BurnNCT07578753
Clinical Effectiveness of Robot-assisted Gait Training in Patients With Lower Limb Burns Accompanied by Fractures: Pilot Study
A study testing robot assisted gait training in people with Burn and Fracture, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Gait dysfunction, common in patients with lower limb burns accompanied by fractures, requires acute rehabilitation. This study investigated the clinical effects of robot-assisted gait training (RAGT) on gait function in patients with lower limb burns accompanied by fractures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Burn, Fracture, Robot Assisted Gait Training
- What is being tested?
- robot assisted gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Apr 2024to 30 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 19 years or older
- admitted to the Department of Rehabilitation Medicine after the wound had epithelialized following wound treatment via skin grafting or aseptic dressing procedures
- underwent fixation or brace treatment after a lower limb fracture was diagnosed via imaging at the time of injury
- sufficient cognitive function to follow the therapist's instructions during training
- a functional ambulatory category (FAC) of 1 or higher and 3 or lower.
Who cannot join
- unable to bear weight owing to fracture union failure or complications such as osteomyelitis
- severe pain rendering the patient unable to wear the robotic device
- scars that may bleed or become infected when wearing the robotic device
- a history of lower limb weakness or reduced gait ability due to other causes prior to injury
- lower limb sensory disturbances caused by peripheral neuropathic diseases such as diabetes
- height less than 120 cm or body mass more than 120 kg
- withdrawal of consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Gait dysfunction, common in patients with lower limb burns accompanied by fractures, requires acute rehabilitation. This study investigated the clinical effects of robot-assisted gait training (RAGT) on gait function in patients with lower limb burns accompanied by fractures.
In this preliminary study, RAGT will be conducted using an end-effector-type gait-training robot. Participants will receive 60 min of gait training daily (30 min of conventional gait training and 30 min of RAGT) for 8 weeks. We plan to conduct clinical evaluations related to gait function of the participants included in the preliminary study before training and after 8 weeks of training.
Read the detailed description
Background : Gait dysfunction, common in patients with lower limb burns accompanied by fractures, requires acute rehabilitation. This study investigated the clinical effects of robot-assisted gait training (RAGT) on gait function in patients with lower limb burns accompanied by fractures.
Material and Methods: In this preliminary study, RAGT will be conducted using an end-effector-type gait-training robot. Participants will receive 60 min of gait training daily (30 min of conventional gait training and 30 min of RAGT) for 8 weeks. We plan to conduct clinical evaluations related to gait function of the participants included in the preliminary study before training and after 8 weeks of training. To evaluate clinical efficacy, functional ambulation category (FAC), muscle strength (manual muscle test, MMT), active range of motion (AROM) of the lower limbs, 6-minute walking test (6 MWT), pain score, gait kinematics, and spatiotemporal gait parameters will be measured before and after 8 weeks training.
- Conditions
- Burn, Fracture, Robot Assisted Gait Training
- Being tested
- robot assisted gait training
- Keywords
- Burn, Fracture, Robot assisted gait training
- Medical subject headings
- Burns, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot assisted gait trainingOther
All participants underwent 60 min of daily gait training consisting of 30 min of conventional physical therapy in the morning and 30 min of RAGT in the afternoon. All participants underwent 40 gait training sessions over 8 weeks, five times per week. Conventional physical training consisted of ROM exercises and strength training for the lower limbs and ground gait training once weight bearing was possible.
| Study group | Role | What they receive |
|---|---|---|
| robot assited gait training | Other | All participants underwent 60 min of daily gait training consisting of 30 min of conventional physical therapy in the morning and 30 min of RAGT in the afternoon. All participants underwent 40 gait training sessions over 8 weeks, five times per week. Conventional physical training consisted of ROM exercises and strength training for the lower limbs and ground gait training once weight bearing was possible. Receives: Other: robot assisted gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional ambulatory category
Ambulatory ability was assessed using the FAC scale. 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: 8 weeks
Secondary outcomes (4)
manual muscle test, MMT
. Lower limb muscle strength was assessed using the MMT based on the Medical Research Council scale for muscle strength.
Measured: 8 weeks
active range of motion (AROM) of the lower limbs
Full AROM of the hip, knee, and ankle joints was measured before and after training.
Measured: 8 weeks
pain score (visual analog scale, VAS)
A visual analog scale (VAS) was used to rate the degree of subjective pain during gait movement (0 points: no pain, 10 points: unbearable pain).
Measured: 8 weeks
6-minute walking test (6 MWT)
The 6 MWT was conducted according to standardized guidelines on a 20-m walking course. Patients were instructed to walk as far as possible within 6 min.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start15 Apr 2024
- Primary completion25 Dec 2026 (estimated)
- Study completion30 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 BurnStudies 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
- RAGT and conventional gait training were performed by a physical therapist with more than 7 years of experience with patients with burns. Complications in the scar area and worsening of pain were monitored during gait training. All participants underwent 60 min of daily gait training consisting of 30 min of conventional physical therapy in the morning and 30 min of RAGT in the afternoon. All participants underwent 40 gait training sessions over 8 weeks, five times per week. Conventional physical training consisted of ROM exercises and strength training for the lower limbs and ground gait training once weight bearing was possible.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578753
- Sponsor's protocol ID
- HangangSHH-23
- Status last verified
- Apr 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to disclose it upon a legitimate request from the corresponding author.
Publications
Franks PW, Bryan GM, Martin RM, Reyes R, Lakmazaheri AC, Collins SH. Comparing optimized exoskeleton assistance of the hip, knee, and ankle in single and multi-joint configurations. Wearable Technol. 2021 Nov 24;2:e16. doi: 10.1017/wtc.2021.14. eCollection 2021.
PubMed 38486633Iziumov A, Hussein TS, Kosenko E, Nazarov A. Adaptive Exoskeleton Device for Stress Reduction in the Ankle Joint Orthosis. Sensors (Basel). 2025 Jan 30;25(3):832. doi: 10.3390/s25030832.
PubMed 39943472
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Robot-assisted Gait Training in Patients With Lower Limb Burns Accompanied by Fractures: Pilot Study
- ClinicalTrials.gov ID
- NCT07578753
- Acronym / sponsor ID
- HangangSHH-23
- Conditions
- Burn, Fracture, Robot Assisted Gait Training
- Keywords
- Burn, Fracture, Robot assisted gait training
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 May 2026 (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.
Gait dysfunction, common in patients with lower limb burns accompanied by fractures, requires acute rehabilitation. This study investigated the clinical effects of robot-assisted gait training (RAGT) on gait function in patients with lower limb burns accompanied by fractures.
In this preliminary study, RAGT will be conducted using an end-effector-type gait-training robot. Participants will receive 60 min of gait training daily (30 min of conventional gait training and 30 min of RAGT) for 8 weeks. We plan to conduct clinical evaluations related to gait function of the participants included in the preliminary study before training and after 8 weeks of training.
Detailed description
Background : Gait dysfunction, common in patients with lower limb burns accompanied by fractures, requires acute rehabilitation. This study investigated the clinical effects of robot-assisted gait training (RAGT) on gait function in patients with lower limb burns accompanied by fractures.
Material and Methods: In this preliminary study, RAGT will be conducted using an end-effector-type gait-training robot. Participants will receive 60 min of gait training daily (30 min of conventional gait training and 30 min of RAGT) for 8 weeks. We plan to conduct clinical evaluations related to gait function of the participants included in the preliminary study before training and after 8 weeks of training. To evaluate clinical efficacy, functional ambulation category (FAC), muscle strength (manual muscle test, MMT), active range of motion (AROM) of the lower limbs, 6-minute walking test (6 MWT), pain score, gait kinematics, and spatiotemporal gait parameters will be measured before and after 8 weeks training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- RAGT and conventional gait training were performed by a physical therapist with more than 7 years of experience with patients with burns. Complications in the scar area and worsening of pain were monitored during gait training. All participants underwent 60 min of daily gait training consisting of 30 min of conventional physical therapy in the morning and 30 min of RAGT in the afternoon. All participants underwent 40 gait training sessions over 8 weeks, five times per week. Conventional physical training consisted of ROM exercises and strength training for the lower limbs and ground gait training once weight bearing was possible.
| Arm | Type | Receives |
|---|---|---|
| robot assited gait training | Other | Other: robot assisted gait trainingAll participants underwent 60 min of daily gait training consisting of 30 min of conventional physical therapy in the morning and 30 min of RAGT in the afternoon. All participants underwent 40 gait training sessions over 8 weeks, five times per week. Conventional physical training consisted of ROM exercises and strength training for the lower limbs and ground gait training once weight bearing was possible. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 19 years or older
- admitted to the Department of Rehabilitation Medicine after the wound had epithelialized following wound treatment via skin grafting or aseptic dressing procedures
- underwent fixation or brace treatment after a lower limb fracture was diagnosed via imaging at the time of injury
- sufficient cognitive function to follow the therapist's instructions during training
- a functional ambulatory category (FAC) of 1 or higher and 3 or lower.
Key exclusion criteria (7 listed)
- unable to bear weight owing to fracture union failure or complications such as osteomyelitis
- severe pain rendering the patient unable to wear the robotic device
- scars that may bleed or become infected when wearing the robotic device
- a history of lower limb weakness or reduced gait ability due to other causes prior to injury
- lower limb sensory disturbances caused by peripheral neuropathic diseases such as diabetes
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 |
|---|---|---|
| robot assisted gait trainingAll participants underwent 60 min of daily gait training consisting of 30 min of conventional physical therapy in the morning and 30 min of RAGT in the afternoon. All participants underwent 40 gait training sessions over 8 weeks, five times per week. Conventional physical training consisted of ROM exercises and strength training for the lower limbs and ground gait training once weight bearing was possible. | Other | robot assited gait training |
Primary outcome
functional ambulatory category
Time frame: 8 weeks
Ambulatory ability was assessed using the FAC scale. 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.
4 secondary outcomes
manual muscle test, MMT
Time frame: 8 weeks
active range of motion (AROM) of the lower limbs
Time frame: 8 weeks
pain score (visual analog scale, VAS)
Time frame: 8 weeks
6-minute walking test (6 MWT)
Time frame: 8 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 May 2026.
- Results publication: PubMed 38486633Franks PW, Bryan GM, Martin RM, Reyes R, Lakmazaheri AC, Collins SH. Comparing optimized exoskeleton assistance of the hip, knee, and ankle in single and multi-joint configurations. Wearable Technol. 2021 Nov 24;2:e16. doi: 10.1017/wtc.2021.14. eCollection 2021.
- Results publication: PubMed 39943472Iziumov A, Hussein TS, Kosenko E, Nazarov A. Adaptive Exoskeleton Device for Stress Reduction in the Ankle Joint Orthosis. Sensors (Basel). 2025 Jan 30;25(3):832. doi: 10.3390/s25030832.
- Individual participant dataSharing planned: Yes. We plan to disclose it upon a legitimate request from the corresponding author.
Related trials for Burn
Recruiting
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Burns
Not yet recruitingObservational study
Recurrence of Extremity Joint Contracture After Z-Plasty Versus Full-Thickness Skin Graft
Joint Contracture, Contracture
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Impact of Range of Motion Exercises on Pain and Functional Ability
Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree Burns
Enrolling by invitationObservational study
Evaluating the Accuracy of Multiple Blood Tests to Diagnose Sepsis in Adult Burn Patients
Sepsis - to Reduce Mortality in the Intensive Care Unit, Burns Involving 20% or More of Body Surface
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.
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 robot assisted gait training in people with Burn and Fracture, 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 5 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 11 May 2026. 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?
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?
functional ambulatory category (time frame: 8 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 NCT07578753, 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 May 2026.