A Digital Twin for Exoskeleton Pilot

NCT05650255 — Not applicable, Completed, 30 participants, National Taiwan University Hospital

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Registry	NCT05650255
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	30 (Actual)
Sponsor	National Taiwan University Hospital (Other)
Conditions	Human Intention, Exoskeletons
Interventions	A Digital Twin for Exoskeleton Pilot (Other)
Dates	start 2022-11-07, primary completion 2025-07-31, completion 2025-08-27, first posted 2022-12-14, last updated 2026-10-20
Locations	1 site in Taiwan

-Summary

Although exoskeletons have been studied for many years, actual products have been sold on the market. However, there are still many limitations in the practical application of exoskeletons, and the control logic is also limited to the level of motor torque compensation, and lacks the consideration of overall motion stability (such as whether the wearer (driving, pilot) will fall). The purpose of this project is to establish a digital twin of this driving, which will perform the driving action in parallel, and calculate in parallel in the virtual environment the torque required to provide each joint torque to maintain stable walking without falling, and this torque can be used as a monitoring basis for the auxiliary torque of each axis for the exoskeleton. When the exoskeleton's movements are out of range of a stable gait, the controller can warn and attenuate the output of auxiliary forces, and on the other hand, it has the opportunity to analyze whether the intention of driving is to switch the movement mode - such as stopping, or sitting, squatting, etc.

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+Detailed description

This project is expected to use different machine learning models to make accurate predictions of human intent when healthy people drive different actions or action transitions of common human actions. Drivers will wear sensors such as inertial measurement unit (IMU) and electromyography (EMG) in the lower limbs to measure body signals of participants during actions in a non-invasive way, and let the system calculate the joint angle, angular velocity and angular acceleration of each joint of the driving lower limb related human signals.

+Arms and interventions

Arm	Type	Interventions	Description
A Digital Twin for Exoskeleton Pilot	Experimental	Other: A Digital Twin for Exoskeleton Pilot	This project is expected to use different machine learning models to make accurate predictions of human intent when healthy people drive different actions or action transitions of common human actions. Drivers will wear sensors such as inertial measurement unit (IMU) and electromyography (EMG) in the lower limbs to measure body signals of participants during actions in a non-invasive way, and let the system calculate the joint angle, angular velocity and angular acceleration of each joint of the driving lower limb related human signals.

A Digital Twin for Exoskeleton Pilot (Other): The purpose of this project is to establish a digital twin of this driving, which will perform the driving action in parallel, and calculate in parallel in the virtual environment the torque required to provide each joint torque to maintain stable walking without falling, and this torque can be used as a monitoring basis for the auxiliary torque of each axis for the exoskeleton. When the exoskeleton's movements are out of range of a stable gait, the controller can warn and attenuate the output of auxiliary forces, and on the other hand, it has the opportunity to analyze whether the intention of driving is to switch the movement mode - such as stopping, or sitting, squatting, etc.

+Outcome measures

Primary outcomes

The angles of the subject's joints. [3 years]: The angles of the subject's joints (unit: degree) are performed by using IMU sensors when subjects do some action such as standing, walking or sitting.
The activities of muscles state of human movement. [3 years]: The activities of muscles state of human movement (unit: millivolt or %) are performed by using EMG sensors when subjects do some action such as standing, walking, sitting, squatting or step-up.
The comprehensive intention of the subjects. [3 years]: The comprehensive intention time of the human body (unit: second) is performed by using IMU sensors and EMG sensors when subjects do some action such as standing, walking, sitting, squatting or step-up.

+Eligibility

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

Inclusion Criteria:

1. Can stand independently and walk for more than 5 minutes.
2. According to age, it can be divided into: elderly groups (aged between 50\~80 years old); Young people (aged 18\~50 years).

Exclusion Criteria:

1. Have current or previous neurological diseases of the lower extremities, such as: acute neuritis, stroke, Parkinson's disease.
2. Have current or previous orthopedic diseases of the lower extremities, such as: knee replacement, rheumatoid arthritis, or sports injuries and other symptoms.

+Locations (1)

Facility	City	Country	Status
National Taiwan University Hospital	Taipei,Taiwan	Taiwan

+Investigators

Wei-Li Hsu, Ph.D, Study director, Study Principal Investigator National Taiwan Unversity