Effect of Manual Therapy and Inmediately Application of Plantar Orthoses

NCT05847972 | Completed DMC

• 1 other identifier: UCV/2022-2023/093
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Injuries and Disorders

Keywords

ankle; plantar orthoses

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (3)

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

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

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

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

• Foot Function Index

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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Procedure: MWM (Mobilization with movement); Device: Plantar orthoses

Control Group

PLACEBO COMPARATOR

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

Procedure: MWM (Mobilization with movement); Device: Plantar orthoses

Interventions

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.

Control Group; Experimental Group

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.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (1)

Juan Vicente-Mampel

Torrent, Valencia, 46900, Spain

Location

MeSH Terms

Conditions

Ankle Injuries; Disease

Interventions

Movement

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 8, 2023
• Study Start: June 6, 2023
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)