Development of an Exoskeleton for Patients' Mobility.
NCT Number: NCT06513390
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DEVICE: Exoskeleton of default mode|DEVICE: Exoskeleton of Intelligent mode
Sponsor: Vidyasirimedhi Institute of Science & Technology (VISTEC)
Sex: ALL
Age: ADULT
Enrollment: 8
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-07-01
Completion Date: 2022-07-12
Locations: Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand

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.

Primary Outcome Measures: 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: 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