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NCT07220733 · ClinicalTrials.gov registry record · Phase 1
Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial
A Phase 1 study of Critical Illness and Thoracic Surgery, sponsored by Wandercraft.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT07220733: Recruiting Phase 1 study of Critical Illness and Thoracic Surgery, sponsored by Wandercraft.
NCT07220733 is a Phase 1 study of Critical Illness and Thoracic Surgery that is actively recruiting participants, run by Wandercraft. The registered enrollment target is 5 participants, below the 3,138-participant average among 91 other Critical Illness trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07220733, a Phase 1 study of Critical Illness and Thoracic Surgery, is actively recruiting participants, sponsored by Wandercraft.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Self-balancing robotic exoskeleton (Atalante X)
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2025-10 |
| Est. Completion | 2026-02 |
| Phase | Phase 1 |
What NCT07220733 shows while recruiting
NCT07220733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 3,138-participant average among 91 other Critical Illness trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Critical Illness appearing as the primary indexed condition, and to 1 intervention - of which Self-balancing robotic exoskeleton (Atalante X) is the first listed.
NCT07220733 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07220733 about?
NCT07220733 is a clinical study titled "Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial". 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 pati...
What is the current status of trial NCT07220733?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2025-10. Estimated completion is 2026-02.
What conditions does trial NCT07220733 study?
This clinical trial studies the following conditions: Critical Illness, Thoracic Surgery, Post Operative Complication.
What interventions are being tested in trial NCT07220733?
The interventions under investigation include: Self-balancing robotic exoskeleton (Atalante X) (DEVICE).
Who is sponsoring clinical trial NCT07220733?
This trial is sponsored by Wandercraft, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07220733 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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