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临床试验/NCT03423498
NCT03423498已完成不适用

The Possibility of the Activation of the Abductor Hallucis Muscle as a Result of the Toe-spread-out Exercise in Patients With Hallux Valgus and in People Without the Deformity: Clinical Trial.

Poznan University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2015年10月20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
51
试验地点
2
主要终点
Evaluation of changes in amplitude of motor unit action potential (MUAP)

研究概览

简要总结

The effectiveness of conservative treatment of hallux valgus deformity has not been sufficiently explored yet. The aim of this study was to assess the effect of the toe-spread-out exercise on the amplitude and frequency pattern in a surface electromyographic examination in patients with hallux valgus and in people without the deformity. An additional objective is the assessment of nerve conduction in an electroneurography and the assessment of range of motion in a clinical examination.

详细描述

The study design was based on an interventional model (clinical trial). The participants were assigned to two research groups (A - with diagnosis of hallux valgus and B- without the deformity) that received therapeutic intervention of the TSO exercise performed unilaterally. The unexercised feet could have caused a synergistic effect and falsified the results, thus the unexercised feet were excluded from the control group. Nevertheless, a small control group which did not undergo any hallux therapy was created to check if any changes in analysed parameters are actually related to the intervention. These control group patients were examined twice at an interval of 14 days.

The hallux deformities were assessed on the basis of X-ray images taken in weight-bearing conditions, in a standing position in the anterior-posterior projection. On all X-rays the hallux valgus angles (HVA) and the first intermetatarsal angles (FIA) were designated and measured by one radiologist.

Additionally, each patient with hallux valgus was assessed according to the Hallux Metatarsophalangeal-Interphalangeal scale (HMP-IP scale) developed by the AOFAS (American Orthopaedic Foot and Ankle Society).

The effects of the exercises were assessed using a comparison of the outcomes of two examinations: before and after therapy (research group A and B). For this purpose, a surface electromyographic examination (sEMG) recorded from the abductor hallucis (AbdH) muscle was performed. The following parameters of electromyography were analysed in three phases of TSO exercise: amplitude and frequency pattern. Additionally, the motor fibres of the tibial nerve and the sensory fibres of the sural nerve function in electroneurographic examination (ENG) and range of motion of hallux using goniometer were assessed.

The sEMG recorded from the AbdH muscle and the ENG were performed with the use of the KeyPoint System (Medtronic A/S, Skovlunde, Denmark) and appropriate to the type of neurophysiological studies and set of electrodes (surface electrodes, bipolar stimulating electrode, and grounding electrode).

研究设计

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

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for patients with hallux valgus (research group A and control group): "B", "C" or "D" score in the Manchester scale, hallux valgus angle above 15° • for healthy volunteers (research group B) "A" score in the Manchester scale, hallux valgus angle equal or lower than 15°

排除标准

  • for all groups: a serious injury or a history of lower limb surgery, presence of pain from a disc disease on the background of the disco-radicular conflict (based on the ENG study), neuropathy, myopathy, rheumatoid arthritis, psoriatic arthritis, connective tissue diseases, a history of strokes or other neurological diseases.

结局指标

主要结局

Evaluation of changes in amplitude of motor unit action potential (MUAP)

时间窗: 2 weeks (14 days)

The amplitude of motor unit action potential (MUAP) recorded from the abductor hallucis muscle in three phases of exercise and measured in mV

次要结局

  • Evaluation of changes in frequency pattern of abductor hallucis muscle activity(2 weeks (14 days))

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Małgorzata Eliks

Assistant, MSc

Poznan University of Medical Sciences

研究点 (2)

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