization with movement)A will undergo MWM and have their moulds taken in phenolic foam immediately after the musculoskeletal manipulation.
Experimental GroupPlantar orthosesA will undergo MWM and have their moulds taken in phenolic foam immediately after the musculoskeletal manipulation.
Control GroupPlantar orthosesParticipants will undergo MWM and moulds will be taken one week after the musculoskeletal manipulation.
Primary Outcome Measures
NameTimeMethod
Change from baseline dynamic degrees of ankle dorsiflexion at 12 weeksAt 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 Outcome Measures
NameTimeMethod
Degrees of pronation in dynamics, measured with Runscribe (DP)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.

Degrees of DF of the ankle in closed kinetic chain with the Lunge Test using LegMotionAt 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°.

Foot Function IndexAt 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.

Trial Locations

Locations (1)

Juan Vicente-Mampel

🇪🇸

Torrent, Valencia, Spain

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