Development of an Exoskeleton for Patients' Mobility.

NCT ID: NCT06513390

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2022-07-12

Brief Summary

The goal of this clinical trial is to investigate the performance of a state-of-the-art adaptive CPG-based exoskeleton control system (intelligent mode) under a multi-metric analysis (involving three-dimensional gait analysis, muscle activity, oxygen consumption, user comfort, and exoskeleton performance scores) and comparing it to a standard commercial exoskeleton control system (default mode)

The main question it aims to answer is: Could the adaptive version improve natural walking and essential lower limb motions?

Participants will:

All participants were assigned into two groups to receive an alternate sequence of walking with the intelligent mode or the default mode of the lower-limb exoskeleton Exo-H3 at high and normal speed.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

healthys received intelligent mode first

healthy subjects received exoskeleton with intelligent mode first

Group Type: ACTIVE_COMPARATOR

Exoskeleton of default mode

Intervention Type: DEVICE

Default mode: A standard control system offering a conventional assistive function of Exo-H3.

Exoskeleton of Intelligent mode

Intervention Type: DEVICE

Intelligent mode: The adaptive CPG-based control system developed by our researchers from Exo-H3.

healthys received default mode first

healthy subjects received exoskeleton with intelligent mode first

Group Type: PLACEBO_COMPARATOR

Exoskeleton of default mode

Intervention Type: DEVICE

Default mode: A standard control system offering a conventional assistive function of Exo-H3.

Exoskeleton of Intelligent mode

Intervention Type: DEVICE

Intelligent mode: The adaptive CPG-based control system developed by our researchers from Exo-H3.

Interventions

Exoskeleton of default mode

Default mode: A standard control system offering a conventional assistive function of Exo-H3.

Intervention Type: DEVICE

Exoskeleton of Intelligent mode

Intelligent mode: The adaptive CPG-based control system developed by our researchers from Exo-H3.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• healthy Thai adults
• age between 18 and 60 years old
• body mass index between 18.5 and 24.9 kg/m2
• walk independently
• willing to participate in the study

Exclusion Criteria

• a history of surgery in the back, hip, knee, or ankle area
• previous injury or pain in the hip, knee, or ankle area that would affect walking patterns within the past 6 months
• a history of musculoskeletal or neuromuscular disease such as multiple sclerosis, myasthenia gravis
• a balance disorder
• unable to continue or withdrawal from the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vidyasirimedhi Institute of Science & Technology (VISTEC)

OTHER

Sponsor Role: lead

Responsible Party

Krongkaew Klaewkasikum

Faculty of Medicine, Ramathibodi Hospital, Mahidol University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

Grant No. I20POM-INT010

Identifier Type: -

Identifier Source: org_study_id