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Application of the Concept of Proprioceptive Neuromuscular Facilitation in Trunk Control in Patients Admitted to the ICU. (PNF)

18. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

58

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Brazílie
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazílie, 20551-030

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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;

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Jiný: Standard physiotherapy
This group will undergo conventional physiotherapy according to institutional protocol.
Experimentální: 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.
Jiný: Proprioceptive Neuromuscular Facilitation (PNF)
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Trunk Control
Časové okno: Day 1
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).
Day 1

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Functional Assesment
Časové okno: 6 months
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.
6 months
Length of stay in the ICU
Časové okno: 28-day interval.
Number of days the patient is hospitalized in the ICU.
28-day interval.
Diaphragmatic thickness
Časové okno: Day 1
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.
Day 1
Diaphragmatic excursion
Časové okno: Day 1
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.
Day 1

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Universidade Federal do Rio de Janeiro

Spolupracovníci

Hospital Universitario Pedro Ernesto

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

31. prosince 2028

Termíny zápisu do studia

První předloženo

29. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

7. května 2026

První zveřejněno (Aktuální)

13. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PNF 100685

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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