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Effect of Manual Therapy and Inmediately Application of Plantar Orthoses

Primary Purpose

Ankle Injuries and Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MWM (Mobilization with movement)
Plantar orthoses
Sponsored by
Fundación Universidad Católica de Valencia San Vicente Mártir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries and Disorders focused on measuring ankle, plantar orthoses

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental Group

    Control Group

    Arm Description

    A will undergo MWM and have their moulds taken in phenolic foam immediately after the musculoskeletal manipulation.

    Participants will undergo MWM and moulds will be taken one week after the musculoskeletal manipulation.

    Outcomes

    Primary Outcome Measures

    Change from baseline dynamic degrees of ankle dorsiflexion at 12 weeks
    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

    Degrees of DF of the ankle in closed kinetic chain with the Lunge Test using LegMotion
    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°.
    Degrees of pronation in dynamics, measured with Runscribe (DP)
    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.
    Foot Function Index
    FFI for the assessment of pain, disability and limitation of foot function, recommended for use in both clinical and research settings.

    Full Information

    First Posted
    April 5, 2023
    Last Updated
    May 4, 2023
    Sponsor
    Fundación Universidad Católica de Valencia San Vicente Mártir
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05847972
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2023 (Anticipated)
    Primary Completion Date
    May 20, 2023 (Anticipated)
    Study Completion Date
    September 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundación Universidad Católica de Valencia San Vicente Mártir

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankle Injuries and Disorders
    Keywords
    ankle, plantar orthoses

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    The groups will be arranged randomly and the masking technique to be used will the single blind procedure. The random allocation to each group will be made just by the software Epidat version 4.2 of the Galician Health Service (link: https://www.sergas.es/Saude-publica/EPIDAT?idioma=es).
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    A will undergo MWM and have their moulds taken in phenolic foam immediately after the musculoskeletal manipulation.
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will undergo MWM and moulds will be taken one week after the musculoskeletal manipulation.
    Intervention Type
    Procedure
    Intervention Name(s)
    MWM (Mobilization with movement)
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Plantar orthoses
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change from baseline dynamic degrees of ankle dorsiflexion at 12 weeks
    Description
    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
    Time Frame
    At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks)
    Secondary Outcome Measure Information:
    Title
    Degrees of DF of the ankle in closed kinetic chain with the Lunge Test using LegMotion
    Description
    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°.
    Time Frame
    At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks)
    Title
    Degrees of pronation in dynamics, measured with Runscribe (DP)
    Description
    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.
    Time Frame
    At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks)
    Title
    Foot Function Index
    Description
    FFI for the assessment of pain, disability and limitation of foot function, recommended for use in both clinical and research settings.
    Time Frame
    At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    María Jesús Ramos Vera, PDI
    Phone
    615100520
    Email
    mariajesus.rv@mail.ucv.es

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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