Application of the Concept of Proprioceptive Neuromuscular Facilitation in Trunk Control in Patients Admitted to the ICU. (PNF)
2026年5月18日 更新者：Jose Roberto Lapa e Silva、Universidade Federal do Rio de Janeiro
Effects of Applying the Concept of Proprioceptive Neuromuscular Facilitation in Trunk Control in Patients Admitted to the ICU: A Randomized Clinical Trial.
Muscle weakness acquired in the ICU (FAUTI) is related to the functional decline of patients admitted to an Intensive Care Unit (ICU).
For better follow-up, scales such as (Chelsea Critical Care Physical Assessment) CPAx and (Medical Research Council) MRC help to identify early the muscle and functional impairment of these patients.
Early mobilization aims to minimize these effects and therefore the search to reach the highest mobility milestone is constant bedside sitting (BSS) is an important milestone in recovery, associated with better functional results when there is good trunk control, as the coordinated activation of muscles in this region is essential for stabilization and reaching higher postures.
The physiotherapeutic approach focused on the components of the activities and on the patient's participation is crucial, with the therapeutic option of Proprioceptive Neuromuscular Facilitation (PNF).
To evaluate the effect of exercises based on the PNF concept through the Test Control Trunk (TCT) on the trunk balance of patients admitted to the ICU.
This is a randomized, crossover clinical trial, carried out at the Pedro Ernesto University Hospital from June 2026 to June 2027.
Adults hospitalized for more than 48 hours who meet the inclusion criteria will be screened.
and clinical evaluation.
The study consists of two blocks of pre- and post-crossover evaluations, conducted by the same blind evaluator.
Patients will undergo assessments on the first day of BSS, including assessment of the trunk with TCT and assessment of diaphragm mobility and thickness by ultrasound, before and after intervention (PNF or conventional exercises).
Between assessments, there will be a 3-hour rest period.
研究概览
地位
尚未招聘
条件
详细说明
This is a randomized, crossover clinical trial to be conducted in the general ICU of the Pedro Ernesto University Hospital from December 2025 to December 2026.
Patients from the general ICU will be recruited and included are those over 18 years of age, with an ICU stay greater than 48 hours, sitting at the bedside for the first time as indicated by the physiotherapy team, a RASS score greater than or equal to -2 and less than or equal to 1, a score less than or equal to 12 points on the "balance in sitting position" item in the TCT, and a score less than or equal to 2 on item 3 "sitting without support".
Patients will be randomized for clinical evaluation followed by two evaluation blocks (pre- and post-washout).
All evaluations will be performed by the same blinded evaluator.
A screening evaluation will be performed to select individuals according to inclusion and exclusion criteria.
Patients will undergo the following assessments on the first day of SBL: trunk assessment using the Trunk Test Control (TCT), assessment of diaphragmatic mobility and thickness via ultrasound, before and after the intervention (PNF or conventional).
A 3-hour washout period will be considered, during which no motor interventions will be performed by the physiotherapy team on the patients, only care related to the medical and nursing teams.
The first block with these three assessments will be performed in the morning by a blinded evaluator, followed by a three-hour washout period before repeating all assessments in the second block in the afternoon, but this time evaluating the effect of the other intervention (PNF or conventional).
Participants will be randomly selected and assigned to one of the two groups through the random.org
website by a professional independent of the evaluator.
In addition, general information recorded in medical records will be collected, such as demographic data, general assessments, Sequential Organ Failure Assessment Score (SOFA), level of consciousness using the Richmond Agitation-Sedation Scale (RASS), Glasgow Coma Scale, Chelsea Critical Care Physical Assessment Tool (CPAx), and Medical Research Council (MRC) functional scale.
All demographic, clinical, and ultrasound data will be incorporated into an attached assessment form.
研究类型
介入性
注册 (估计的)
58
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Gabriel Gomes Maia
- 电话号码：5521996267494
- 邮箱：gmaiafisio@gmail.com
学习地点
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Rio de Janeiro
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Rio de Janeiro、Rio de Janeiro、巴西、20551-030
- Pedro Ernesto University Hospital
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接触：
- GABRIEL MAIA
- 邮箱：gmaiafisio@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Over 18 years of age
- ICU stay greater than or equal 48 hours;
- RASS scale score greater than or equal to -2 and less than or equal to 1;
- TCT score less than or equal to 12 points on the "balance in sitting position" score less than or equal to 2 on item 3 "sitting without support".
Exclusion Criteria:
- Patients in a coma, with spinal cord instability, metastases, and bone lesions;
- Neuromuscular or neurological diseases
- Discharge from the general ICU before SBL
- Proportional care phase 3;
- Readmissions to the general ICU;
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：standard physiotherapy
This group will undergo conventional physiotherapy according to institutional protocol.
Rehabilitation will be geared towards achieving daily motor milestones (sitting on the edge of the bed, sitting in a chair, standing up, and walking) according to the CPAx scale.
We will record whether patients achieved any milestones during their stay in the ICU and the number of days required to achieve them.
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This group will undergo conventional physiotherapy according to institutional protocol.
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实验性的：Proprioceptive Neuromuscular Facilitation (PNF)
Patients will undergo a protocol that respects the principles and procedures of PNF, as well as the stages of motor control model, such as: mobility, stability, and mobility over stability.
Activities will begin in bed and conclude in the sitting over of the edge.
It will begin with exercises in the right and left lateral decubitus positions: solid flexion and solid extension.
Next, trunk stability exercises will be performed in a seated position at the edge of the bed.
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From its beginnings, PNF has successfully integrated many of the concepts of contemporary neurorehabilitation interventions.
The Philosophy and Basic Principles of PNF, together with the specific spiral and diagonal patterns, make up the cornerstone of PNF.
PNF also includes motor learning and functional retention of newly learned activities with the repetition of a specific demand; the use of the developmental progression of motor behavior that enables patients to create and re-create strategies of efficient functional movement; and the biomechanical and behavioral analysis of motor control.
All activities within PNF intervention are directed towards a functional goal and are relative to the environment in which the goal is to be achieved.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Trunk Control
大体时间：Day 1
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Trunk stability assessment will be performed on the first day of sitting at the bedside, both before and after treatment, for both groups.
The Trunk Control Test (TCT) will be used.
The TCT is a test used as a predictor of return to walking within 18 weeks, when the patient is able to obtain 50 points or more within 6 weeks.
The test examines four simple aspects of trunk movement.
The patient begins the test in the supine position, is asked to roll to both sides, then sit up from the lying position, and finally maintain a balanced position on the edge of the bed with their feet off the ground for a minimum of 30 seconds.
In each aspect, the patient can receive a score of 0, 12, or 25.
The total value is the sum of the four aspects evaluated, totaling 100 points.
Regarding balance in the seated position, a score of 12 is considered when the patient needs to lean on something to maintain the position, and 0 when they are unable to maintain the posture (COLLIN; WADE, 1990).
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Day 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Functional Assesment
大体时间：6 months
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The CPAx measures physical morbidity in the intensive care population, reflecting the functional capacity of these individuals, divided into 10 commonly assessed physical ability components, each graded on a six-point Guttman scale, from complete dependence to independence.
It comprises assessments of: respiratory function, cough, bed mobility, transition from supine to sitting, dynamics of the sitting position, balance while standing, transition from sitting to standing, transfer from bed to chair, stepping, and handgrip strength.
The higher the score, the greater the patient's functional capacity.
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6 months
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Length of stay in the ICU
大体时间：28-day interval.
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Number of days the patient is hospitalized in the ICU.
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28-day interval.
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Diaphragmatic thickness
大体时间：Day 1
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Diaphragmatic thickness and excursion measurements will be collected at two times: before the first SBL and after physiotherapy treatment in both groups, in which the patient must be positioned in dorsal decubitus with the head elevated at an angle between 30° and 45° for both assessments.
The assessment of diaphragmatic thickness will be performed through the right hemidiaphragm using a linear transducer, in B-mode, positioned perpendicular to the rib cage, between the 8th and 9th intercostal spaces, on the anterior axillary line and mid-axillary line.
The muscle apposition zone will be observed, 0.5 to 2 cm below the costophrenic angle, and the image will be captured between two acoustic windows below the apposition zone.
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Day 1
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Diaphragmatic excursion
大体时间：Day 1
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Diaphragmatic excursion measurements will be collected at two times: before the first SBL and after physiotherapy treatment in both groups, in which the patient must be positioned in dorsal decubitus with the head elevated at an angle between 30° and 45° for both assessments.
The assessment of diaphragmatic mobility, a convex transducer (2.0-5.5 MHz) will be used in M-mode, positioned in the anterior subcostal region on the right between the midclavicular and anterior axillary lines.
The reference value for mobility is 1 to 2 cm.
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Day 1
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年4月29日
首先提交符合 QC 标准的
2026年5月7日
首次发布 (实际的)
2026年5月13日
研究记录更新
最后更新发布 (实际的)
2026年5月22日
上次提交的符合 QC 标准的更新
2026年5月18日
最后验证
2026年5月1日
更多信息
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