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临床试验/NCT05847972
NCT05847972已完成不适用

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.

Fundación Universidad Católica de Valencia San Vicente Mártir2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Change from baseline dynamic degrees of ankle dorsiflexion at 12 weeks

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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).

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Individuals who have suffered a major injury in the previous two months.
  • FPI less than
  • 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

结局指标

主要结局

Change from baseline dynamic degrees of ankle dorsiflexion at 12 weeks

时间窗: 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

次要结局

  • Degrees of pronation in dynamics, measured with Runscribe (DP)(At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks))
  • 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))
  • Foot Function Index(At baseline; post 1 (inmmediate); post 2 (3weeks); post 3 (6weeks) and post 4 (12weeks))

研究者

发起方
Fundación Universidad Católica de Valencia San Vicente Mártir
申办方类型
Other
责任方
Sponsor

研究点 (2)

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