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

NCT07220733 | Recruiting Phase 1 FDA Device

• 1 other identifier: CIP006
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Post Operative Complication; Thoracic Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  At each training session through study completion (average of 2 weeks)

Study Arms (1)

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.

Device: Self-balancing robotic exoskeleton (Atalante X)

Interventions

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.

Early mobilization with the Atalante X self-balancing exoskeleton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wandercraft: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Raghu Seethala

CONTACT

617-525-3150; RSEETHALA@BWH.HARVARD.EDU

Stephanie KORLE

CONTACT

918-772-0845; skorle@mgb.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 24, 2025
• Study Start: October 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (1)