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Efficacy of Different Treatments for the Intensive Care Unit Acquired Weakness

NCT04613908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-11-03

No results posted yet for this study

Summary

Experimental study that has how to compare the efficacy between conventional rehabilitation, transcutaneous electrostimulation or early mobilization to reduce the time needed to reverse the muscle weakness evaluated by the muscle strength scale of the MRC in patients with a clinical diagnosis of intensive care unit acquired weakness in the (ICUAW).The ambit of realization is a medical-surgical ICU of a general acute hospital (26 beds). A randomized controlled, uni-centric design was used. The interventions are divided into three groups namely; group 1 (control group) receiving standard or usual rehabilitation (GR-STD); group 2 receives transcutaneous electrostimulation (GR-TEE) and group 3 that consists of an early mobilization protocol (GR-EM). The main outcome variable of the study is the time, in days and sessions of treatment, to reverse the ICUAW.

Conditions

  • Muscle Weakness
  • Rehabilitation

Interventions

DEVICE

neuro muscular electro stimulation

We used a commercial equipment of electro stimulation with a pulse width of 300 micro seconds, a frequency of 50 Hz, with symmetrical balanced biphasic rectangular wave and with an intensity of up to 80 milliampere.

OTHER

Early Mobilization protocol

The protocol consisted in applying a specific treatment based on different levels of treatment to each subject. Admission to them was carried out according to the maximum capacity of each subject, the conditions of each level being the following: * Level 1: MRC (shoulder) \<3 + MRC \<3 (hip). * Level 2: MRC (shoulder) ≥ 3 + MRC (hip) \<3. * Level 3: MRC (shoulder) ≥ 3 + MRC (hip) ≥ 3 + sitting on the edge of the bed without assistance (minimum 15 minutes). * Level 4: Standing without assistance and walking with or without assistance.

OTHER

standard care or usual rehabilitation

routine, non-protocolized rehabilitation treatment performed by the physiotherapist assigned to intensive care

Sponsors & Collaborators

  • Hospital Nacional Profesor Alejandro Posadas

    lead OTHER

Principal Investigators

  • Ladislao P Diaz Ballve · Hospital Nacional Posadas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2016-08-31
Completion
2016-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04613908 on ClinicalTrials.gov