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

18 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

58

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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;

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: Standard physiotherapy
This group will undergo conventional physiotherapy according to institutional protocol.
Sperimentale: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Trunk Control
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional Assesment
Lasso di tempo: 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
Lasso di tempo: 28-day interval.
Number of days the patient is hospitalized in the ICU.
28-day interval.
Diaphragmatic thickness
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidade Federal do Rio de Janeiro

Collaboratori

Hospital Universitario Pedro Ernesto

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

13 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PNF 100685

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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