Development of an Exoskeleton for Patients' Mobility.

Vidyasirimedhi Institute of Science & Technology (VISTEC)

Status: Completed

Conditions: Healthy

Treatments: Device: Exoskeleton of Intelligent mode; Device: Exoskeleton of default mode

Study type: Interventional

Funder types: Other

Identifiers

NCT06513390

Grant No. I20POM-INT010

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 2 patient groups, including a placebo group

healthys received intelligent mode first

Active Comparator group

Description:

healthy subjects received exoskeleton with intelligent mode first

Treatment:

Device: Exoskeleton of default mode

Device: Exoskeleton of Intelligent mode

healthys received default mode first

Placebo Comparator group

Description:

healthy subjects received exoskeleton with intelligent mode first

Treatment:

Device: Exoskeleton of default mode

Device: Exoskeleton of Intelligent mode