An interventional study of rehabilitation session assisted by an exoskeleton in Neuromuscular Disease in Post-Intensive Care Syndrome, sponsored by CHU de Reims. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by CHU de Reims · Not applicable, Interventional, and Device feasibility
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.
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.
105 studies on the registry are indexed under postintensive care syndrome; 48 are open to participants now.
This study's planned enrollment of 30 is below the median of 78 across 47 interventional studies indexed under postintensive care syndrome.
Browse postintensive care syndrome studies →CHU de Reims is the lead sponsor of 276 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Hemodynamic instability requiring the use of vasopressor amines
Daily exoskeleton-assisted rehabilitation for participants with resuscitation-associated neuromyopathy
Device: rehabilitation session assisted by an exoskeleton
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.
Feasibility of Exoskeleton-Assisted Rehabilitation
Eligibility rate, defined as the number of eligible participants relative to the number of patients in the ICU
Time frame: 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
Time frame: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Initiation rate, defined as the number of included participants who complete at least one session
Time frame: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Number of completed sessions
Time frame: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Setup and session duration
Time frame: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Rate of completed sessions relative to the number of scheduled sessions
Time frame: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Technical failure rate (malfunction, calibration difficulties, anatomical incompatibility)
Time frame: Up to 14 days
Feasibility of Exoskeleton-Assisted Rehabilitation
Reasons for session termination
Time frame: Up to 14 days
Patient acceptability
number of initial refusals
Time frame: Up to 14 days
Patient acceptability
the dropout rate
Time frame: Up to 14 days
Participant satisfaction levels
mean Visual Analogue Scale (VAS) score
Time frame: Up to 14 days
Perceived effort during each session
mean Visual Analogue Scale (VAS) score
Time frame: Up to 14 days
Acceptability from the team's perspective
Mean NASA-TLX Load Index score
Time frame: Up to 14 days
Safety
Rate of serious adverse events
Time frame: Up to 14 days
Safety
Rate of non-serious adverse events
Time frame: Up to 14 days
Discontinuation criteria
Observed discontinuation criteria, n (%)
Time frame: Up to 14 days
Efficacy (muscle function during treatment)
Assessment of muscle function during treatment: changes in walking time
Time frame: Baseline and 1 month
Efficacy (muscle function during treatment)
session duration at the beginning and end of treatment
Time frame: Baseline and 1 month
Efficacy
Number of squats performed per session
Time frame: Baseline and 1 month
Efficacy
Average percentage of exoskeleton assistance per session and per leg
Time frame: Baseline and 1 month
Efficacy
Minimum percentage of exoskeleton assistance per session
Time frame: Baseline and 1 month
Efficacy
Medium-term impact on functional recovery as measured by the MRC score
Time frame: Baseline and 1 month
Efficacy
Medium-term impact on functional recovery as measured by the Handgrip Strength test
Time frame: Baseline and 1 month
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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