Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial

NCT ID: NCT07220733

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-02-28

Brief 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. 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.

Conditions

Critical Illness; Post Operative Complication; Thoracic Surgery

Keywords

Thoracic Surgery; Postoperative Care; Atalante X Exoskeleton; Early Mobilisation; Intensive Care Unit (ICU)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Early mobilization with the Atalante X self-balancing exoskeleton

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.

Group Type: EXPERIMENTAL

Self-balancing robotic exoskeleton (Atalante X)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wandercraft

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Raghu Seethala

Role: CONTACT

Phone: 617-525-3150

Email: RSEETHALA@BWH.HARVARD.EDU

Stephanie KORLE

Role: CONTACT

Phone: 918-772-0845

Email: skorle@mgb.org

Other Identifiers

CIP006

Identifier Type: -

Identifier Source: org_study_id