EFFECTS OF CONSTRAINT-INDUCED MOVEMENT THERAPY Versus CONVENTIONAL PHYSICAL THERAPY ON FUNCTIONAL RECOVERY AND QUALITY OF LIFE AFTER STROKE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- motor skills in the upper limbs
研究概览
简要总结
It is estimated that worldwide, about 15 million people are affected by vascular accident (CVA) per year, and in Brazil, the stroke is a major cause of death and disability, generating too much economic and social impact by generating motor sequelae , sensory and cognitive arising from blockage or rupture of blood vessels. Among the motor sequelae is the hemiparesis, which affects about 80% of cases with consequent impairment of the quality of life of individuals. However, physical therapy has shown to facilitate return of the function of these individuals, while minimizing the sensorimotor deficits for promoting neuronal plasticity through the motor relearning. Among the features of physical therapy are the conventional physical therapy techniques, Therapy and Restriction of Movement Induction (TRIM) and the Mental Practice. In view of this, the objective of the study is to compare the application of conventional physiotherapy protocols and TRIM and / or mental practice on the morphometric features, functionality and quality of life of post-stroke hemiparetic subjects in the chronic phase. 60 volunteers will be selected, of both sexes, aged between 45 and 80 years with a clinical diagnosis of stroke, with hemiparesis in the chronic phase were divided into four groups (N = 15): control group (CG), TRIM Group (GT), Mental Practice group (GPM) and group TRIM + Mental Practice (GTPM) to perform specific exercises for each group for three times a week, totaling 24 sessions. Volunteers will be evaluated in four times through the Fugl-Meyer Assessment scale (FMA) adapted and Motor Ability Test of the Upper Limb (THMMS) and to assess the Quality of Life will be used Quality Scale Specific Life Vascular Accident brainstem (EQVE-AVE) and oxidative stress analysis by collecting blood and electromyography for muscular activity. After the research data will be tabulated on an Excel spreadsheet to perform intergroup and intragroup comparisons between the four evaluation times, which will be used for data analysis the BioEstat® 5.2 program, the choice of tests for analysis dependent on the statistical distribution types found and the homogeneity of their variances.
详细描述
The sample is composed of 60 volunteers of both sexes, with a clinical diagnosis of stroke (CVA) with injury over six months time that characterizes the chronic stage of the disease and present hemiparesis in upper limb.
PROCEDURES AND DATA COLLECTION
The research will be divided into the following steps:
STAGE 1: The search will begin with an invitation to volunteers to participate in the study, through posters and verbal invitation. Then, a pre-selection candidates by applying MMSE will be performed, Jaeger card and Whisper test in order to evaluate the existence of cognitive impairment, visual and auditory respectively. If they can make up the sample, volunteers will be selected as meeting the inclusion and exclusion criteria, and researchers will deliver two-way the IC explaining how occur the research objectives of the Office and application of the Protocol and deliver two-way also statement of photographs and footage authorization for display permit photos and footage. It is noteworthy that both routes of the term and Declaration will be signed on every page by volunteers, which will be a copy of each document with the same.
Prior to the procedures and data collection, the researchers will be trained in the application of all instruments of evaluation and handling of resources to be used in the treatment of volunteers.
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)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •will be included in the study volunteers with stroke diagnosis for six months or more lesions.
- •showing hemiparesis
- •with at least 20 of passive extension handle and 10 for the fingers (TREVISAN; TRINTINAGLIA, 2010)
- •who are aged between 45 and 80 years
- •independent of race, color and cultural socioeconomic status, that are experiencing higher score to 24 points on the MMSE, which are not performing physical therapy at the time of the study and who agree and sign the consent form.
排除标准
- •volunteers with a diagnosis of stroke at least six months
- •stroke recurrence
- •double hemiparesis
- •hemiplegia, which present associated diseases
- •uncontrolled hypertension according to the Brazilian Guidelines on Hypertension (systolic blood pressure (BP)> 90 and <140 diastolic pressure (DP )> 50 and <90) and heart rate (HR) 80-100 bpm
- •respiratory rate (RR) from 18 to 20 rpm, with 36 temperature, diabetes, heart disease, apraxia, aphasia, that are experiencing pain and deformities upper limb, that are experiencing cognitive impairment, visual and hearing impairment, which will be assessed using the Mini Mental State Examination -MEEM tests (Appendix a) with scores below 24 points or taking into account score for illiterates, Jaeger Card (ANNEX B) and Test Whisper (ANNEX C) respectively
- •who performs physical therapy at the time of the study, who do not agree and refuse to sign the Informed Consent
研究组 & 干预措施
CONVENTIONAL PHYSICAL THERAPY group
physical exercises divided into three phases:
- stretching, strengthening and/or mobilization;
- functional training of the affected muscles;
- functional training of the paretic limb.
干预措施: THERAPY CONTROL AND MOVEMENT OF INDUCTION (Other)
containment therapy induced
healthy side is restricted with splinting and exercises in hemiparetic member: carry out functional tasks individually. Each task will be held for 5 minutes, totaling 60 minutes of service
干预措施: THERAPY CONTROL AND MOVEMENT OF INDUCTION (Other)
结局指标
主要结局
motor skills in the upper limbs
时间窗: pre-treatment and after 8 weeks
For evaluating the functionality of the Fugl-Meyer Assessment Scale was developed with the objective of evaluating six aspects of the patient, range of motion and pain, motor function, sensitivity, balance, coordination and speed. But the Motor Ability Test of the Upper Limb (THMMS) to measure quantitative and qualitative aspects of ADLs involving the upper limb in patients who have suffered strokes.Scales do not have measurement units only get a total points.
quality of life
时间窗: pre-treatment and after 8 weeks
Quality of Life Scale for Stroke (EQVE-AVE) which consists of 49 items, divided into 12 areas divided into energy, family role, language, mobility, humor, For the assessment of quality of life will be used Specific personality, self-care, social role, reasoning, upper limb function (MS), vision and work / productivity. Will be evaluated pre-treatment and after 24 sessions.
electromyography
时间窗: pre-treatment and after 8 weeks
For the evaluation of electrical muscle activity through electromyography through surface electrodes analyzed musculatures flexors and wrist extensors and elbow (median frequency, raw).
次要结局
未报告次要终点
研究者
Larissa Salgado de Oliveira Rocha
researcher
Universidade Metodista de Piracicaba