Clinical trial NCT05847972: Effect of Manual Therapy and Inmediately Application of Plantar Orthoses
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Injuries and Disorders
Keywords: ankle
plantar orthoses
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline dynamic degrees of ankle dorsiflexion at 12 weeks
timeFrame: At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks)
Secondary outcomes:
measure: Degrees of DF of the ankle in closed kinetic chain with the Lunge Test using LegMotion
timeFrame: At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks)
measure: Degrees of pronation in dynamics, measured with Runscribe (DP)
timeFrame: At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks)
measure: Foot Function Index
timeFrame: At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks)
Other outcomes:
Locations:
city: Torrent
country: Spain
facility: Juan Vicente-Mampel
state: Valencia
Study officials:
References: