BurnsNCT06564090
Effect on Gait Pattern During Robot Assisted Gait Training (RAGT) of End-effector Type in Burn Patients
A study testing robot assisted gait training and conventional gait training in people with Burns and Gait Training, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
Trial summary
This study aimed to investigate gait pattern and muscles power improvement of patient with gait disturbance caused by burns after end-effector type robot (Morning Walk®)-assited gait training (RAGT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Burns, Gait Training, Rehabilitation
- What is being tested?
- robot assisted gait training and conventional gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Aug 2023to 30 Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent split thickness skin graft (STSG) at Hangang Sacred Heart Hospital
- with full or virtually full thickness involvement ( >50% of the body surface area of the lower extremity)
- aged >18 years
- with ≤ 1 functional ambulation category (FAC) score of ≤3 were included in this study.
Who cannot join
- who had fourth-degree burns (involving muscles, tendons, and bone injuries)
- severe communication disorders due to intellectual impairment and psychologic problems
- body weight > 135kg or height >195cm
- physical status that could limit physical therapy (severe deformity or contracture of limbs, open wounds, or pressure ulcers, severe osteoporosis).
Trial locations and contacts
1 site in 1 country.
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
This study aimed to investigate gait pattern and muscles power improvement of patient with gait disturbance caused by burns after end-effector type robot (Morning Walk®)-assited gait training (RAGT). This study randomly assigned 36 patients to one of two group : 30 minutes of Morning Walk® training with 30 minutes conventional physiotherapy (RAGT group) or 60 minutes of conventional physiotherapy (CON group). Five training sessions per week were given for 8 weeks. The primary outcomes were gait performance and muscles powers, which were assessed by the functional ambulation category (FAC) and the manual muscles test (MMT), respectively. The secondary outcomes included 6-minute walking test (6MWT), gait kinematic and spatiotemporal gait parameters. The results of this study is anticipated that the patients with gait disturbance receiving the RAGT might improve greater in gait performance and normal gait patterns that those trained with conventional physiotherapy.
Read the detailed description
Patients with burn injuries to the lower extremities experience gait dysfunctions due to pain or joint contractures, and gait asymmetry occurs due to complications on the affected side. The persisting gait asymmetry placed these patients at risk for potential negative consequences, such as loss of bone mineral density of the affected side, overuse injury on the unaffected side due to compensatory actions, compromised postural control, and gait inefficiencies. Early gait training through physical therapy is a pivotal strategy for enhancing patients' quality of life, functional outcomes and mitigating burn-related complications. The conventional physical therapy is instrumental in fostering an increased range of motion (ROM) and mitigating contractures following burns or skin grafts. Physical therapy centers on patients' positioning, ROM, muscles strength, endurance, balance, coordination, and respiratory rehabilitation.Previous studies using end-effector type RAGT for patients with gait disturbances have demonstrated that RAGT combined with conventional physiotherapy could significantly improved walking speed, gait performance, and motor power . This study aimed to investigate gait pattern and muscles power improvement of patient with gait disturbance caused by burns after end-effector type robot (Morning Walk®)-assited gait training (RAGT).
This study randomly assigned 36 patients to one of two group : 30 minutes of Morning Walk® training with 30 minutes conventional physiotherapy (RAGT group) or 60 minutes of conventional physiotherapy (CON group). Five training sessions per week were given for 8 weeks. The primary outcomes were gait performance and muscles powers, which were assessed by the functional ambulation category (FAC) and the manual muscles test (MMT), respectively. The secondary outcomes included 6-minute walking test (6MWT), gait kinematic and spatiotemporal gait parameters. The results of this study is anticipated that the patients with gait disturbance receiving the RAGT might improve greater in gait performance and normal gait patterns that those trained with conventional physiotherapy.
- Conditions
- Burns, Gait Training, Rehabilitation
- Being tested
- robot assisted gait training, conventional gait training
- Keywords
- burns, gait pattern, robot assisted gait training
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot assisted gait trainingOther
Morning Walk® is a new end-effector type robot developed by Hyundai Heavy Industries and Taeha Mechatronics for lower limb rehabilitation in the patients with gait disturbance.The RAGT group received RAGT with robot training for 30 minutes and conventional physiotherapy for 30 minutes per session.
conventional gait trainingOther
The control group received conventional physiotherapy for 60 minutes per session. Conventional physiotherapy consisted of 30 minutes of therapist-assisted gait and balance training and 30 minutes of strengthening exercises. The both group patients received five training sessions per week for 8 weeks (a total of 40 sessions).
| Study group | Role | What they receive |
|---|---|---|
| robot assisted gait training | Experimental | Morning Walk® is a new end-effector type robot developed by Hyundai Heavy Industries and Taeha Mechatronics for lower limb rehabilitation in the patients with gait disturbance.The RAGT group received RAGT with robot training for 30 minutes and conventional physiotherapy for 30 minutes per session Receives: Other: robot assisted gait training; Other: conventional gait training |
| conventioanl gait training | Active comparator | The control group received conventional physiotherapy for 60 minutes per session. Conventional physiotherapy consisted of 30 minutes of therapist-assisted gait and balance training and 30 minutes of strengthening exercises. The both group patients received five training sessions per week for 8 weeks (a total of 40 sessions). Receives: Other: conventional 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 rated by using the functional ambulatory category (FAC) scale.
Measured: 8 weeks
Secondary outcomes (4)
6 minute walking test
6MWT was performed in accordance with the standardised guidelines, and the walking course was 20 m. Patients were instructed to walk as far as possible in 6 min
Measured: 8 weeks
gait parameters(cadence)
steps/minutes
Measured: 8 weeks
gait parameters(gait speed)
Measure walking speed
Measured: 8 weeks
gait parameters(step length)
Measure the distance between steps
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 posted21 Aug 2024
- Study start15 Aug 2023
- Primary completion15 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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
- NCT06564090
- Sponsor's protocol ID
- HangangSHH-20
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ebid AA, Attalla AF, Ibrahim AR, Mohamdy HM. Effect of anti-gravity treadmill (Alter G) training on gait characteristics and postural stability in adult with healed burns: A single blinded randomized controlled trial. Burns. 2024 Feb;50(1):106-114. doi: 10.1016/j.burns.2023.09.004. Epub 2023 Sep 20.
PubMed 37798213
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Gait Pattern During Robot Assisted Gait Training (RAGT) of End-effector Type in Burn Patients
- ClinicalTrials.gov ID
- NCT06564090
- Acronym / sponsor ID
- HangangSHH-20
- Conditions
- Burns, Gait Training, Rehabilitation
- Keywords
- burns, gait pattern, robot assisted gait training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Aug 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.
This study aimed to investigate gait pattern and muscles power improvement of patient with gait disturbance caused by burns after end-effector type robot (Morning Walk®)-assited gait training (RAGT). This study randomly assigned 36 patients to one of two group : 30 minutes of Morning Walk® training with 30 minutes conventional physiotherapy (RAGT group) or 60 minutes of conventional physiotherapy (CON group). Five training sessions per week were given for 8 weeks. The primary outcomes were gait performance and muscles powers, which were assessed by the functional ambulation category (FAC) and the manual muscles test (MMT), respectively. The secondary outcomes included 6-minute walking test (6MWT), gait kinematic and spatiotemporal gait parameters. The results of this study is anticipated that the patients with gait disturbance receiving the RAGT might improve greater in gait performance and normal gait patterns that those trained with conventional physiotherapy.
Detailed description
Patients with burn injuries to the lower extremities experience gait dysfunctions due to pain or joint contractures, and gait asymmetry occurs due to complications on the affected side. The persisting gait asymmetry placed these patients at risk for potential negative consequences, such as loss of bone mineral density of the affected side, overuse injury on the unaffected side due to compensatory actions, compromised postural control, and gait inefficiencies. Early gait training through physical therapy is a pivotal strategy for enhancing patients' quality of life, functional outcomes and mitigating burn-related complications. The conventional physical therapy is instrumental in fostering an increased range of motion (ROM) and mitigating contractures following burns or skin grafts. Physical therapy centers on patients' positioning, ROM, muscles strength, endurance, balance, coordination, and respiratory rehabilitation.Previous studies using end-effector type RAGT for patients with gait disturbances have demonstrated that RAGT combined with conventional physiotherapy could significantly improved walking speed, gait performance, and motor power . This study aimed to investigate gait pattern and muscles power improvement of patient with gait disturbance caused by burns after end-effector type robot (Morning Walk®)-assited gait training (RAGT).
This study randomly assigned 36 patients to one of two group : 30 minutes of Morning Walk® training with 30 minutes conventional physiotherapy (RAGT group) or 60 minutes of conventional physiotherapy (CON group). Five training sessions per week were given for 8 weeks. The primary outcomes were gait performance and muscles powers, which were assessed by the functional ambulation category (FAC) and the manual muscles test (MMT), respectively. The secondary outcomes included 6-minute walking test (6MWT), gait kinematic and spatiotemporal gait parameters. The results of this study is anticipated that the patients with gait disturbance receiving the RAGT might improve greater in gait performance and normal gait patterns that those trained with conventional physiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robot assisted gait training | Experimental | Other: robot assisted gait training, Other: conventional gait trainingMorning Walk® is a new end-effector type robot developed by Hyundai Heavy Industries and Taeha Mechatronics for lower limb rehabilitation in the patients with gait disturbance.The RAGT group received RAGT with robot training for 30 minutes and conventional physiotherapy for 30 minutes per session |
| conventioanl gait training | Active comparator | Other: conventional gait trainingThe control group received conventional physiotherapy for 60 minutes per session. Conventional physiotherapy consisted of 30 minutes of therapist-assisted gait and balance training and 30 minutes of strengthening exercises. The both group patients received five training sessions per week for 8 weeks (a total of 40 sessions). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who underwent split thickness skin graft (STSG) at Hangang Sacred Heart Hospital
- with full or virtually full thickness involvement ( >50% of the body surface area of the lower extremity)
- aged >18 years
- with ≤ 1 functional ambulation category (FAC) score of ≤3 were included in this study.
Key exclusion criteria (4 listed)
- who had fourth-degree burns (involving muscles, tendons, and bone injuries)
- severe communication disorders due to intellectual impairment and psychologic problems
- body weight > 135kg or height >195cm
- physical status that could limit physical therapy (severe deformity or contracture of limbs, open wounds, or pressure ulcers, severe osteoporosis).
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 trainingMorning Walk® is a new end-effector type robot developed by Hyundai Heavy Industries and Taeha Mechatronics for lower limb rehabilitation in the patients with gait disturbance.The RAGT group received RAGT with robot training for 30 minutes and conventional physiotherapy for 30 minutes per session. | Other | robot assisted gait training |
| conventional gait trainingThe control group received conventional physiotherapy for 60 minutes per session. Conventional physiotherapy consisted of 30 minutes of therapist-assisted gait and balance training and 30 minutes of strengthening exercises. The both group patients received five training sessions per week for 8 weeks (a total of 40 sessions). | Other | conventioanl gait training, robot assisted gait training |
Primary outcome
functional ambulatory category
Time frame: 8 weeks
Ambulatory ability was rated by using the functional ambulatory category (FAC) scale.
4 secondary outcomes
6 minute walking test
Time frame: 8 weeks
gait parameters(cadence)
Time frame: 8 weeks
gait parameters(gait speed)
Time frame: 8 weeks
gait parameters(step length)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Results publication: PubMed 37798213Ebid AA, Attalla AF, Ibrahim AR, Mohamdy HM. Effect of anti-gravity treadmill (Alter G) training on gait characteristics and postural stability in adult with healed burns: A single blinded randomized controlled trial. Burns. 2024 Feb;50(1):106-114. doi: 10.1016/j.burns.2023.09.004. Epub 2023 Sep 20.
- 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.
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 and conventional gait training in people with Burns and Gait Training, 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Aug 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Rakyum (82-2-2639-5900, sung6652@hallym.or.kr), 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: 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 NCT06564090, 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 21 Aug 2024.