StrokeWalk-UpNCT04300491
Study Examines the Feasibility, Safety and Benefits of Using a Specific Suspension Walking Device for Patients With Neurological Damage
An observational study of Stroke and Traumatic Brain Injury, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Traumatic Brain Injury, Incomplete Cervical Spinal Cord Injury
- What is being tested?
- Suspension walking training
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2020to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Adults with Severe Neurological injury hospitalized in a unique Neuro-ICU from January 2018 to January 2019
Who may be able to join
- Adults
- Severe Neurological injury
- Hospitalization > 48h in a unique Neuro-ICU
- Necessity of mechanical ventilation
Who cannot join
- death before sedation weaning
- therapeutic limitation
- complete spinal cord injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Descriptive Study Focuses on 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).
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
- Conditions
- Stroke, Traumatic Brain Injury, Incomplete Cervical Spinal Cord Injury, Other Brain Injuries
- Being tested
- Suspension walking training
- Keywords
- Early mobilization, ICU, Brain injuries, Verticalization
- Medical subject headings
- Stroke, Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suspension walking trainingOther
Physiotherapy session, objective wlaking with body weight support using a specific device
| Study group | Role | What they receive |
|---|---|---|
| Beneficiaries of suspension walking | Not described Receives: Other: Suspension walking training | |
| Non-Beneficiaries of suspension walking | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Number of adverse events assessed immediately during walking sessions
Measured: 1 day
Secondary outcomes (4)
pre-post session changes in pulse
pre-post session changes in pulse assessed immediately during walking sessions
Measured: 1 day
oxygen saturation
oxygen saturation assessed immediately during walking sessions
Measured: 1 day
blood pressure
blood pressure assessed immediately during walking sessions
Measured: 1 day
Pain assessment
pain assessed immediately during walking sessions
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start30 Mar 2020
- Primary completion1 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- claire Jourdan, MD.PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300491
- Sponsor's protocol ID
- RECHMPL20_0129
- Acronym
- Walk-Up
- Status last verified
- Jun 2020
- First submitted
- 5 Mar 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Jourdan C, Pradalier F, Chalard K, Ascher M, Miron Duran F, Pavillard F, Greco F, Mellouk M, Fournier S, Djanikian F, Laffont I, Gelis A, Perrigault PF. Body-weight support gait training in neurological intensive care: safety, feasibility, and delays before walking with or without suspension. J Neuroeng Rehabil. 2023 Dec 13;20(1):167. doi: 10.1186/s12984-023-01291-9.
PubMed 38093374
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Descriptive Study Focuses on the Feasibility, Safety and Benefits of Using a Specific Suspension Walking Device for Patients With Neurological Damage
- ClinicalTrials.gov ID
- NCT04300491
- Acronym / sponsor ID
- Walk-Up / RECHMPL20_0129
- Conditions
- Stroke, Traumatic Brain Injury, Incomplete Cervical Spinal Cord Injury, Other Brain Injuries
- Keywords
- Early mobilization, ICU, Brain injuries, Verticalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beneficiaries of suspension walking | – | Other: Suspension walking training |
| Non-Beneficiaries of suspension walking | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Adults with Severe Neurological injury hospitalized in a unique Neuro-ICU from January 2018 to January 2019
Key inclusion criteria (4 listed)
- Adults
- Severe Neurological injury
- Hospitalization > 48h in a unique Neuro-ICU
- Necessity of mechanical ventilation
Key exclusion criteria (3 listed)
- death before sedation weaning
- therapeutic limitation
- complete spinal cord injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suspension walking trainingPhysiotherapy session, objective wlaking with body weight support using a specific device | Other | Beneficiaries of suspension walking |
Primary outcome
Number of adverse events
Time frame: 1 day
Number of adverse events assessed immediately during walking sessions
4 secondary outcomes
pre-post session changes in pulse
Time frame: 1 day
oxygen saturation
Time frame: 1 day
blood pressure
Time frame: 1 day
Pain assessment
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Derived from this study: PubMed 38093374Jourdan C, Pradalier F, Chalard K, Ascher M, Miron Duran F, Pavillard F, Greco F, Mellouk M, Fournier S, Djanikian F, Laffont I, Gelis A, Perrigault PF. Body-weight support gait training in neurological intensive care: safety, feasibility, and delays before walking with or without suspension. J Neuroeng Rehabil. 2023 Dec 13;20(1):167. doi: 10.1186/s12984-023-01291-9.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
claire Jourdan, MD.PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Traumatic Brain Injury, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04300491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.