Skip to content

Early proprioceptive stimulations in mechanically ventilated critically ill patients

Assessment of the effects of early proprioceptive stimulations on the functional status of mechanically ventilated critically ill patients: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55173665
Enrollment
150
Registered
2023-03-14
Start date
2023-02-27
Completion date
Unknown
Last updated
2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early rehabilitation of critically ill patients Not Applicable

Interventions

The control group receives standard treatment usually provided in the ICU. The intervention group receives standard treatment, and in addition, they receive "functional proprioceptive

Sponsors

Association MAPAR (Mise Au Point Anesthésie Réanimation)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult (= 18 years old) 2. Hospitalised in the intensive care unit (ICU) 3. At least 48 hours of mechanical ventilation 4. Functionally independent two weeks before the admission to ICU (Barthel Index = 70, estimated by interviewing relatives)

Exclusion criteria

Exclusion criteria: 1. Hospitalised in ICU for more than 5 days 2. Hyperacute phase (absence of hemodynamic balance) 3. Orthopedic injury preventing the implementation of the protocol 4. Serious psychiatric or cognitive history 5. Irreversible disorder with a 6-month mortality greater than 50% or patient with a probable fatal outcome in the ICU 6. Rapidly progressive neuromuscular disease 7. Spinal cord injury 8. Severe traumatic brain injury (Glasgow Coma Scale score = 8) 10. Known pregnancy 11. Patients with phlebitis 12. Patients with active devices such as pacemakers, defibrillators, insulin pumps, neurostimulators, etc. 13. Patients with cardiac arrhythmia 14. Patients with epilepsy 15. Patients with fragile skin or open wounds 16. Not affiliated with the French social security system 17. Patients who speak neither French nor English 18. Persons deprived of liberty and under legal protection

Design outcomes

Primary

MeasureTime frame
Functional status measured using the Physical Function in ICU Test-scored (PFIT-s) at discharge from the ICU

Secondary

MeasureTime frame
1. Cognitive impairments measured using the Montreal cognitive assessment (MoCA) at discharge from the ICU and 3 months after discharge 2. Anxiety and depressive disorders measured using the Hospital anxiety and depression scale (HADS) at discharge from the ICU and 3 months after discharge 3. PTSD symptoms measured using the PTSD Checklist for DSM-5 (PCL-5) at discharge from the ICU and 3 months after discharge 4. Functional status measured using the Physical Function in ICU Test-scored (PFIT-s) 8 to 10 days from admission in the ICU and upon awakening 5. Functional status measured using the ICU Mobility Scale (IMS) upon awakening and on discharge from the ICU 6. Functional independence measured using the Barthel Index at discharge from the ICU and 3 months after discharge 7. Correlations between functional tests (PFIT-s, IMS, Barthel Index) and cognitive tests (MoCA, HAD, PCL-5) measured using Pearson or Spearman coefficients using the timepoints defined 8. Muscular strength measured using the Medical Research Council-Sum Score (MRC-SS) and with a dynamometric measure of the quadriceps strength upon awakening and then once a week until discharge from the ICU 9. Changes in the quadriceps muscle thickness measured using ultrasound at inclusion, at 4 days post-inclusion, at 10 days post-inclusion, and then once a week until discharge from the ICU 10. Changes in the rectus femoris cross-section measured using ultrasound at inclusion, at 4 days post-inclusion, at 10 days post-inclusion, and then once a week until discharge from the ICU 11. Changes in the rectus femoris echogenicity measured using ultrasound at inclusion, at 4 days post-inclusion, at 10 days post-inclusion, and then once a week until discharge from the ICU 12. Changes in the spasticity measured using the modified Ashworth scale (MA

Countries

France

Contacts

Public ContactBernard Vigué
bernard.vigue@aphp.fr+33145213430

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026