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Clinical Trials/NCT04300491
NCT04300491
Completed
Not Applicable

Monocentric Descriptive Study Focuses on the Feasibility, Safety and Benefits of Using a Specific Suspension Walking Device for Patients With Neurological Damage

University Hospital, Montpellier1 site in 1 country100 target enrollmentMarch 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University Hospital, Montpellier
Enrollment
100
Locations
1
Primary Endpoint
Number of adverse events
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This monocentric descriptive study addresses feasibility, safety and benefits of using a specific suspension walking device for patients with severe neurological injuries in the neuroICU of Montpellier University Hospital, France. Analyzes are retrospective on data collected prospectively during standard practice. All adult neurological patients hospitalized for > 48 hours and requiring mechanical ventilation from January 2018 to January 2019 are included, and divided into two groups: beneficiaries of suspension walking during the ICU stay, and non-beneficiaries. Characteristics of the two groups are compared and reasons for not using suspension walking recorded (feasibility). After pooling all suspension walking sessions, changes in clinical parameters during sessions and occurrence of adverse events are described (tolerance).

Detailed Description

Background. Current literature and National guidelines recommend early mobilization in Intensive Care Units (ICU), including verticalization and walking. Verticalization for neurologic patients in ICU is challenging because of neurological impairments, risks of falls and of clinical worsening. In the neuroICU of Montpellier university hospital, France, a weight suspension system (LiteGait®) is used for gait training. Objectives. To study the feasibility, safety and benefits of walking with the weight suspension system in a neuroICU. Feasibility involves the proportion of patients who benefited from suspension walking, reasons for not using it, physiotherapists' time required. Safety involves rate and causes of adverse events, changes in vital parameters and in pain. Benefits of suspension walking involves difference between delay for first suspension walking session and first walking session without suspension. Design. Monocentric, descriptive study, using retrospective analyzes of prospectively-collected data during standard clinical and rehabilitation management in the neuroICU. It includes all adult neurological patients hospitalized for \> 48 hours in the unit and requiring mechanical ventilation from January 2018 to January 2019. Exclusion criteria are death before sedation weaning; therapeutic limitation; complete spinal cord injury. The study sample is divided into two groups: beneficiaries of suspension walking during the ICU stay, and non-beneficiaries. Criteria for using suspension walking used in standard practice in the unit are respiratory stability without mechanical ventilation (tracheostomy and/or oxygen therapy possible), hemodynamic and neurologic stability, sufficient respond to command (head control, ability to sit with aid, testing of one quadriceps \> 3 or two quadriceps \> 2). Data collected include clinical description of patients upon ICU admission, duration of sedation, ventilation, hospitalization, and delay before first sitting on a chair, first walking without suspension. For beneficiaries of suspension walking, clinical status before session (pain, MRC testing, sitting balance, RASS, hemodynamic and respiratory parameters, medical equipment) and after session (pain, hemodynamic and respiratory parameters) are collected, as well as description of adverse events and consequences. For non-beneficiaries, reasons for not using suspension walking are collected. Analyses will be mainly descriptive. Characteristics of beneficiaries and non-beneficiaries of suspension walking will be described and compared. Description of suspensi

Registry
clinicaltrials.gov
Start Date
March 30, 2020
End Date
April 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of adverse events

Time Frame: 1 day

Number of adverse events assessed immediately during walking sessions

Secondary Outcomes

  • pre-post session changes in pulse(1 day)
  • blood pressure(1 day)
  • oxygen saturation(1 day)
  • Pain assessment(1 day)

Study Sites (1)

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