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临床试验/NCT04507490
NCT04507490Unknown不适用

Acute Effect of Whole Body Vibration of Different Frequencies on Balance and Functional Mobility of Patients With Parkinson: Crossover-type Controlled Clinical Trial

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年8月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
12
试验地点
2
主要终点
Change in Function mobility

研究概览

简要总结

Parkinson's disease has innumerous motor symptoms that impacting on the functional level of the patient, such as impairment in functional mobility and balance . Previous studies have already aimed to evaluate the effectiveness of whole body vibration, but without methodological criteria. The use of whole body vibration may be an alternative for the treatment of Parkinson's disease. Therefore, the objective of the study is to verify which frequency of vibration is able to improve the balance and mobility of patients with Parkinson's disease.

详细描述

After confirming the eligibility criteria, patients will be asked to sign the informed consent form. Subsequently, they will be randomly allocated to three groups: (i) group 6 Hz: full body vibration (frequency 6 Hz, amplitude 4 mm, five cycles lasting 1 minutes and interval between cycles of 1 minute) , (ii) 25 Hz group: full body vibration (25 Hz frequency, 4 mm amplitude, five cycles lasting 1 minute and interval between 1 minute cycles) and (iii) sham group: The sham vibration will be performed with the platform disconnected. Additionally, a sound device will be connected producing a noise similar to that of the connected platform for a time equivalent to that of the treatment protocol. The patient will be instructed to position himself standing on the platform, with a semi knee flexion in order that the vibration wave does not propagate to the head. The allocation will be made randomly among individuals, using a random sequence table generated by the website www.randomization.com. There will be a washout time of at least one week between one intervention and another. All evaluations took place inside the laboratory, which has all the equipment for the evaluation. The evaluations will take place immediately before the intervention and immediately after.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Double blind. Only the interventionist will be allowed to access the vibration condition. In this way, the patient and the investigator will be blind for the type of vibration that the patient will receive.

入排标准

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

入选标准

  • · Minimum score of the Montreal Cognitive Assessment (MoCA) (27 points);
  • Regular antiparkinsonian pharmacological treatment;
  • Staged from I to III on the modified Hoehn & Yahr scale.

排除标准

  • · Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests;
  • other associated neurological disease
  • changes in medication in use for Parkinson's disease for at least sixty days before the start of the study

结局指标

主要结局

Change in Function mobility

时间窗: Before (T0) and immediate after vibration (T1)

The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair

Change in static balance

时间窗: Before (T0) and immediate after vibration (T1)

The indirect center of pressure (COP) was acquired by the baropodometric static platform (Sensor Medica). The patient was instructed to position himself on the platform with his arms relaxed along his body, in the usual posture and looking towards the horizon, with a postural adaptation time of 30 seconds. The collection started without being informed to the patient. The averages of the three acquisitions of the following measures were analyzed of center of pressure

Change in Static and dynamic balance

时间窗: Before (T0) and immediate after vibration (T1)

The assessment of static and dynamic balance using the Biodex Balance System (BBS) tool, capable of evaluating the displacement of the center of mass in the anteroposterior and laterolateral axes on a circular platform that can oscillate up to 20 ° in all directions in the horizontal plane. Static balance was performed using the Postural Stability Test, while dynamic balance was assessed using the Limits of Stability Test. The MiniBest test was performed to assess dynamic balance. The test consists of the application of 14 tasks that measure the patient's dynamic balance in different positions, through 14 items, with scores ranging from zero to two

Change in foot pressure

时间窗: Before (T0) and immediate after vibration (T1)

The direct foot pressure was acquired by the baropodometric static platform (Sensor Medica).The patient was instructed to position himself on the platform with his arms relaxed along his body, in the usual posture and looking towards the horizon, with a postural adaptation time of 30 seconds. The collection started without being informed to the patient. The averages of the three acquisitions of the following measures were analyzed: (i) maximum pressure in the forefoot; (ii) maximum pressure in the midfoot and (iii) maximum pressure in the hindfoot.

次要结局

  • Change in Cadence of gait(Before (T0) and immediate after vibration (T1))
  • Change in Risk of falls(Before (T0) and immediate after vibration (T1))
  • Change in support phase of gait(Before (T0) and immediate after vibration (T1))
  • Change in swing phase of gait(Before (T0) and immediate after vibration (T1))
  • Change in Functionality assessment(Before (T0) and immediate after vibration (T1))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria das Graças Rodrigues de Araújo

Maria das Graças Rodrigues de Araújo

Universidade Federal de Pernambuco

研究点 (2)

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