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BurnsNCT04281394

Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity

A study testing Robot assisted gait training and conventional gait training in people with Burns and Gait Disorder, Sensorimotor, run by Hangang Sacred Heart Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Gait enables individuals to move forward and is considered a natural skill. However, gait disturbances are very common in patients with burn injury. Major causes of functional impairment are pain and joint contractures. Recent studies focused on the application of robot-assisted gait training (RAGT). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Burns, Gait Disorder, Sensorimotor
What is being tested?
Robot assisted gait training and conventional gait training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSouth Korea
Study dates
25 Oct 2019to 24 Feb 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with full or virtually full thickness involvement of >50% on the body surface area of the lower extremity
  • age > 18 years
  • with ≤1 functional ambulation category (FAC) score ≤ 3

Who cannot join

  • patients with cognitive disorders before burn
  • serious cardiac dysfunction
  • problems with weight bearing due to unstable fractures
  • body weight ≥100 kg
  • severe fixed contracture
  • skin disorders that could be worsened by RAGT and conventional rehabilitation
  • patients with severe pain who were unable to undergo conventional rehabilitation programs.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Hangang Sacred Heart Hospital

    Seoul, Yeong-deungpo-Dong, 150-719

Other trials in South Korea

About this study

Official title: Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity : a Randomized Controlled Trial

Gait enables individuals to move forward and is considered a natural skill. However, gait disturbances are very common in patients with burn injury. Major causes of functional impairment are pain and joint contractures. Recent studies focused on the application of robot-assisted gait training (RAGT). This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn.

Read the detailed description

This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn.

20 patients with burn were randomly divided into 2 groups. RAGT group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks. SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. The conventional group underwent conventional physical therapy twice a day, 5 times a week in 12 weeks. Main outcomes were functional ambulatory category(FAC), 6 minutes walking test(6MWT), visual analogue scale(VAS), isometric forces of bilateral knee and ankle muscles, and foot pressure analysis before and after 12 weeks training.

Being tested
Robot assisted gait training, conventional gait training
Keywords
burns, rehabilitation, robot assisted gait training
Medical subject headings
Burns, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot assisted gait trainingDevice

    SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. RAGT group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks.

  • conventional gait trainingOther

    even level gait training and range of motion exercises

Study groups in NCT04281394
Study groupRoleWhat they receive
Robot assisted gait trainingExperimentalRobot assisted gait training(RAGT) group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks. SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements.
Receives: Device: Robot assisted gait training
conventional physical training groupActive comparatorThe conventional group underwent conventional physical therapy( even level gait training and range of motion exercises) twice a day, 5 times a week in 12 weeks.
Receives: Other: conventional gait training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the changes of functional ambulatory category

    Scale 0 means that the patient cannot walk or can only walk with assistance of two people. Scale 5 means that the patient can walk independently. Higher scores mean a better outcome.

    Measured: baseline, and after 12 weeks intervention

  2. the changes of 6 minutes walking test

    6MWT was performed in accordance with standardized guidelines, and the walking course was 20 m. Patients were instructed to walk as far as possible in 6 min. Higher scores mean a better outcome.

    Measured: baseline, and after 12 weeks intervention

  3. the changes of visual analogue scale

    Visual analogue scale was used to rate the degree of subjective pain during gait movement: 0 points were assigned when no pain was noted, and unbearable pain was assigned 10 points. higher scores mean a worse outcome

    Measured: baseline, and after 12 weeks intervention

Secondary outcomes (7)

  1. the changes of active range of motion of flexion and extension

    The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(hip joint)

    Measured: baseline, and after 12 weeks intervention

  2. the changes of active range of motion of flexion and extension

    The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(knee joint)

    Measured: baseline, and after 12 weeks intervention

  3. the changes of active range of motion of dorsiflexion and plantarflexion

    The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(ankle joint)

    Measured: baseline, and after 12 weeks intervention

  4. the changes of isometric forces of knee flexion and knee extension

    Isometric knee extension and knee flexion muscle strength were measured by handheld dynamometer. Two measurements were taken using handheld dynamometer. Each trial lasted for 3-5 s, with 30 second rest period between trials. The higher of the two valid measurements was recorded.

    Measured: baseline, and after 12 weeks intervention

  5. the changes of isometric forces of ankle dorsiflexion and ankle plantarflexion

    Isometric ankle dorsiflexion, and ankle plantar flexion muscle strength were measured by handheld dynamometer. Two measurements were taken using handheld dynamometer. Each trial lasted for 3-5 s, with 30 second rest period between trials. The higher of the two valid measurements was recorded.

    Measured: baseline, and after 12 weeks intervention

  6. the changes of gait symmetry using stride length

    Stride is the equivalent of a gait cycle. The duration of a stride is the interval between two sequential initial floor contacts by the same limb. symmetry ratio is defined with affected side stride length/ non affected side stride length.

    Measured: baseline, and after 12 weeks intervention

  7. the changes of center of foot pressure pattern

    center of foot pressure patten during a normal stride. longitudinal line analysis

    Measured: baseline, and after 12 weeks intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2020
  2. Study start25 Oct 2019
  3. Primary completion24 Feb 2020
  4. Study completion24 Feb 2020

Resources

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
Parallel groups
Model description
patients with full or virtually full thickness involvement of \>50% on the body surface area of the lower extremity
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04281394
Sponsor's protocol ID
HangangSHH-8
Status last verified
Oct 2019
First submitted
22 Oct 2019
Last updated
26 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Goto K, Morishita T, Kamada S, Saita K, Fukuda H, Shiota E, Sankai Y, Inoue T. Feasibility of rehabilitation using the single-joint hybrid assistive limb to facilitate early recovery following total knee arthroplasty: A pilot study. Assist Technol. 2017 Winter;29(4):197-201. doi: 10.1080/10400435.2016.1219883. Epub 2016 Aug 10.

    PubMed 27689789

  • Kang MG, Yun SJ, Shin HI, Kim E, Lee HH, Oh BM, Seo HG. Effects of robot-assisted gait training in patients with Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2019 Jan 7;20(1):15. doi: 10.1186/s13063-018-3123-4.

    PubMed 30616685

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 Disorder, Sensorimotor, 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 3 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: finished, as of the sponsor's last update on 26 Feb 2020. 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?

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?

the changes of functional ambulatory category (time frame: baseline, and after 12 weeks intervention). The study lists 3 primary outcomes in all. 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 NCT04281394, 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 26 Feb 2020.

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