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

Stroke Clinical Trial

— Walk-Up  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04300491
• Other study ID #: RECHMPL20_0129
• Status: Completed
• Start date: March 30, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 30, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Incomplete Cervical Spinal Cord Injury
• Other Brain Injuries
• Spinal Cord Injuries
• Stroke
• Trauma, Nervous System
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Suspension walking training
Physiotherapy session, objective wlaking with body weight support using a specific device

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	Number of adverse events assessed immediately during walking sessions	1 day
Secondary	pre-post session changes in pulse	pre-post session changes in pulse assessed immediately during walking sessions	1 day
Secondary	oxygen saturation	oxygen saturation assessed immediately during walking sessions	1 day
Secondary	blood pressure	blood pressure assessed immediately during walking sessions	1 day
Secondary	Pain assessment	pain assessed immediately during walking sessions	1 day