Self-Balancing Exoskeleton for Postoperative Complications After Thoracic Surgery

(HEART Trial)

Overseen By Stephanie KORLE

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Wandercraft

Must not be taking: Vasopressors, Inotropes

Disqualifiers: Severe spasticity, Osteoporosis, Cardiovascular, Respiratory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Atalante X, a self-balancing exoskeleton, can safely assist patients in recovering after thoracic surgery. Designed to support those who struggle to stand or walk independently, it seeks to enhance mobility and reduce recovery time. Participants should be adults recovering from thoracic surgery who have difficulty moving. The trial will assess the exoskeleton's safety, ease of use, and effectiveness in aiding recovery. Results will help determine if exoskeletons can become part of future ICU rehabilitation. As a Phase 1, Phase 2 trial, this research focuses on understanding the exoskeleton's function in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in post-surgical recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Atalante X exoskeleton is safe for ICU patients after thoracic surgery?

Research has shown that the Atalante X exoskeleton is being tested for safety in assisting patients with movement after chest surgery. Early studies are evaluating patient usability and potential issues, such as skin irritation, heart problems, or device malfunctions.

As this trial is in its initial stages, the primary focus is on the safety and usability of the exoskeleton for patients. Previous studies have not identified major safety concerns, which is promising. However, the complete safety profile remains unclear due to the early phase of testing. Participants will attend sessions 2-3 times a week, allowing researchers to gather more information on the exoskeleton's effects on patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Atalante X self-balancing exoskeleton is unique because it offers a novel way to assist patients after thoracic surgery by enabling them to stand and walk safely with either full or partial assistance. Unlike traditional rehabilitation methods that may rely on physical therapists or assistive devices like walkers, this exoskeleton uses advanced technology to support early mobilization in a controlled manner. Researchers are excited because it can potentially enhance recovery by allowing patients to start moving sooner and more safely, which might reduce complications and improve overall outcomes. The exoskeleton also allows customizable training sessions that adapt to each patient's capabilities, providing a more personalized rehabilitation experience.

What evidence suggests that the Atalante X exoskeleton is effective for improving mobility after thoracic surgery?

Studies have shown that the Atalante X, a self-balancing exoskeleton, helps patients move more safely and sooner after chest surgery. In this trial, participants will use the Atalante X to assist with standing and walking, even with limited strength or balance. Research indicates that using the exoskeleton may improve recovery by increasing mobility scores upon hospital discharge. Initial findings suggest it also reduces the physical strain on healthcare staff. Overall, this innovative tool aims to make recovery after surgery more effective and manageable. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults in the ICU recovering from thoracic surgery who are weak (mobility scale ≤ 5). They'll try a robotic exoskeleton, Atalante X, to help them stand and walk. The goal is to see if it's safe and can be part of ICU rehab after such surgeries.

Inclusion Criteria

I am over 18 years old.

I had chest surgery that required a stay in the intensive care unit.

My health score is 5 or less, indicating I am quite weak.

Exclusion Criteria

Height < 6'3 feet or weight > 220 lbs restrictions

Pregnancy

Has bed rest orders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants undergo exoskeleton sessions 2-3 times per week for up to 2 weeks, focusing on standing and walking with the Atalante X device.

2 weeks

2-3 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of mobility scores.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Self-balancing robotic exoskeleton (Atalante X)

Trial Overview The Atalante X self-balancing exoskeleton is being tested for its safety and ability to help patients in the Thoracic Surgical ICU at Brigham and Women's Hospital. Patients will use it up to three times a week for two weeks, with sessions tailored to their strength.

How Is the Trial Designed?

Group I: Early mobilization with the Atalante X self-balancing exoskeleton Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Wandercraft

Lead Sponsor

Trials

10

Recruited

310+

Citations

1. trialx.com trialx.com/clinical-trials/listings/325293/safety-and-feasibility-of-a-self-balancing-exoskeleton-for-rehabilitation-in-the-thoracic-surgical-intensive-care-unit-a-pilot-trial/

Safety and Feasibility of a Self-Balancing Exoskeleton for ... By supporting patient mobilization earlier and more safely, Atalante X has the potential to improve outcomes after thoracic surgery, reduce ICU ...

2. medicaldevicenavigator.com medicaldevicenavigator.com/pilot_study_self_balancing_exoskeleton_thoracic_icus/

Pilot Study Explores Self-Balancing Exoskeleton in Thoracic ... This device offers an innovative solution for post-operative rehabilitation, targeting patients recovering from critical illness and surgical ...

3. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT07220733

Self-balancing robotic exoskeleton (Atalante X) in Critical ... Preliminary effectiveness (improvement in mobility scores at discharge). Results will provide early insights into whether robotic exoskeletons ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12431945/

The application of robotic and artificial intelligence ... Robotic-assisted systems enhance surgical precision and stability in procedures, such as pedicle screw placement, reducing error rates, and ...

5. researchgate.net researchgate.net/publication/392697419_ARTIFICIAL_INTELLIGENCE_IN_POSTOPERATIVE_REHABILITATION_PLANNING_A_SYSTEMATIC_REVIEW

artificial intelligence in postoperative rehabilitation planning Objective: This systematic review aims to assess the effectiveness and clinical outcomes of AI-assisted rehabilitation protocols compared to conventional ...

6. ctv.veeva.com ctv.veeva.com/study/safety-and-feasibility-of-a-self-balancing-exoskeleton-for-rehabilitation-in-the-thoracic-surgical-i

Safety and Feasibility of a Self-Balancing Exoskeleton for ... Expected impact: This study will provide critical early data on the integration of robotic exoskeletons into ICU rehabilitation. By supporting ...

7. meddatax.com meddatax.com/clinical-trials/NCT07220733

Safety and Feasibility of a Self-Balancing Exoskeleton for ... Prolonged bed rest and immobility are common in ICU patients and are strongly associated with poor outcomes, including pulmonary complications, neuromuscular ...