跳至主要内容
临床试验/NCT06278623
NCT06278623招募中不适用

Effects of Focal Muscle Vibratory Energy in Patients With Parkinson's Disease: Pilot Prospective Observational Study.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2023年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
23
试验地点
1
主要终点
Tinetti scale

研究概览

简要总结

Postural instability has a major impact on the mobility and daily life activities of Parkinson's disease (PD) patients as it often leads to reduced mobility, insecure stance and falls.

The aim of this study was to evaluate the effect of focal vibration on the static and dynamic balance of a group of Parkinson's disease patients with Hoehn and Yahr (HeY) stage II-III. They underwent three weeks of focal muscle vibration applied to the quadriceps, soles of the feet and trapezius muscles bilaterally in addition to conventional physiotherapy . The static and dynamic balance was assessed at baseline (T0), after 3 weeks of treatment (T1) and after 1 month from the last treatment (T2) with the Tinetti scale and stabilometry evaluations.

详细描述

Parkinson's disease (PD) is a chronic, highly disabling neurodegenerative disorder characterized by bradykinesia, resting tremor, rigidity and postural instability . Postural instability has been shown to have a major impact on the autonomy, mobility and quality of life of these patients as it often leads to insecure stance and falls . Balance control is a complex system involving the integration of vestibular, visual and proprioceptive sensory information. Somatosensory information is derived from a variety of sources, most notably the cutaneous mechanoreceptors in the skin and the muscle spindles . It is well known that a decline in skin sensitivity and proprioceptive input naturally occurs with aging. Moreover, kinesthetic sensory deficits may occur due to systemic and neurologic disorders (e.g., diabetes, stroke etc.). Previous studies have demonstrated that the integration of sensory information is abnormal in PD patients with strong repercussions on motor function, posture, static and dynamic balance and greater reliance on visual input for postural control . The effectiveness of current treatments on postural instability and kinesthetic deficits in PD is controversial. Bartolic et al. observed improvement in postural control after treating rigidity with apomorphine. Wright and colleagues [6] suggest that axial kinesthetic sensitivity worsens with levodopa. Furthermore, important side effects and loss of therapeutic efficacy after years of use of dopaminergic agonists represent a major clinical challenge. Muscle vibration is a safe, non-invasive rehabilitation technique that holds promise for improving mobility and balance in moderate to severe PD patients. It consists of local vibrations applied on selected muscles or tendons by means of a mechanical device.

Stimulation of Ia afferent fibers from muscle spindles and cutaneous receptors strongly increases the exteroceptive and proprioceptive input to the central nervous system (CNS).

This has been shown to induce a plastic modulation of the primary sensory motor cortex andspinal reflexes, with long lasting positive effects on muscle tone and motor control Despite good results obtained in several other neurological conditions, such as post stroke spatial heminattention, spastic hypertonia and motor control impairment , only a few studies exist on the use of focal vibratory energy for posture and gait disorders in Parkinson's disease. Most of the existing experiments in the literature are about whole-body vibration (WBV) which has shown limited efficacy on stability and movement control In contrast, focal vibration applied over the cervical and soleus muscles , and on quadriceps and paraspinal muscles , in conjunction with conventional physiotherapy, has shown positive effects on the patient's balance, risk of falling and quality of gait.

Despite a consistent body of literature on the use of muscle vibration in rehabilitation, there is currently insufficient evidence regarding its application in patients with Parkinson's disease, including muscle targets, duration and frequency of the treatment and technical parameters. Based on these premises, we aimed to evaluate the effects of focal vibration on static and dynamic balance of patients with Parkinson's disease.

This is a prospective, observational, pilot study. Chronic patients with idiopathic Parkinson's disease were recruited from the Physical and Rehabilitation ward of the Agostino Gemelli Foundation University Hospital of Rome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Tinetti scale

时间窗: Evaluation was performed at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2)

balance and deambulation scale. The Tinetti scale, also known as performance-oriented mobility assessment (POMA), It is a standardized screening modality for gait and balance disorders. It is applied to screen different patient populations including elderly patients and patients with Parkinson's disease. The test assesses a patient's balance and gait using a standardized scoring system comprising 16 items with a maximal score of 28. A score ≤ 18, a score between 19-24 and a score ≥ 25 reflect an overall high, medium and low risk of falls, respectively

次要结局

  • Stabilometric Test(Evaluation was performed at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2))
  • NRS numeric rating scale of pain(Evaluation was performed at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2))
  • Mc Gill Pain questionnaire(Evaluation was performed at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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