HealthyNCT06513390
Development of an Exoskeleton for Patients' Mobility.
A study testing Exoskeleton of default mode and Exoskeleton of Intelligent mode in people with Healthy, run by Vidyasirimedhi Institute of Science & Technology (VISTEC) at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exoskeleton of default mode and Exoskeleton of Intelligent mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2022to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, 10400
About this study
Official title: 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?
Read more
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
- Being tested
- Exoskeleton of default mode, Exoskeleton of Intelligent mode
- Keywords
- Exoskeleton, Gait, Kinematics, Temporal spatial, Muscle activity, Oxygen consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoskeleton of default modeDevice
Default mode: A standard control system offering a conventional assistive function of Exo-H3.
Exoskeleton of Intelligent modeDevice
Intelligent mode: The adaptive CPG-based control system developed by our researchers from Exo-H3.
| Study group | Role | What they receive |
|---|---|---|
| healthys received intelligent mode first | Active comparator | healthy subjects received exoskeleton with intelligent mode first Receives: 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 Receives: Device: Exoskeleton of default mode; Device: Exoskeleton of Intelligent mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (8)
Temporal spatial data of velocity
Mean velocity (m/s) was collected by an eight-camera Motion analysis (Motion Analysis Corporation, Santa Rosa, CA, USA).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 1 day
Oxygen consumption
VO2 MAX (ml/kg/min) was estimated for the walking trial.
Measured: 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.
Measured: 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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Jul 2022
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidyasirimedhi Institute of Science & Technology (VISTEC)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krongkaew Klaewkasikum, Vidyasirimedhi Institute of Science & Technology (VISTEC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513390
- Sponsor's protocol ID
- Grant No. I20POM-INT010
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Supapitanon K, Patathong T, Akkawutvanich C, Srisuchinnawong A, Ketrungsri W, Manoonpong P, Woratanarat P, Angsanuntsukh C. Comprehensive multi-metric analysis of user experience and performance in adaptive and non-adaptive lower-limb exoskeletons. PLoS One. 2025 Jan 9;20(1):e0313593. doi: 10.1371/journal.pone.0313593. eCollection 2025.
PubMed 39787128
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of an Exoskeleton System for Assisting and Enhancing Patients' Mobility.
- ClinicalTrials.gov ID
- NCT06513390
- Acronym / sponsor ID
- Grant No. I20POM-INT010
- Conditions
- Healthy
- Keywords
- Exoskeleton, Gait, Kinematics, Temporal spatial, Muscle activity, Oxygen consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Vidyasirimedhi Institute of Science & Technology (VISTEC)University, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthys received intelligent mode first | Active comparator | Device: Exoskeleton of default mode, Device: Exoskeleton of Intelligent modehealthy subjects received exoskeleton with intelligent mode first |
| healthys received default mode first | Placebo comparator | Device: Exoskeleton of default mode, Device: Exoskeleton of Intelligent modehealthy subjects received exoskeleton with intelligent mode first |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exoskeleton of default modeDefault mode: A standard control system offering a conventional assistive function of Exo-H3. | Device | healthys received default mode first, healthys received intelligent mode first |
| Exoskeleton of Intelligent modeIntelligent mode: The adaptive CPG-based control system developed by our researchers from Exo-H3. | Device | healthys received default mode first, healthys received intelligent mode first |
Primary outcome
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).
8 secondary outcomes
Temporal spatial data of velocity
Time frame: 1 day
Temporal spatial data of cadence
Time frame: 1 day
Temporal spatial data of step length, step width, and stride length
Time frame: 1 day
Temporal spatial data of stance phase and swing phase time
Time frame: 1 day
Muscle activity
Time frame: 1 day
Oxygen consumption
Time frame: 1 day
user comfort scores
Time frame: 1 day
exoskeleton performance scores
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Derived from this study: PubMed 39787128Supapitanon K, Patathong T, Akkawutvanich C, Srisuchinnawong A, Ketrungsri W, Manoonpong P, Woratanarat P, Angsanuntsukh C. Comprehensive multi-metric analysis of user experience and performance in adaptive and non-adaptive lower-limb exoskeletons. PLoS One. 2025 Jan 9;20(1):e0313593. doi: 10.1371/journal.pone.0313593. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton of default mode and Exoskeleton of Intelligent mode in people with Healthy, run by Vidyasirimedhi Institute of Science & Technology (VISTEC) at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait kinematic of pelvic hip, knee and ankle joint. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06513390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.