Clinical trial NCT05650255: A Digital Twin for Exoskeleton Pilot
Official title: A Digital Twin for Exoskeleton Pilot
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Intention
Exoskeletons
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The angles of the subject's joints.
timeFrame: 3 years
measure: The activities of muscles state of human movement.
timeFrame: 3 years
measure: The comprehensive intention of the subjects.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei,Taiwan
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Study Principal Investigator National Taiwan Unversity
name: Wei-Li Hsu, Ph.D
role: STUDY_DIRECTOR
References: