Effects of Kinesthetic Stimuli Provided by the Physiotherapist During XBOX Kinect Training on the Functionality of People With Parkinson's Disease: A Blind Randomized Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- International Falls Effectiveness Scale (FES-I)
研究概览
简要总结
A single-blind, parallel-group, randomised trial will be conducted in Sao Paulo, Brazil. People with Parkinson's Disease (PD) will be recruited at "Brazil Parkinson Association" (BPA), a non-governmental association of PD care, and randomly allocated in two groups: the Movement Guidance Group (MVG) and NO-MVG Group. Both groups will perform XBOX Kinect training for balance and gait. However, the MVG will receive kinesthetic stimuli manually by the physiotherapist (PT) to improve the participant movements while the NO-MVG Group will not, the presence of the PT will be restrict to only guarantee the participant safety.
详细描述
BACKGROUND: Despite evidences indicate the benefit of motor interventions based on video games in people with Parkinson's Disease (PD), practice guidelines for the therapeutic use in physiotherapy were still not established. Although visual and auditory stimuli provided by video games are pointed as one of the main advantages for their therapeutic use, the effects of kinesthetic stimuli offered through physical therapist manual intervention during this type of training in people with PD have not been investigated yet. The answer to this question is relevant to guide the physical therapist (PT) conduct during this kind of intervention.
PURPOSE: To compare the effects of motor training using video games with and without kinesthetic stimuli offered by physical therapist manual guidance during intervention on the functionality of people with PD.
METHODS: A blind randomized clinical trial in people with idiopathic PD, staging of 1 to 3 according to disability scale of Hoehn and Yahr, will be performed. Participants will be randomized into two groups: the Movement Guidance Group (MVG) and NO-MVG Group. Both groups will receive 8 individual sessions, twice a week, for 4 weeks. Each session consist of 10 minutes of warm-up and 40 minutes of XBOX Kinect training for balance and gait. In the MVG Group, the PT will provide kinesthetic stimuli by assisting manually the participant movements. In the NO-MVG Group, the involvement of the PT will be restricted to ensure participant safety. The two groups will be evaluated before (BT) and after (AT) training and after 60 days (follow-up). A blind physiotherapist will conduct the assessments. Measurements are categorized according to the International Functioning Classification (ICF), those associated with the activity level were established as primary measures: Balance Evaluation Systems Test (BESTest); International Falls Effectiveness Scale (FES-I); 30-second Gait Test; Six Minute Walk Distance (6MWD); Five Times Sit to Stand Test (FTSTS) and Unified Parkinson's Disease Rate Scale (UPDRS) session II. Secondary measures were the evaluation of function using UPDRS session III; Rapid Turns Test (RTT); Montreal Cognitive Assessment (MOCA); Geriatric Depression Scale (GDS-15), and participation using the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).
STATISTICAL ANALYSIS
An ANOVA to repeated measures will be use, having as factors: group (MVG Group and NO-MVG Group) and evaluations (BT, AT and FU). Followed by post hoc Tukey Test to the significance factors. A significance of 5% will be considered.
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 (Investigator)
盲法说明
A experient physical therapy will be responsible for assessments of all participants without knowing the group allocation of which.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of London criteria
- •Active treatment with levodopa
- •Stages 1, 2, and 3 according to Hoehn and Yahr Classification
排除标准
- •Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment
- •Score greater than or equal to 6 on the geriatric depression scale
- •Severe respiratory and / or cardiovascular conditions
- •Visual and / or auditory deficit that cannot be corrected with glasses or a hearing aid;
- •Other previously detected orthopedic or neurological diseases, other than Parkinson's Disease, that may interfere with the individual's performance
- •Previous experience with Microsoft XBOX Kinect® games
- •And being in rehabilitation in another location concomitant to this training.
结局指标
主要结局
International Falls Effectiveness Scale (FES-I)
时间窗: Change from baseline up to 3 months
It presents questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can range from 16 (no concern) to 64 (extreme worry).
Balance Evaluation Systems Test (BESTest)
时间窗: Change from baseline up to 3 months
Balance Evaluation Systems Test (BESTest) measures balance. It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.
Five Times Sit to Stand
时间窗: Change from baseline up to 3 months
A measure of functional mobility that assists in the identification of insufficient strength and muscle strength of the lower limbs, assessing balance and identifying people at risk of falls. In this task, the individual is instructed to sit and get up from a chair, without armrests, for 5 times without stopping as quickly as possible. The evaluator measures the time the subject performs this task.
Unified Parkinson Disease Rating Scale - Session II
时间窗: Change from baseline up to 3 months
It is a gold standard scale used to assess and monitor PD progression. It consists of 42 items and divided into four segments: Part I (non-motor aspects of daily life), Part II (motor aspects of daily life), Part III (motor evaluation) and Part IV (motor complications). a score from 0 to 4 is established, the lower the score the better the individual's condition. In Part II, the questions are conducted by the evaluator and the answers are based on the self-reported report by the evaluated person regarding his motor performance in daily life activities.
30-second Gait Test
时间窗: Change from baseline up to 3 months
Functional mobility test that assesses gait performance under the influence of a verbal fluency cognitive task (speaking as many words that start with a certain letter established by the evaluator), in which the individual must walk continuously for 30 seconds and, when multitasking, he or she is instructed to perform both without interruption (command = "perform both tasks at the same time, without stopping talking or walking"). The evaluator measures the distance that the subject was able to travel in a single task and in a double task.
Six Minute Walk Distance
时间窗: Change from baseline up to 3 months
A gait assessment method that measures the maximum distance a person can walk in six minutes and measures maximal cardiorespiratory functions.
次要结局
- Geriatric Depression Scale(Change from baseline up to 3 months)
- Montreal Cognitive Assessment(Change from baseline up to 3 months)
- Unified Parkinson Disease Rating Scale - Session III(Change from baseline up to 3 months)
- Rapid Turns Test(Change from baseline up to 3 months)