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

18. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

58

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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;

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Annen: Standard physiotherapy
This group will undergo conventional physiotherapy according to institutional protocol.
Eksperimentell: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Trunk Control
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Functional Assesment
Tidsramme: 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
Tidsramme: 28-day interval.
Number of days the patient is hospitalized in the ICU.
28-day interval.
Diaphragmatic thickness
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Sponsor

Universidade Federal do Rio de Janeiro

Samarbeidspartnere

Hospital Universitario Pedro Ernesto

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

29. april 2026

Først innsendt som oppfylte QC-kriteriene

7. mai 2026

Først lagt ut (Faktiske)

13. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PNF 100685

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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