EFFECTIVENESS OF INTENSIVE TREATMENT WITH ROBOTIC PLUS VIBRATION TO SENSITIVITY AND FUNCTIONALITY REHABILITATION IN STROKE PATIENTS
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from Fugl Meyer Assessment scale for the upper limb at 1,5 months (change): Post-treatment period
研究概览
简要总结
The Amadeo® Manual Robotic System (Tyromotion GmbH, Graz, Austria) is designed for rehabilitative treatment of the hand and fingers providing robot-assisted exercise for the finger flexors and extensors. This system has a controlled position, active, active-assisted and passive exercise mode, it also allows isometric exercises with visual feedback provided during computerized games that emphasize flexion and extension. Another of the functions that this device presents and that differentiates it from other handheld robotic systems is its vibration function. Through sensors that are placed on the fingertips, providing a vibratory proprioceptive stimulus of different frequencies.
Currently, there are no published trials on the efficacy of the vibration of this device and its consequent improvement in the sensitivity and functionality of patients with hemiparesis after stroke. Investigations have been conducted in patients with peripheral lesions and in the healthy population. A preliminary study with monkeys demonstrated that the frequency of the vibration presents better results when the muscle stretch receptors are driven by a high frequency vibration, activating the neurons corresponding to the motor cortex and in the 3rd primary sensory area. More recent studies have shown the efficacy of focal vibratory stimulation applied to the wrist and forearm muscles, specifically the application to the tendon of the stimulated muscle.
Regarding the most appropriate form of stimulation, the most important determining factors to highlight are the frequency of application, the duration and intensity and the time of application. The mechanism of action of local muscle vibration is to stimulate various receptors. Meissner corpuscles respond best around 40 Hz, while Vater-Pacini corpuscles around 100 Hz. Together, they are also known as rapidly adapting cutaneous receptors. In contrast, Merkel-Ranvier cells and Ruffini corpuscles are called slow-adapting and classically described as sensitive to sustained pressure. That is why authors of different studies have focused on high frequency vibration of 300 Hz, for 30 minutes. 3 times per week. The duration of vibratory stimulation, different studies show the effects of vibration and changes in the cortex after performing the treatment constantly, for about ten days, intensively three to four days a week, observing long-term changes in terms on cortical excitability.
详细描述
The rehabilitation of the stroke patient is an individual process, adapted to each type of patient, continuous and oriented by objectives whose main purpose is to treat and / or compensate for deficits and disability to achieve the maximum functional independence achievable in each case, facilitating independence and reintegration into the family, social and work environment. The stroke rehabilitation program is a complex process that requires a multidisciplinary approach to existing motor, sensory and / or neuropsychological deficiencies through re-education techniques based fundamentally on the phenomenon of neuronal plasticity and task-oriented rehabilitation.
There is evidence that supports the need to work on the intensity and repetition of motor skills in treatments to promote neuroplasticity and motor relearning. Considering the significant advances in information and communication technology (ICT) and more specifically the rapid development and deployment of technology, a number of recent systematic and non-systematic reviews highlight the increasing use of wearable devices to provide intensity to rehabilitation after of suffering a stroke including robotics, virtual reality, functional electrical stimulation (FES).
Robot-assisted therapy for post-stroke rehabilitation is relatively new as a complementary tool to physical therapy, through which patients practice their limb and paretic hand, resorting to or resisting the force offered by these robots.
The strongest point of these devices is the "attractive" variety of exercises that provide the user with great motivation, in addition to the "intensity" factor in the therapies. These factors allow for rehabilitation treatments with robotic technology, which cannot be achieved with any conventional rehabilitation therapy. The Amadeo® Manual Robotic System (Tyromotion GmbH, Graz, Austria) is designed for rehabilitative treatment of the hand and fingers providing robot-assisted exercise for the finger flexors and extensors. This system has a controlled position, active, active-assisted and passive exercise mode, it also allows isometric exercises with visual feedback provided during computerized games that emphasize flexion and extension.
Another of the functions that this device presents and that differentiates it from other handheld robotic systems is its vibration function. Through sensors that are placed on the fingertips, providing a vibratory proprioceptive stimulus of different frequencies.
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 (Outcomes Assessor)
盲法说明
Assessments will be made by researches blinded for the patient´s group
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: people aged between 30 and 80 years.
- •Diagnosis: stroke in the right hemisphere.
- •Right-handed.
- •Present hemiparesis or left hemiplegia with paralysis / paresis in his affected hand.
- •People with sensitivity alterations as a result of stroke.
- •Evolution: subacute patients (from three months to one year, and who at the same time meet the subacute criteria of the IMSERSO document of the model of care for people with brain damage, as well as chronic patients (after one year, and who meet the chronicity criteria of the IMSERSO document of the model of care for people with brain damage).
- •People without other concomitant pathologies that affect mobility and / or sensitivity
- •The acceptance and signing of the informed consent by the user.
- •Present a score equal to or greater than 24 points in the Mini-Mntal State Examination (MMSE).
- •Patients can be admitted or outpatient as long as they meet the above criteria and belong to the advanced neurorehabilitation unit.
排除标准
- •Patients with Aphasia and / or Apraxia.
- •Patients with serious difficulties in communication.
- •Patients who do not present limitation of mobility and / or sensitivity.
- •Other concomitant diseases.
- •Diagnosis: left or posterior hemisphere stroke.
- •Scores less than 24 points on the MMSE.
- •Age over 80 years and under 30 years.
- •The non-acceptance and signing of the informed consent by the subject.
- •Evolution: acute patients less than three months of evolution.
结局指标
主要结局
Change from Fugl Meyer Assessment scale for the upper limb at 1,5 months (change): Post-treatment period
时间窗: Post-treatment (1,5 months)
Motor Function
Change from Fugl Meyer Assessment scale for the upper limb (change): Pre-treatment
时间窗: Pre-treatment
Motor Function
次要结局
- Stroke Impacte Scale.(One month and a half)
- Questionnaire of satisfaction with technology(One month and a half)
- Motor Activity Log(One month and a half)
- Semmes-Weinstein ® monofilaments for sensitivity assessment(One month and a half)
研究者
Josue Fernandez Carnero
Clinical Professor
Universidad Rey Juan Carlos