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Completed

NCT Number: NCT06513390

Development of an Exoskeleton for 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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exoskeleton of default mode

Device

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

Exoskeleton of Intelligent mode

Device

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Temporal spatial data of velocity

    Time frame: 1 day

    Mean velocity (m/s) was collected by an eight-camera Motion analysis (Motion Analysis Corporation, Santa Rosa, CA, USA).

  2. Temporal spatial data of cadence

    Time frame: 1 day

    Mean cadence (step/min) was collected by an eight-camera Motion analysis (Motion Analysis Corporation, Santa Rosa, CA, USA).

  3. Temporal spatial data of step length, step width, and stride length

    Time frame: 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).

  4. Temporal spatial data of stance phase and swing phase time

    Time frame: 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).

  5. Muscle activity

    Time frame: 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

  6. Oxygen consumption

    Time frame: 1 day

    VO2 MAX (ml/kg/min) was estimated for the walking trial.

  7. user comfort scores

    Time frame: 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.

  8. exoskeleton performance scores

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Vidyasirimedhi Institute of Science & Technology (VISTEC)

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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