Development of an Exoskeleton for Patients' Mobility.

The Development of an Exoskeleton System for Assisting and Enhancing Patients' Mobility.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Exoskeleton of default mode; Device: Exoskeleton of Intelligent mode

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Faculty of Medicine Ramathibodi Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: healthys received intelligent mode first; healthy subjects received exoskeleton with intelligent mode first	Device: Exoskeleton of default mode; Default mode: A standard control system offering a conventional assistive function of Exo-H3.; Device: Exoskeleton of Intelligent mode; Intelligent mode: The adaptive CPG-based control system developed by our researchers from Exo-H3.
Placebo Comparator: healthys received default mode first; healthy subjects received exoskeleton with intelligent mode first	Device: Exoskeleton of default mode; Default mode: A standard control system offering a conventional assistive function of Exo-H3.; Device: Exoskeleton of Intelligent mode; Intelligent mode: The adaptive CPG-based control system developed by our researchers from Exo-H3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporal spatial data of velocity	Mean velocity (m/s) was collected by an eight-camera Motion analysis (Motion Analysis Corporation, Santa Rosa, CA, USA).	1 day
Temporal spatial data of cadence	Mean cadence (step/min) was collected by an eight-camera Motion analysis (Motion Analysis Corporation, Santa Rosa, CA, USA).	1 day
Temporal spatial data of step length, step width, and stride length	Mean of step length(cm), step width(cm), and stride length(cm) were collected by an eight-camera Motion analysis (Motion Analysis Corporation, Santa Rosa, CA, USA).	1 day
Temporal spatial data of stance phase and swing phase time	Mean percentage of stance phase and swing phase time were collected by an eight-camera Motion analysis (Motion Analysis Corporation, Santa Rosa, CA, USA).	1 day
Muscle activity	Bilateral muscles activities of gluteus medius, gluteus maximus, tensor fascia latae, rectus femoris, bicep femoris, medial gastrocnemius, and tibialis anterior muscles during walking were quantified as root mean square (RMS) in the voltage	1 day
Oxygen consumption	VO2 MAX (ml/kg/min) was estimated for the walking trial.	1 day
user comfort scores	The wearer's opinion to the device, their perceived change, emotion on self-image, anxiety on security, harm or painful, attachment, and movement were evaluated as the comfort score. Each item rated from a 1 (the least problem) to 5 (the most problem). Sum of total score was 30, and categorized as very comfortable (1-6 points), comfortable (7-17 points), moderately comfortable (18 points), uncomfortable (19-29 points), and uncomfortable at all (30 points). The outcome was measured after completing the walk in each exoskeleton mode.	1 day
exoskeleton performance scores	The exoskeletal performance questionnaire comprised 2 domains; pain (walking, climbing stairs, rising from sitting, standing) and difficulty (descending stairs, ascending stairs, rising from sitting, standing, bending to floor, walking on even floor, walking for distance). Each item rated from 1 (minimal issues) to 5 (significant problems). The total performance score was designated as the best performance (1-11 points), good performance (12-13 points), moderate performance (33 point), poor performance (34-54 points), and the worst performance (55 points).	1 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): July 12, 2022
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Gait; Exoskeleton; Muscle activity; Kinematics; Oxygen consumption; Temporal spatial
• Other Study ID Numbers: Grant No. I20POM-INT010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No