Development of an Exoskeleton for Patients' Mobility.

NCT06513390 | Completed

• 1 other identifier: Grant No. I20POM-INT010
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Exoskeleton; Gait; Kinematics; Temporal spatial; Muscle activity; Oxygen consumption

Outcome Measures

Primary Outcomes (1)

• gait kinematic of pelvic hip, knee and ankle joint.

  The average of pelvic-hip-knee-ankle angles (degrees) in frontal, sagittal and transverse plance were collected by using three dimensions with an eight-camera Motion analysis (Motion Analysis Corporation, Santa Rosa, CA, USA).

  1 day

Secondary Outcomes (8)

• Temporal spatial data of velocity

  1 day

• Temporal spatial data of cadence

  1 day

• Temporal spatial data of step length, step width, and stride length

  1 day

• Temporal spatial data of stance phase and swing phase time

  1 day

• Muscle activity

  1 day

Study Arms (2)

healthys received intelligent mode first

ACTIVE COMPARATOR

healthy subjects received exoskeleton with intelligent mode first

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

healthys received default mode first

PLACEBO COMPARATOR

healthy subjects received exoskeleton with intelligent mode first

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

Interventions

Exoskeleton of default mode DEVICE

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

healthys received default mode first; healthys received intelligent mode first

Exoskeleton of Intelligent mode DEVICE

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

healthys received default mode first; healthys received intelligent mode first

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vidyasirimedhi Institute of Science & Technology (VISTEC): lead

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Medicine, Ramathibodi Hospital, Mahidol University.

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 22, 2024
• Study Start: July 1, 2022
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)