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CompletedNCT04300491Walk-UpUpdated Jun 5, 2020

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

An observational study in Stroke, Traumatic Brain Injury and Incomplete Cervical Spinal Cord Injury, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-05.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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

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Conditions studied

  • Stroke
  • Traumatic Brain Injury
  • Incomplete Cervical Spinal Cord Injury
  • Other Brain Injuries

Keywords

  • Early mobilization
  • ICU
  • Brain injuries
  • Verticalization
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All Adults with Severe Neurological injury hospitalized in a unique Neuro-ICU from January 2018 to January 2019

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • death before sedation weaning
  • therapeutic limitation
  • complete spinal cord injury
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Beneficiaries of suspension walking

    Other: Suspension walking training

  • Non-Beneficiaries of suspension walking

Interventions

  • OtherSuspension walking training

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

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What researchers measure

Primary outcomes

  1. Number of adverse events

    Number of adverse events assessed immediately during walking sessions

    Time frame: 1 day

Secondary outcomes

  1. pre-post session changes in pulse

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

    Time frame: 1 day

  2. oxygen saturation

    oxygen saturation assessed immediately during walking sessions

    Time frame: 1 day

  3. blood pressure

    blood pressure assessed immediately during walking sessions

    Time frame: 1 day

  4. Pain assessment

    pain assessed immediately during walking sessions

    Time frame: 1 day

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
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References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04300491
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Mar 9, 2020
Start date
Mar 30, 2020
Primary completion
Apr 1, 2020
Completion
Apr 30, 2020
Last update
Jun 5, 2020

Study contacts

claire Jourdan, MD.PhD
study director · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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