Development of an Exoskeleton for Patients' Mobility.

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Exoskeleton of default mode; Device: Exoskeleton of Intelligent mode

• Registration Number: NCT06513390
• Lead Sponsor: Vidyasirimedhi Institute of Science & Technology (VISTEC)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2022-07-12
• Study Completion: 2022-07-12
• Status Verified: 2024-07
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
healthys received intelligent mode first	Exoskeleton of default mode	healthy subjects received exoskeleton with intelligent mode first
healthys received default mode first	Exoskeleton of default mode	healthy subjects received exoskeleton with intelligent mode first
healthys received intelligent mode first	Exoskeleton of Intelligent mode	healthy subjects received exoskeleton with intelligent mode first
healthys received default mode first	Exoskeleton of Intelligent mode	healthy subjects received exoskeleton with intelligent mode first

Primary Outcome Measures

Name	Time	Method
gait kinematic of pelvic hip, knee and ankle joint.	1 day	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).

Secondary Outcome Measures

Name	Time	Method
Temporal spatial data of stance phase and swing phase time	1 day	Mean percentage of stance phase and swing phase time were collected by an eight-camera Motion analysis (Motion Analysis Corporation, Santa Rosa, CA, USA).
Muscle activity	1 day	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
Temporal spatial data of velocity	1 day	Mean velocity (m/s) was collected by an eight-camera Motion analysis (Motion Analysis Corporation, Santa Rosa, CA, USA).
Temporal spatial data of cadence	1 day	Mean cadence (step/min) was collected by an eight-camera Motion analysis (Motion Analysis Corporation, Santa Rosa, CA, USA).
Temporal spatial data of step length, step width, and stride length	1 day	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).
Oxygen consumption	1 day	VO2 MAX (ml/kg/min) was estimated for the walking trial.
user comfort scores	1 day	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.
exoskeleton performance scores	1 day	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).

Trial Locations

Locations (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand