Age Dependents Benefits of Virtual Reality Rehabilitation: Single Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Box and Block Test
研究概览
简要总结
ntroduction: Parkinson's disease (PD) is characterized as a neurodegenerative disorder associated with progressive loss of dopamine in the basal ganglia region, resulting in classic motor symptoms such as bradykinesia, rigidity, postural instability and tremor. Such symptoms end up affecting the functionality of the upper limbs (MMS) in this population. In recent years, Virtual Reality (VR)-based therapy has been gaining popularity, but studies in the area are still lacking. Objective: To verify the benefits of virtual reality in individuals with PD above 65 years of age and in individuals below 65 years of age in the functionality of the upper limbs and to identify possible differences between them. Methodology: This is a randomized clinical trial, in which the evaluators will be separated into two experimental groups. Subjects with PD will be randomized into two groups: Group 65 years or over (GI1), and Group below 65 years of age (GI2). Both will receive treatment with virtual reality games in a non-immersive environment (flat screen) through the Leap Motion Controller (LMC) device. Both treatments will focus on large and fine upper limb tasks, in a protocol with 4 activities and duration of approximately 27 minutes, twice a week, for eight weeks. The two groups will be evaluated in three moments: before the intervention and immediately after 8 weeks. They will be analyzed manual dexterity through the Box and Block test and the Nine Hole Peg Test, Activities of Daily Living level through the TEMPA test and part II of the unified PD assessment (MDS-UPDRS II); motor assessment (part III) of the MDS-UPDRS ; cognition by Montreal Cognitive Assessment (MoCA); quality of life through the PD questionnaire (PDQ-39);. It is expected that this study will show that the treatment applied to the younger population presents better results when applied to the older population.
详细描述
Parkinson's disease (PD) is characterized as a complex neurological disorder, with classic motor symptoms that are mainly associated with the development of Lewy bodies within nerve cells and with the loss of dopaminergic neurons in the substantia nigra. Among the most characteristic motor symptoms of the disease, tremor, rigidity, bradykinesia, postural instability and gait difficulty are included. Consequently, such motor comorbidities directly impact the patient's life, affecting quality of life, increasing the risk of falls, and decreasing independence in general. PD is currently the second most prevalent neurodegenerative disease (after Alzheimer's disease), with a rate of 14 affected per 100,000 inhabitants; when considering the population over 65 years old, the values rise to 160 affected per 100,000 inhabitants. Approximately 60,000 new cases of PD are diagnosed each year in the United States, in addition to the more than one million cases already diagnosed. In Brazil, it is estimated that 200,000 individuals have PD in the general population, with a high prevalence in people aged between 60 and 79 years. About 36,000 new cases arise in the country each year. The incidence rate of Men-Women varies between 1.3 and 2.0 in most of the recorded data. In 2012, Noyce et al. analyzed 30 environmental factors that could be related to the development of PD, among which those that were highly significant: exposure to pesticides, previous injury to the skull region, living in a rural area, use of beta-blockers. , workers in rural areas and consumption of water from wells. Among the protective factors found are: smoking, use of non-steroidal anti-inflammatory drugs, caffeine consumption, use of calcium channel blockers and alcohol consumption. Among the genetic factors best described in the literature are the SNCA genes, which encode the alpha-synuclein protein; mutations in LRRK2; mutations in the GBA gene, which encodes the beta-Glucocerebrosidase enzyme, which is the main genetic risk factor found until then for the development of PD.
Lewy bodies were first described in 1912 by Friedrich Henrich Lewy, becoming a major pathological marker of PD. They are found inside neurons and are made up of neurofilaments with aggregates of alpha-synuclein and ubiquitin. In 2007, through the study by Wakabayashi, he showed that Lewy bodies were not directly related to the causes of PD, but to its symptoms.
In general, the pathophysiology of PD is characterized by a progressive neuronal loss of the compact part of the substantia nigra of the midbrain, requiring a loss of more than 60% for the main symptoms of the disease to appear. However, in addition to the deficit in the dopaminergic pathway, other neurotransmitters may also be involved in the pathophysiology of PD. In the noradrenergic system, the locus coeruleus, presents the loss of 50 to 80% of pigmented neurons, in addition to the reduction of neurons in the dorsal vagus nucleus and in the supraoptic and paraventricular hypothalamic nuclei, accompanied by a decrease in the function of the noradrenergic projections; In the serotonergic system, a reduction of 57.8% of neurons in the dorsal raphe nucleus is observed; And in the cholinergic system, a reduction of 50 to 60% of cholinergic neurons in the dorsal raphe nucleus was observed.
In 2003, a study developed by Braak et al. showed that PD begins in Meissner's gastric autonomic plexus and in the olfactory neural endings, propagating to the brainstem (midbrain), precisely in the dorsal vagus nuclei, glossopharyngeal nucleus, olfactory and in the intermediate area. From there, evolution is divided into 5 more stages, namely: 1 - raphe nuclei, gigantocellular nucleus and locus coeruleus; 2 - compact part of the substantia nigra; 3 - forebrain areas of the temporal mesocortex; 4 - areas of association of the frontal neocortex; 5 - neocortex association areas, premotor and motor areas.
The main motor symptoms of PD are bradykinesia, hypokinesia, akinesia, tremor and rigidity, as well as balance and gait deficits. In addition, cognitive disorders, memory deficits, problems related to visuospatial dysfunction, difficulties in performing sequential and repetitive movements, freezing and slow psychological responses are often present. Decreased writing and problems in the voice and swallowing of individuals can also be observed. Among the main clinical symptoms of PD is tremor, which in about 50% of cases begins in the distal extremities. In rest situations, the decrease or disappearance of this symptom is noticeable, which returns if the individual maintains a more prolonged action or posture. Bradykinesia (slowness of movement) is due to an imbalance between the inhibitory and excitatory systems, resulting from the absence of dopamine in the striatum, affecting mainly automatic movements, generating a general poverty of movement and frequent complaint of weakness. Patients with PD have a high chance of acquiring a posture with their center of gravity forward, generating a bent or flexed posture. There is also a decrease in postural reflexes, such as protective extension, balance, and righting reactions. The gait presents itself as a slow, shuffling gait with a shortened stride length.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease diagnostic;
- •Classified as I-III on the Hoehn & Yahr motor staging scale;
- •Are over 18 years old (above this, without age restriction).
- •Residents in the city of Porto Alegre / RS.
- •Have signed an informed consent form.
- •To identify subjects with manual dexterity deficits, a cut-off score of 21.1 seconds for the dominant limb and 22.3 seconds for the non-dominant limb was used for male subjects, and 19.9 seconds for the dominant limb and 21.4 seconds for the non-dominant limb was used for female subjects on the Nine-Hole Peg Test (9HPT)
排除标准
- •Do not show the understanding of the games on the first day of familiarization;
- •Have a cerebral pacemaker implant;
- •Have recent injuries or limitations that make the MMSS impossible.
- •Do not perform / abstain from two appointments out of the 16 proposed in the intervention protocol, regardless of the group that will be allocated.
结局指标
主要结局
Box and Block Test
时间窗: Pre-intervention and post-intervention (8 weeks of intervention).
For the application of the manual dexterity test, a wooden box measuring 53.7 cm is required, with a wooden partition that is higher than the edges of the box, separating it into two compartments of equal dimensions. The blocks are also made of wood and in the form of colored cubes (primary colors) measuring 2.5 cm on each side, totaling 150 units, divided equally by color. When starting the test, always with the dominant hand. The examinee will have 15 seconds of training. Then the transported blocks must return to the original compartment. The applicator must use a stopwatch to be able to interrupt the tasks after 1 minute. Repeat the test with the non-dominant hand. The test result is expressed by a score that indicates the number of blocks transported from one compartment to another per minute (blocks/minute)
次要结局
- UPDRS part II and III.(Pre-intervention and post-intervention (8 weeks of intervention).)
- Nine Hole Peg Test(Pre-intervention and post-intervention (8 weeks of intervention).)
- Montreal Cognitive Assessement(Pre-intervention and post-intervention (8 weeks of intervention))
- TEMPA test (Test d'Évaluation des Membres Supérieurs de Personnes Agées)(Time Frame: Pre and Post Immediate intervention)
- Simulator sickness questionnaire(up to 1 week)
- System usability scale(immediately after the intervention)
- Handrigrip Strength(Pre-intervention and post-intervention (8 weeks of intervention))
研究者
Fernanda Cechetti
Clinical Professor
Federal University of Health Science of Porto Alegre
