Motor Recovery Following the Comprehensive Intensive Rehabilitation Program After Stroke Implementing the International Classification of Functioning, Disability and Health Model: A Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Change from Baseline Patient-reported Outcomes Measurement Information System - Global Health at 3 weeks, 3 and 12 months
研究概览
简要总结
In this study, the investigators aim to assess the effectiveness of the Comprehensive Intensive Rehabilitation Program After Stroke implementing the International Classification of Functioning, Disability and Health model, and to compare it with two cohorts receiving Comprehensive Intensive Rehabilitation Program After Stroke of the same length but different in physical therapy content (program implementing modern technological approach and neuroproprioceptive "facilitation and inhibition"). Moreover, control group will undergo standard care.
详细描述
Aim of this study is to define the predictors of effective rehabilitation after stroke. In order to compare the improvement from many different aspects, a wide range of patient characteristic, self-report measures and clinical assessments according to framework of the International Classification of Functioning, Disability and Health (ICF) model, and other data will be collected. The investigators consider, as the most important aspect, the subjective feelings of the participants about how they improved. Therefore, the Goal Attainment scale together with the Patient-reported Outcomes Measurement Information Global Health, and the World Health Organization Disability Assessment Schedule were chosen as primary outcomes. As secondary outcomes, will be measured the motor, cognitive, psychological, speech and swallowing functions and the functional independence. Moreover, focus will be placed on the identification of novel biological molecules reflective of effective rehabilitation.
This clinical trial will test the following scientific hypotheses:
I. COMIRESTROKE under all three settings has a positive influence on all outcomes and higher effect than control group. .
II. COMIRESTROKE - ICF will have the highest impact on primary outcomes (GAS, PROMIS, WHODAS 2.0) and on such secondary outcomes that were identified as treatment goals. Furthermore, it is expected that the highest impact will be on the primary outcomes in the follow-up (three and twelve months after finishing the rehabilitation).
III. COMIRESTROKE - NEFI will have the highest effect on the secondary outcomes, mainly on motor functions. Moreover, it will most significantly lead to the initiation of plastic and adaptive processes, assessed by the level of lncRNAs in the peripheral blood.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All patients meeting the above criteria will be invited to participate and asked to provide a written informed consent. They will be randomly assigned (1:1:1:1) as soon as possible, but always within 48 hours of admission, into one of the four interventions (represented by Group 1, 2, 3 or 4) using offsite-independent randomization protocols (www.randomization.com). Concealed allocation will be performed using sequentially numbered opaque sealed envelopes only accessible by research personnel with no involvement in the trial.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •after first ischemic stroke
- •early sub-acute phase
- •slight to moderately severe disability [2 - 4 on the Modified Rankin Scale]
- •0 - 2 on the Pre-Stroke Modified Rankin Score
- •potential to accept 4 hours of comprehensive rehabilitation per day and to profit from physiotherapy
- •minimal or moderate motor deficit of upper or lower extremities (on NIHSS Item 5 or 6 scores 1-3 points)
- •able to perform activities of daily living prior to stroke event (0 - 2 on the Pre-Stroke Modified Rankin Score)
- •Czech is participants' native language or its knowledge is at the level of the mother tongue
排除标准
- •low level of consciousness (vegetative state and/or minimally conscious state); severe cognitive decline that would interfere with administration of the tests, premorbid illiteracy, severe visual and/or auditory deficit that would prevent proper completion of the tests
- •behavioural disorders and/or lack of cooperation with therapist
- •severe medical problems with a poor prognosis, (e.g., severe frailty, advanced and incurable cancer, fracture, cardiovascular disorders as chronic heart failure NYHA III, IV, symptomatic coronary artery disease Angina Severity Class III, IV, respiratory insufficiency as chronic obstructive pulmonary disease GOLD IV, and other severe disease)
结局指标
主要结局
Change from Baseline Patient-reported Outcomes Measurement Information System - Global Health at 3 weeks, 3 and 12 months
时间窗: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks), Follow up assessments (3 and 12 months after the admission respectively)
a 10 item scale that assesses an individual's physical, mental, and social health where a standardized score with a mean of 50 and a standard deviation of 10, so a person with a T-score of 40 is one SD below the mean.
Change from Baseline World Health Organisation Disability Assessment Schedule 2.0 at 3 weeks, 3 and 12 months
时间窗: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively).
the 36-item questionnaire, higher score means higher disability
Change from Baseline Goal Attainment scale at 3 weeks, 3 and 12 months
时间窗: Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks). Follow up assessments (3 and 12 months after the admission respectively).
Each goal is rated on 5-point scale (-2 much less than expected, 0 achieved the expected level, 2 much more than expected). Higher score means a better outcome.
次要结局
- Change from Baseline Jamar Hydraulic Hand Dynamometer at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline a frequency for which the smoothed power spectral density is maximal at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline Naming Pictures and Their Equipment at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline The Mississippi Aphasia Screening Test at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline Image Naming Test at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline Neuro - Quality of Life depression at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline The Montreal Cognitive Assessment at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline Nine Hole Peg Test at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline The Gugging Swallowing Screen at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline Amnesia Light and Brief Assessment at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline a power of the signal in band from frequency 1 to 2 at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline The 10 Metre Walk Test at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline The 3F Test - Dysarthric Profile at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline Action Research Arm Test at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline Motor Activity Log at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline Timed Up And Go at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline Berg Balance Scale at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline The 6 Minute Walk Test at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
- Change from Baseline Functional Independence Measure at 3 weeks(Pre-assessment (baseline testing), Post-assessment (immediately after the end of three weeks))
研究者
Kamila Řasová
associate professor PhDr. Kamila Řasová, Ph.D.
Charles University, Czech Republic