Recruiting
Phase 1
Phase 2

Atalante X

Sponsor:

Wandercraft

Code:

NCT07220733

Conditions

Critical Illness

Post Operative Complication

Thoracic Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Self-balancing robotic exoskeleton (Atalante X)

Study Details

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

Study ID

NCT07220733

Start date

Oct, 2025

Status verified date

Oct, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: 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.

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.

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 ]

Central Contacts and Locations

Central contacts

Raghu Seethala

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

Stephanie KORLE

918-772-0845skorle@mgb.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Wandercraft

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wandercraft on 2025-10-24.