BurnsNCT07277166
The Effect of Mobile Robot Assisted Gait Training on Gait Performance in Chronic Patients With Impaired Gait Function After Burn Injury
A study testing wearable robot training in people with Burns and Gait Dysfunction, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
Trial summary
This study aims to examine the clinical effectiveness of gait training using wearable robots in patients with impaired gait function after burn injury. The participants were chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Burns, Gait Dysfunction, Robot Training
- What is being tested?
- wearable robot training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 May 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait dysfunction 6 months later. -aged over 18 years
- had a Functional Ambulation Category (FAC) score of 3 or higher
Who cannot join
- fourth-degree burns (involving muscles, tendons, and bone injuries)
- severe communication disorders because of intellectual impairment and psychological problems
- Patients with body types that prevent them form wearing the robot, such as a height of 4.59 feet (140cm) or 5.91 feet (185cm) or more, or severe obesity with a BMI of 35 or more.
- Patients with heart and circulatory conditions that may affect gait training.
- Patients at a high risk of falling during gait training, owing to severe dizziness and having experienced a fall within the preceeding 2 month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Hangang sacred heart hodpital
Seoul, 07247
Ragyem Sung, 82-10-5939-2541, sung6652@hallym.or.kr
About this study
Official title: The Effect of Mobile Robot Assisted Gait Training on Gait Performance in Chronic Patients With Impaired Gait Function After Burn Injury : Pilot Study
This study aims to examine the clinical effectiveness of gait training using wearable robots in patients with impaired gait function after burn injury. The participants were chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait dysfunction 6 months later. Eligible participants were aged over 18 years and had a Functional Ambulation Category (FAC) score of 3 or higher. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. Assessments were carried out before and immediately after the 12-week training period. Physical ability were assessed using the functional ambulatory category(FAC) scale, the 6-Minute Walk Test (6MWT), and the visual analogue scale (VAS). Spatiotemporal gait parameters-including gait speed, cadence, and step length-and sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases were measured during gait analysis. Pulmonary function test such as forced vital capacity (FVC), 1-s forced expiratory volume (FEV1), and carbon monoxide (DLco). The highest maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) value were evaluated.
Read the detailed description
Regaining a mobility level post-surgery that comes close to the patient's previous mobility as a baseline is the goal. It is commonly accepted that conventional physiotherapy after burn injury has a positive impact on muscle strength, range of motion, pain or gait performance which all impact patient mobility. Wearable robots that assist walking centered on the hip joint of the lower extremities are appearing. This wearable robot is a positive effect in terms of increased energy efficiency and posture during walking. This study aims to examine the clinical effectiveness of gait training using wearable robots in patients with impaired gait function after burn injury. The participants were chronic patients who underwent split-thickness skin grafting or burns of more than 50%of the lower extremities and still had impaired gait dysfunction 6 months later. Eligible participants were aged over 18 years and had a Functional Ambulation Category (FAC) score of 3 or higher. This study excluded patients with fourth-degree burns (involving muscles, tendons, and bone injuries), severe communication disorders because of intellectual impairment and psychological problems. The specific exclusion criteria were as follows. Patients with body types that prevent them form wearing the robot, such as a height of 4.59 feet (140cm) or 5.91 feet (185cm) or more, or severe obesity with a BMI of 35 or more. Patients with heart and circulatory conditions that may affect gait training. Patients at a high risk of falling during gait training, owing to severe dizziness and having experienced a fall within the preceeding 2 month.Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. Assessments were carried out before and immediately after the 12-week training period. Physical ability were assessed using the functional ambulatory category(FAC) scale, the 6-Minute Walk Test (6MWT), and the visual analogue scale (VAS). Spatiotemporal gait parameters-including gait speed, cadence, and step length-and sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases were measured during gait analysis. Pulmonary function test such as forced vital capacity (FVC), 1-s forced expiratory volume (FEV1), and carbon monoxide (DLco). The highest maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) value were evaluated.
- Conditions
- Burns, Gait Dysfunction, Robot Training
- Being tested
- wearable robot training
- Keywords
- BURNS, Gait dysfunction, Wearable robot, Robot training
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable robot trainingOther
The wearable robot (WIRobotics Inc) is a wearable robot designed to provide assistive torque and resistive torque for hip movement. It is worn around the waist and thighs and weight approximately 1.6 kg. The main body and actuation parts are not located at the hip joints and back to avoid restricting body movements and to facilitate movement even in cramped spaces. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Wearable robot training | Experimental | The wearable robot (WIRobotics Inc) is a wearable robot designed to provide assistive torque and resistive torque for hip movement. It is worn around the waist and thighs and weight approximately 1.6 kg. The main body and actuation parts are not located at the hip joints and back to avoid restricting body movements and to facilitate movement even in cramped spaces. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. Receives: Other: wearable robot training |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional ambulatory category
Participants were rated on a six-point scale based on the level of physical assistance required for walking, regardless of whether an assistive device was used.
Measured: 12 weeks
Secondary outcomes (3)
6-Minute Walk Test (6MWT)
conducted according to standardized guidelines, on a 20-meter walking course. Patients were instructed to walk as far as possible in 6 min.
Measured: 12weeks
visual analogue scale (VAS)
rate the degree of subjective pain during gait movement (0 points : when no pain was noted, and 10 points : when unbearable pain was noted).
Measured: 12 weeks
sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases
the total range of motion of hip, knee, and ankle during one gait cycle
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start13 May 2025
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The wearable robot (WIRobotics Inc) is a wearable robot designed to provide assistive torque and resistive torque for hip movement. It is worn around the waist and thighs and weight approximately 1.6 kg. The main body and actuation parts are not located at the hip joints and back to avoid restricting body movements and to facilitate movement even in cramped spaces.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Young Joo, Hangang Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277166
- Sponsor's protocol ID
- HangangSHH-22
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
Shin JH, Byeon N, Yu H, Lee D, Lee HJ, Lee WH. Effect of wearable robot Bot Fit's hip joint-centered assist torque and voice coach on walking. BMC Musculoskelet Disord. 2024 Dec 23;25(1):1063. doi: 10.1186/s12891-024-08181-8.
PubMed 39716173Cho E, Hwang S, Heo SJ, Lim B, Lee J, Lee Y. Feasibility and Effects of a Gait Assistance and Gait Resistance Training Program Using a Walking-Assist Wearable Robot for Community-Dwelling Older Adults: Single-Group, Pre-, and Posttest Study. JMIR Mhealth Uhealth. 2025 May 26;13:e58142. doi: 10.2196/58142.
PubMed 40418849
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Robot Assisted Gait Training on Gait Performance in Chronic Patients With Impaired Gait Function After Burn Injury : Pilot Study
- ClinicalTrials.gov ID
- NCT07277166
- Acronym / sponsor ID
- HangangSHH-22
- Conditions
- Burns, Gait Dysfunction, Robot Training
- Keywords
- BURNS, Gait dysfunction, Wearable robot, Robot training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 11 Dec 2025 (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.
This study aims to examine the clinical effectiveness of gait training using wearable robots in patients with impaired gait function after burn injury. The participants were chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait dysfunction 6 months later. Eligible participants were aged over 18 years and had a Functional Ambulation Category (FAC) score of 3 or higher. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. Assessments were carried out before and immediately after the 12-week training period. Physical ability were assessed using the functional ambulatory category(FAC) scale, the 6-Minute Walk Test (6MWT), and the visual analogue scale (VAS). Spatiotemporal gait parameters-including gait speed, cadence, and step length-and sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases were measured during gait analysis. Pulmonary function test such as forced vital capacity (FVC), 1-s forced expiratory volume (FEV1), and carbon monoxide (DLco). The highest maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) value were evaluated.
Detailed description
Regaining a mobility level post-surgery that comes close to the patient's previous mobility as a baseline is the goal. It is commonly accepted that conventional physiotherapy after burn injury has a positive impact on muscle strength, range of motion, pain or gait performance which all impact patient mobility. Wearable robots that assist walking centered on the hip joint of the lower extremities are appearing. This wearable robot is a positive effect in terms of increased energy efficiency and posture during walking. This study aims to examine the clinical effectiveness of gait training using wearable robots in patients with impaired gait function after burn injury. The participants were chronic patients who underwent split-thickness skin grafting or burns of more than 50%of the lower extremities and still had impaired gait dysfunction 6 months later. Eligible participants were aged over 18 years and had a Functional Ambulation Category (FAC) score of 3 or higher. This study excluded patients with fourth-degree burns (involving muscles, tendons, and bone injuries), severe communication disorders because of intellectual impairment and psychological problems. The specific exclusion criteria were as follows. Patients with body types that prevent them form wearing the robot, such as a height of 4.59 feet (140cm) or 5.91 feet (185cm) or more, or severe obesity with a BMI of 35 or more. Patients with heart and circulatory conditions that may affect gait training. Patients at a high risk of falling during gait training, owing to severe dizziness and having experienced a fall within the preceeding 2 month.Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. Assessments were carried out before and immediately after the 12-week training period. Physical ability were assessed using the functional ambulatory category(FAC) scale, the 6-Minute Walk Test (6MWT), and the visual analogue scale (VAS). Spatiotemporal gait parameters-including gait speed, cadence, and step length-and sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases were measured during gait analysis. Pulmonary function test such as forced vital capacity (FVC), 1-s forced expiratory volume (FEV1), and carbon monoxide (DLco). The highest maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) value were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The wearable robot (WIRobotics Inc) is a wearable robot designed to provide assistive torque and resistive torque for hip movement. It is worn around the waist and thighs and weight approximately 1.6 kg. The main body and actuation parts are not located at the hip joints and back to avoid restricting body movements and to facilitate movement even in cramped spaces.
| Arm | Type | Receives |
|---|---|---|
| Wearable robot training | Experimental | Other: wearable robot trainingThe wearable robot (WIRobotics Inc) is a wearable robot designed to provide assistive torque and resistive torque for hip movement. It is worn around the waist and thighs and weight approximately 1.6 kg. The main body and actuation parts are not located at the hip joints and back to avoid restricting body movements and to facilitate movement even in cramped spaces. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait dysfunction 6 months later. -aged over 18 years
- had a Functional Ambulation Category (FAC) score of 3 or higher
Key exclusion criteria (5 listed)
- fourth-degree burns (involving muscles, tendons, and bone injuries)
- severe communication disorders because of intellectual impairment and psychological problems
- Patients with body types that prevent them form wearing the robot, such as a height of 4.59 feet (140cm) or 5.91 feet (185cm) or more, or severe obesity with a BMI of 35 or more.
- Patients with heart and circulatory conditions that may affect gait training.
- Patients at a high risk of falling during gait training, owing to severe dizziness and having experienced a fall within the preceeding 2 month.
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 |
|---|---|---|
| wearable robot trainingThe wearable robot (WIRobotics Inc) is a wearable robot designed to provide assistive torque and resistive torque for hip movement. It is worn around the waist and thighs and weight approximately 1.6 kg. The main body and actuation parts are not located at the hip joints and back to avoid restricting body movements and to facilitate movement even in cramped spaces. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. | Other | Wearable robot training |
Primary outcome
functional ambulatory category
Time frame: 12 weeks
Participants were rated on a six-point scale based on the level of physical assistance required for walking, regardless of whether an assistive device was used.
3 secondary outcomes
6-Minute Walk Test (6MWT)
Time frame: 12weeks
visual analogue scale (VAS)
Time frame: 12 weeks
sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Results publication: PubMed 39716173Shin JH, Byeon N, Yu H, Lee D, Lee HJ, Lee WH. Effect of wearable robot Bot Fit's hip joint-centered assist torque and voice coach on walking. BMC Musculoskelet Disord. 2024 Dec 23;25(1):1063. doi: 10.1186/s12891-024-08181-8.
- Results publication: PubMed 40418849Cho E, Hwang S, Heo SJ, Lim B, Lee J, Lee Y. Feasibility and Effects of a Gait Assistance and Gait Resistance Training Program Using a Walking-Assist Wearable Robot for Community-Dwelling Older Adults: Single-Group, Pre-, and Posttest Study. JMIR Mhealth Uhealth. 2025 May 26;13:e58142. doi: 10.2196/58142.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wearable robot training in people with Burns and Gait Dysfunction, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
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 2 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: looking for participants now, as of the sponsor's last update on 11 Dec 2025. 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 South Korea. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SO YOUNG JOO (82-10-3234-9839, anyany98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional ambulatory category (time frame: 12 weeks). 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 NCT07277166, which also lists 2 linked publications.
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 11 Dec 2025.