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NCT Number: NCT05650255

A Digital Twin for Exoskeleton Pilot

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei,Taiwan, Taiwan

Location status: Recruiting

Location contact

Wei-Li Hsu, Ph.D

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. The angles of the subject's joints.

    Time frame: 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.

  2. The activities of muscles state of human movement.

    Time frame: 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.

  3. The comprehensive intention of the subjects.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei-Li Hsu, Ph.D

CONTACT

[email protected]

+886-2-3366-8127

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 14, 2022
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.