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NCT Number: NCT04300491

Study Examines the Feasibility, Safety and Benefits of Using a Specific Suspension Walking Device for Patients With Neurological Damage

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).

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults
  • Severe Neurological injury
  • Hospitalization > 48h in a unique Neuro-ICU
  • Necessity of mechanical ventilation

Exclusion criteria

  • death before sedation weaning
  • therapeutic limitation
  • complete spinal cord injury

Treatment and study plan

Suspension walking training

Other

Physiotherapy session, objective wlaking with body weight support using a specific device

Primary outcomes

  1. Number of adverse events

    Time frame: 1 day

    Number of adverse events assessed immediately during walking sessions

Secondary outcomes

  1. pre-post session changes in pulse

    Time frame: 1 day

    pre-post session changes in pulse assessed immediately during walking sessions

  2. oxygen saturation

    Time frame: 1 day

    oxygen saturation assessed immediately during walking sessions

  3. blood pressure

    Time frame: 1 day

    blood pressure assessed immediately during walking sessions

  4. Pain assessment

    Time frame: 1 day

    pain assessed immediately during walking sessions

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: Walk-Up

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2020
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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