Neuromuscular Disease in Post-Intensive Care SyndromeExoReaNCT07907237
Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
A study testing rehabilitation session assisted by an exoskeleton in people with Neuromuscular Disease in Post-Intensive Care Syndrome, run by CHU de Reims.
Trial summary
The purpose of this study is to evaluate the feasibility of using a lower-limb exoskeleton in the intensive care unit for early mobilization of participants with intensive care neuromyopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Disease in Post-Intensive Care Syndrome
- What is being tested?
- rehabilitation session assisted by an exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Over 18 years of age
- Hospitalized in an intensive care unit
- Participants who have experienced organ failure requiring organ support (invasive mechanical ventilation, vasopressor amines, continuous renal replacement therapy, veno-venous or arteriovenous extracorporeal circulation), regardless of the duration of such support.
- Participants eligible for daily physical therapy
- Confirmed muscle weakness (MRC score strictly below 48/60)
- Able to sit on the edge of the bed without support
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- Unable to walk independently
- Have provided written consent
- Enrolled in a social security program
Who cannot join
- Hemodynamic instability requiring the use of vasopressor amines
- Respiratory failure requiring continuous support
- Impaired consciousness, confusion, or a neurological condition that prevents compliance with treatment
- Orthostatic hypotension
- Skin lesion at the device site
- Perineal skin lesion
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- Participants under legal guardianship
- Lower limb amputation
- Pregnant women
- Participation in another interventional study involving nutrition or rehabilitation
- Weight greater than 100 kg
- Height > 195 cm
- Hip flexion greater than 20°
- Knee flexion greater than 20°
- Inability to achieve 0° passive dorsiflexion of the ankle
- Spasticity > 3 on the Ashworth scale
- Orthostatic hypotension upon standing
- Poor tolerance of the orthosis (hemodynamic issues, skin lesions, etc.)
- Hip flexion greater than 20°
- Knee flexion greater than 20°
- Passive ankle dorsiflexion at 0° impossible
- Spasticity > 3 on the Ashworth scale
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to evaluate the feasibility of using a lower-limb exoskeleton in the intensive care unit for early mobilization of participants with intensive care neuromyopathy.
Read the detailed description
The participants' initial intensive care management will not be altered by the study. The study will begin at the end of their treatment, once organ failure has resolved and organ support has been discontinued. Participants with muscle weakness following intensive care will be eligible for exoskeleton-assisted rehabilitation sessions. In addition to their usual rehabilitation, participants will undergo a rehabilitation session lasting up to one hour, supervised by a physical therapist trained in the use of the exoskeleton.
The primary objective of the study is to assess feasibility based on the number of participants enrolled, the number of complete sessions completed, and the number of sessions per week. It also aims to assess technical feasibility by measuring the time required for setup and the number of staff needed to position the patient.
The secondary objectives focus on participant acceptability, safety, and efficacy by measuring the exoskeleton's impact on the incidence of PICS.
- Being tested
- rehabilitation session assisted by an exoskeleton
- Keywords
- Post-Intensive Care Syndrome (PICS), Exoskeleton, Intensive care unit (ICU), Critical Illness Myopathy
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation session assisted by an exoskeletonDevice
In this single arm, participants will be offered a rehabilitation session assisted by an exoskeleton. The session will consist of resuming walking under the supervision of a physical therapist. The duration of the session will be determined by the participant's perceived fatigue and will last a maximum of one hour if not limited by fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton-Assisted Rehabilitation | Experimental | Daily exoskeleton-assisted rehabilitation for participants with resuscitation-associated neuromyopathy Receives: Device: rehabilitation session assisted by an exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Exoskeleton-Assisted Rehabilitation
Eligibility rate, defined as the number of eligible participants relative to the number of patients in the ICU
Measured: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Enrollment rate, defined as the number of participants enrolled in the study relative to the number of eligible patients
Measured: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Initiation rate, defined as the number of included participants who complete at least one session
Measured: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Number of completed sessions
Measured: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Setup and session duration
Measured: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Rate of completed sessions relative to the number of scheduled sessions
Measured: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Technical failure rate (malfunction, calibration difficulties, anatomical incompatibility)
Measured: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Reasons for session termination
Measured: Up to 14 days
Secondary outcomes (15)
Patient acceptability
number of initial refusals
Measured: Up to 14 days
Patient acceptability
the dropout rate
Measured: Up to 14 days
Participant satisfaction levels
mean Visual Analogue Scale (VAS) score
Measured: Up to 14 days
Perceived effort during each session
mean Visual Analogue Scale (VAS) score
Measured: Up to 14 days
Acceptability from the team's perspective
Mean NASA-TLX Load Index score
Measured: Up to 14 days
Safety
Rate of serious adverse events
Measured: Up to 14 days
Safety
Rate of non-serious adverse events
Measured: Up to 14 days
Discontinuation criteria
Observed discontinuation criteria, n (%)
Measured: Up to 14 days
Efficacy (muscle function during treatment)
Assessment of muscle function during treatment: changes in walking time
Measured: Baseline and 1 month
Efficacy (muscle function during treatment)
session duration at the beginning and end of treatment
Measured: Baseline and 1 month
Efficacy
Number of squats performed per session
Measured: Baseline and 1 month
Efficacy
Average percentage of exoskeleton assistance per session and per leg
Measured: Baseline and 1 month
Efficacy
Minimum percentage of exoskeleton assistance per session
Measured: Baseline and 1 month
Efficacy
Medium-term impact on functional recovery as measured by the MRC score
Measured: Baseline and 1 month
Efficacy
Medium-term impact on functional recovery as measured by the Handgrip Strength test
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Disease in Post-Intensive Care SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907237
- Sponsor's protocol ID
- PO26066*
- Other IDs
- 2026-A00524-47
- Acronym
- ExoRea
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07907237
- Acronym / sponsor ID
- ExoRea / PO26066*
- Keywords
- Post-Intensive Care Syndrome (PICS), Exoskeleton, Intensive care unit (ICU), Critical Illness Myopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 30 Oct 2026 (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.
The purpose of this study is to evaluate the feasibility of using a lower-limb exoskeleton in the intensive care unit for early mobilization of participants with intensive care neuromyopathy.
Detailed description
The participants' initial intensive care management will not be altered by the study. The study will begin at the end of their treatment, once organ failure has resolved and organ support has been discontinued. Participants with muscle weakness following intensive care will be eligible for exoskeleton-assisted rehabilitation sessions. In addition to their usual rehabilitation, participants will undergo a rehabilitation session lasting up to one hour, supervised by a physical therapist trained in the use of the exoskeleton.
The primary objective of the study is to assess feasibility based on the number of participants enrolled, the number of complete sessions completed, and the number of sessions per week. It also aims to assess technical feasibility by measuring the time required for setup and the number of staff needed to position the patient.
The secondary objectives focus on participant acceptability, safety, and efficacy by measuring the exoskeleton's impact on the incidence of PICS.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton-Assisted Rehabilitation | Experimental | Device: rehabilitation session assisted by an exoskeletonDaily exoskeleton-assisted rehabilitation for participants with resuscitation-associated neuromyopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Over 18 years of age
- Hospitalized in an intensive care unit
- Participants who have experienced organ failure requiring organ support (invasive mechanical ventilation, vasopressor amines, continuous renal replacement therapy, veno-venous or arteriovenous extracorporeal circulation), regardless of the duration of such support.
- Participants eligible for daily physical therapy
- Confirmed muscle weakness (MRC score strictly below 48/60)
Key exclusion criteria (22 listed)
- Hemodynamic instability requiring the use of vasopressor amines
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 |
|---|---|---|
| rehabilitation session assisted by an exoskeletonIn this single arm, participants will be offered a rehabilitation session assisted by an exoskeleton. The session will consist of resuming walking under the supervision of a physical therapist. The duration of the session will be determined by the participant's perceived fatigue and will last a maximum of one hour if not limited by fatigue. | Device | Exoskeleton-Assisted Rehabilitation |
Primary outcome
Feasibility of Exoskeleton-Assisted Rehabilitation
Time frame: Up to 14 days
Eligibility rate, defined as the number of eligible participants relative to the number of patients in the ICU
Feasibility of Exoskeleton-Assisted Rehabilitation
Time frame: Up to 14 days
Enrollment rate, defined as the number of participants enrolled in the study relative to the number of eligible patients
Feasibility of Exoskeleton-Assisted Rehabilitation
Time frame: Up to 14 days
Initiation rate, defined as the number of included participants who complete at least one session
Feasibility of Exoskeleton-Assisted Rehabilitation
Time frame: Up to 14 days
Number of completed sessions
Feasibility of Exoskeleton-Assisted Rehabilitation
Time frame: Up to 14 days
Setup and session duration
Feasibility of Exoskeleton-Assisted Rehabilitation
Time frame: Up to 14 days
Rate of completed sessions relative to the number of scheduled sessions
Feasibility of Exoskeleton-Assisted Rehabilitation
Time frame: Up to 14 days
Technical failure rate (malfunction, calibration difficulties, anatomical incompatibility)
Feasibility of Exoskeleton-Assisted Rehabilitation
Time frame: Up to 14 days
Reasons for session termination
15 secondary outcomes
Patient acceptability
Time frame: Up to 14 days
Patient acceptability
Time frame: Up to 14 days
Participant satisfaction levels
Time frame: Up to 14 days
Perceived effort during each session
Time frame: Up to 14 days
Acceptability from the team's perspective
Time frame: Up to 14 days
Safety
Time frame: Up to 14 days
Safety
Time frame: Up to 14 days
Discontinuation criteria
Time frame: Up to 14 days
Efficacy (muscle function during treatment)
Time frame: Baseline and 1 month
Efficacy (muscle function during treatment)
Time frame: Baseline and 1 month
Efficacy
Time frame: Baseline and 1 month
Efficacy
Time frame: Baseline and 1 month
Efficacy
Time frame: Baseline and 1 month
Efficacy
Time frame: Baseline and 1 month
Efficacy
Time frame: Baseline and 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Recruiting
Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS)
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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.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation session assisted by an exoskeleton in people with Neuromuscular Disease in Post-Intensive Care Syndrome, run by CHU de Reims.
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 9 inclusion and 22 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mourvillier Bruno (+310736790 ext. 00 33, bmourvillier@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Exoskeleton-Assisted Rehabilitation (time frame: Up to 14 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.