Critical IllnessPhase 1/2HEARTNCT07220733
Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial
A Phase 1/2 study testing Self-balancing robotic exoskeleton (Atalante X) in people with Critical Illness and Post Operative Complication, run by Wandercraft at 1 site in United States.
Trial summary
Patients admitted to the Intensive Care Unit (ICU) after thoracic surgery often experience complications related to immobility, such as muscle weakness, pulmonary issues, and longer recovery times. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Post Operative Complication, Thoracic Surgery
- What is being tested?
- Self-balancing robotic exoskeleton (Atalante X)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Feb 2026
- Phase
- Phase 1/2
- 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
- Above age of 18 years old,
- Having undergone thoracic surgery that necessitated admission in the TSICU.
- Debilitated as defined as a JH-HLM score of 5 or less
Who cannot join
- Height < 6'3 feet or weight > 220 lbs restrictions
- Severe muscular spasticity of the lower extremities (Modified Ashworth Scale Grade 3 higher).
- Current fractures or incomplete bone junctions in the spine, pelvis, and/or lower extremities
- Osteoporosis or lower bone mineral density -3.5, and history(ies) of osteoporotic fracture(s).
- Skin disorders including Stage I pressure injuries at the hip, lower limbs, and Exoskeleton contact areas, according to the National and European Pressure Ulcer Classification System (NPUAP-EPUAP).
- Severe arthritis, acute arthritis, or synovitis after total or partial lower limb joint replacement.
Show all 25Show fewer
- Myocardial infarction or angina or ischemic heart disease within the last 6 months.
- Uncorrectable leg length discrepancy over 2 cm when using additional correction tools.
- III-IV spine scoliotic deformity.
- Amputations and lower limb prostheses.
- Pregnancy
- Adults who lack the capacity to provide informed consent
- Cardiovascular instability as indicated by:
- Presence of unstable ventricular or atrial arrhythmias
- HR < 40 or HR > 140
- Lactate > 4.0 mmol/L
- On moderate-high dose vasopressors/inotropes
- Currently on VA ECMO
- Respiratory instability as indicated by:
- FiO2 > 0.6
- PEEP > 12 cm H2O
- RR > 35 bpm
- Currently on VV-ECMO
- Unable to follow commands
- Has bed rest orders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Patients admitted to the Intensive Care Unit (ICU) after thoracic surgery often experience complications related to immobility, such as muscle weakness, pulmonary issues, and longer recovery times. Early mobilization has been shown to improve outcomes, but its implementation is often limited by patient fragility and staff resources.
This study will test the safety and feasibility of using the Atalante X, a self-balancing exoskeleton, in the Thoracic Surgical ICU at Brigham and Women's Hospital. The exoskeleton is designed to support patients in standing and walking, even if they have limited strength or balance, thereby reducing the physical burden on healthcare staff and increasing patient mobility.
Read more
Eligible participants are adults recovering from thoracic surgery, who are debilitated (Johns Hopkins Highest Level of Mobility scale ≤ 5). Each participant will undergo up to 2-3 exoskeleton sessions per week for a maximum of 2 weeks. Sessions will be personalized, with progressive standing time and walking depending on patient tolerance.
The primary goal is to evaluate the safety of exoskeleton use, measured by adverse events such as skin lesions, cardiovascular instability, or accidental device-related issues.
The secondary goals are to evaluate:
Feasibility (ability to deliver sessions as planned, duration of standing/walking, level of assistance needed),
Usability (patient and staff satisfaction, ease of donning/doffing, staff workload), and
Preliminary effectiveness (improvement in mobility scores at discharge).
Results will provide early insights into whether robotic exoskeletons can be safely integrated into ICU rehabilitation programs after thoracic surgery.
Read the detailed description
Prolonged bed rest and immobility are common in ICU patients and are strongly associated with poor outcomes, including pulmonary complications, neuromuscular weakness, cognitive impairment, and delayed recovery. Early mobilization after thoracic surgery has been demonstrated to improve respiratory function, reduce complications, and shorten hospital stays. However, significant barriers remain, including patient instability, staffing limitations, and the complexity of mobilizing critically ill patients with multiple devices and lines.
The Atalante X exoskeleton (Wandercraft, Paris, France) is a self-balancing robotic device that enables hands-free standing and walking. Using advanced AI-based algorithms, it adjusts to patient needs and provides variable assistance. Previous clinical studies in populations with spinal cord injury and post-stroke hemiplegia have shown the device to be safe and feasible, with improvements in mobility and balance. Atalante X has obtained FDA clearance (product code PHL, Class II, 21 CFR 890.3480).
This pilot study, named HEART (Hyper Early Atalante Rehabilitation Therapy), is a prospective, single-arm, unicentric exploratory trial conducted in the Thoracic Surgical ICU at Brigham and Women's Hospital (Boston, MA).
Expected impact:
This study will provide critical early data on the integration of robotic exoskeletons into ICU rehabilitation. By supporting patient mobilization earlier and more safely, Atalante X has the potential to improve outcomes after thoracic surgery, reduce ICU length of stay, and enhance patient recovery trajectories.
- Being tested
- Self-balancing robotic exoskeleton (Atalante X)
- Keywords
- Thoracic Surgery, Postoperative Care, Atalante X Exoskeleton, Early Mobilisation, Intensive Care Unit (ICU)
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-balancing robotic exoskeleton (Atalante X)Device
This intervention consists of early mobilization sessions using the Atalante X, a self-balancing robotic exoskeleton (Wandercraft). Unlike other exoskeletons that require external support or crutches, this device is fully self-stabilizing and allows patients to stand and walk hands-free. It provides both passive and active modes, enabling short steps (EarlyGait) and longer steps (RealGait), with adjustable levels of assistance tailored to each patient's capacity. Sessions are performed 2-3 times per week for up to 2 weeks or until ICU discharge.
| Study group | Role | What they receive |
|---|---|---|
| Early mobilization with the Atalante X self-balancing exoskeleton | Experimental | The Atalante X self-balancing exoskeleton is designed to support patients. The device enables patients to stand upright safely, to perform short steps (EarlyGait) or longer steps (RealGait), and to walk either in passive mode (with full assistance) or in active mode (with partial assistance depending on patient capacity). Sessions are delivered 2 to 3 times per week for up to 2 weeks or until ICU discharge. Each session starts with standing and progressively increases in intensity, with parameters such as duration, number of steps, verticalization time, and assistance level recorded. Training is conducted by certified staff, with the primary objective of evaluating safety and feasibility, and secondary outcomes including usability and preliminary effectiveness. Receives: Device: Self-balancing robotic exoskeleton (Atalante X) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device- and procedure-related adverse events during exoskeleton use in ICU patients
Safety will be assessed by the rate and type of device- and procedure-related adverse events during exoskeleton use. This includes skin lesions, catheter dislodgement, hemodynamic instability, falls, or any serious adverse events (SAEs or SADEs). An acceptable rate is defined as <15% overall and <15% for skin lesions.
Measured: Baseline and through study completion, an average of 2 weeks
Secondary outcomes (12)
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Compliance Measure Description: Compliance (%) = (number of completed exoskeleton sessions ÷ number of expected sessions) × 100. Expected sessions are fixed at 2 per week during the ICU stay. Sessions beyond 2 per week count as completed sessions but do not increase the expected total.
Unit of Measure: percent (%)
Measured: At each training session through study completion (average of 2 weeks)
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Session Duration Measure Description: Duration of each exoskeleton session; mean duration per participant across all sessions.
Unit of Measure: minutes
Measured: At each training session through study completion (average of 2 weeks)
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Total Steps per Session Measure Description: Number of steps completed during each exoskeleton session; mean steps per participant across sessions.
Unit of Measure: steps
Measured: At each training session through study completion (average of 2 weeks)
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Duration by Walking Mode Measure Description: Time spent in each walking mode during exoskeleton sessions. EarlyGait and RealGait are reported separately; for each mode, the participant's mean duration across sessions is calculated.
Unit of Measure: minutes
Measured: At each training session through study completion (average of 2 weeks)
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Steps by Walking Mode Measure Description: Number of steps performed in each walking mode during exoskeleton sessions. EarlyGait and RealGait are reported separately; for each mode, the participant's mean steps across sessions is calculated.
Unit of Measure: steps
Measured: At each training session through study completion (average of 2 weeks)
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Lowest Assistance Level Achieved Measure Description: Lowest exoskeleton assistance (%) at which the participant completed ≥3 consecutive steps across all sessions.
Unit of Measure: percent (%)
Measured: At each training session through study completion (average of 2 weeks)
To evaluate the usability of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Donning and Doffing Time Measure Description: Time required to don and to doff the exoskeleton during each session. Donning and doffing are reported separately; for each, the participant's mean time across sessions is calculated.
Unit of Measure: minutes
Measured: At each training session through study completion (average of 2 weeks)
To evaluate the usability of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Satisfaction Score (Patient and Operator) Measure Description: Session-by-session satisfaction on a 0-10 numeric rating scale, reported by the patient and by the operator; mean per reporter (patient, operator) across sessions.
Unit of Measure: score (0-10)
Measured: At each training session through study completion (average of 2 weeks)
To evaluate the usability of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Operator Workload (NASA-TLX) Measure Description: Overall workload scored with NASA-TLX at the end of the protocol.
Unit of Measure: score (0-100)
Measured: At study completion (average of 2 weeks)
To evaluate the usability of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: System Usability Scale (SUS) Measure Description: Device usability scored with the System Usability Scale at the end of the protocol.
Unit of Measure: score (0-100)
Measured: At study completion (average of 2 weeks)
To evaluate the usability of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Operators per Session (overall and by qualification) Measure Description: Total number of operators involved per session (donning, doffing, and during training). Counts will also be reported by qualification category (PT, RN, physician, technician, other). For each participant, the mean count per session will be calculated overall and per category.
Unit of Measure: count and qualification
Measured: At each training session through study completion (average of 2 weeks)
To evaluate the effectiveness of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Functional Mobility (JH-HLM) Measure Description: Johns Hopkins Highest Level of Mobility score (1-8; higher = greater mobility), assessed per JH-HLM protocol.
Unit of Measure: score (1-8)
Measured: Baseline and at study completion (average of 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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 1/2
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, unicentric, exploratory pilot study. All participants will receive the intervention (Atalante X exoskeleton sessions) in addition to standard ICU care. There is no randomization or control group.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wandercraft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220733
- Sponsor's protocol ID
- CIP006
- Acronym
- HEART
- Status last verified
- Oct 2025
- First submitted
- 14 Oct 2025
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial
- ClinicalTrials.gov ID
- NCT07220733
- Acronym / sponsor ID
- HEART / CIP006
- Keywords
- Thoracic Surgery, Postoperative Care, Atalante X Exoskeleton, Early Mobilisation, Intensive Care Unit (ICU)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- WandercraftIndustry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 24 Oct 2025 (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.
Patients admitted to the Intensive Care Unit (ICU) after thoracic surgery often experience complications related to immobility, such as muscle weakness, pulmonary issues, and longer recovery times. Early mobilization has been shown to improve outcomes, but its implementation is often limited by patient fragility and staff resources.
This study will test the safety and feasibility of using the Atalante X, a self-balancing exoskeleton, in the Thoracic Surgical ICU at Brigham and Women's Hospital. The exoskeleton is designed to support patients in standing and walking, even if they have limited strength or balance, thereby reducing the physical burden on healthcare staff and increasing patient mobility.
Eligible participants are adults recovering from thoracic surgery, who are debilitated (Johns Hopkins Highest Level of Mobility scale ≤ 5). Each participant will undergo up to 2-3 exoskeleton sessions per week for a maximum of 2 weeks. Sessions will be personalized, with progressive standing time and walking depending on patient tolerance.
The primary goal is to evaluate the safety of exoskeleton use, measured by adverse events such as skin lesions, cardiovascular instability, or accidental device-related issues.
The secondary goals are to evaluate:
Feasibility (ability to deliver sessions as planned, duration of standing/walking, level of assistance needed),
Usability (patient and staff satisfaction, ease of donning/doffing, staff workload), and
Preliminary effectiveness (improvement in mobility scores at discharge).
Results will provide early insights into whether robotic exoskeletons can be safely integrated into ICU rehabilitation programs after thoracic surgery.
Detailed description
Prolonged bed rest and immobility are common in ICU patients and are strongly associated with poor outcomes, including pulmonary complications, neuromuscular weakness, cognitive impairment, and delayed recovery. Early mobilization after thoracic surgery has been demonstrated to improve respiratory function, reduce complications, and shorten hospital stays. However, significant barriers remain, including patient instability, staffing limitations, and the complexity of mobilizing critically ill patients with multiple devices and lines.
The Atalante X exoskeleton (Wandercraft, Paris, France) is a self-balancing robotic device that enables hands-free standing and walking. Using advanced AI-based algorithms, it adjusts to patient needs and provides variable assistance. Previous clinical studies in populations with spinal cord injury and post-stroke hemiplegia have shown the device to be safe and feasible, with improvements in mobility and balance. Atalante X has obtained FDA clearance (product code PHL, Class II, 21 CFR 890.3480).
This pilot study, named HEART (Hyper Early Atalante Rehabilitation Therapy), is a prospective, single-arm, unicentric exploratory trial conducted in the Thoracic Surgical ICU at Brigham and Women's Hospital (Boston, MA).
Expected impact:
This study will provide critical early data on the integration of robotic exoskeletons into ICU rehabilitation. By supporting patient mobilization earlier and more safely, Atalante X has the potential to improve outcomes after thoracic surgery, reduce ICU length of stay, and enhance patient recovery trajectories.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, unicentric, exploratory pilot study. All participants will receive the intervention (Atalante X exoskeleton sessions) in addition to standard ICU care. There is no randomization or control group.
| Arm | Type | Receives |
|---|---|---|
| Early mobilization with the Atalante X self-balancing exoskeleton | Experimental | Device: Self-balancing robotic exoskeleton (Atalante X)The Atalante X self-balancing exoskeleton is designed to support patients. The device enables patients to stand upright safely, to perform short steps (EarlyGait) or longer steps (RealGait), and to walk either in passive mode (with full assistance) or in active mode (with partial assistance depending on patient capacity). Sessions are delivered 2 to 3 times per week for up to 2 weeks or until ICU discharge. Each session starts with standing and progressively increases in intensity, with parameters such as duration, number of steps, verticalization time, and assistance level recorded. Training is conducted by certified staff, with the primary objective of evaluating safety and feasibility, and secondary outcomes including usability and preliminary effectiveness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above age of 18 years old,
- Having undergone thoracic surgery that necessitated admission in the TSICU.
- Debilitated as defined as a JH-HLM score of 5 or less
Key exclusion criteria (25 listed)
- Height < 6'3 feet or weight > 220 lbs restrictions
- Severe muscular spasticity of the lower extremities (Modified Ashworth Scale Grade 3 higher).
- Current fractures or incomplete bone junctions in the spine, pelvis, and/or lower extremities
- Osteoporosis or lower bone mineral density -3.5, and history(ies) of osteoporotic fracture(s).
- Skin disorders including Stage I pressure injuries at the hip, lower limbs, and Exoskeleton contact areas, according to the National and European Pressure Ulcer Classification System (NPUAP-EPUAP).
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 |
|---|---|---|
| Self-balancing robotic exoskeleton (Atalante X)This intervention consists of early mobilization sessions using the Atalante X, a self-balancing robotic exoskeleton (Wandercraft). Unlike other exoskeletons that require external support or crutches, this device is fully self-stabilizing and allows patients to stand and walk hands-free. It provides both passive and active modes, enabling short steps (EarlyGait) and longer steps (RealGait), with adjustable levels of assistance tailored to each patient's capacity. Sessions are performed 2-3 times per week for up to 2 weeks or until ICU discharge. | Device | Early mobilization with the Atalante X self-balancing exoskeleton |
Primary outcome
Incidence of device- and procedure-related adverse events during exoskeleton use in ICU patients
Time frame: Baseline and through study completion, an average of 2 weeks
Safety will be assessed by the rate and type of device- and procedure-related adverse events during exoskeleton use. This includes skin lesions, catheter dislodgement, hemodynamic instability, falls, or any serious adverse events (SAEs or SADEs). An acceptable rate is defined as <15% overall and <15% for skin lesions.
12 secondary outcomes
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Time frame: At each training session through study completion (average of 2 weeks)
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Time frame: At each training session through study completion (average of 2 weeks)
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Time frame: At each training session through study completion (average of 2 weeks)
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Time frame: At each training session through study completion (average of 2 weeks)
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Time frame: At each training session through study completion (average of 2 weeks)
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Time frame: At each training session through study completion (average of 2 weeks)
To evaluate the usability of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Time frame: At each training session through study completion (average of 2 weeks)
To evaluate the usability of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Time frame: At each training session through study completion (average of 2 weeks)
To evaluate the usability of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Time frame: At study completion (average of 2 weeks)
To evaluate the usability of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Time frame: At study completion (average of 2 weeks)
To evaluate the usability of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Time frame: At each training session through study completion (average of 2 weeks)
To evaluate the effectiveness of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Time frame: Baseline and at study completion (average of 2 weeks)
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 24 Oct 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Self-balancing robotic exoskeleton (Atalante X) in people with Critical Illness and Post Operative Complication, run by Wandercraft at 1 site in United States.
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 3 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 24 Oct 2025. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Raghu Seethala (617-525-3150, RSEETHALA@BWH.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of device- and procedure-related adverse events during exoskeleton use in ICU patients (time frame: Baseline and through study completion, an average of 2 weeks). 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 24 Oct 2025.