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Enrolling by invitationNCT07578753Updated May 11, 2026

Clinical Effectiveness of Robot-assisted Gait Training in Patients With Lower Limb Burns Accompanied by Fractures: Pilot Study

An interventional study of robot assisted gait training in Burn, Fracture and Robot Assisted Gait Training, sponsored by Hangang Sacred Heart Hospital. Enrolling by invitation at 1 site in South Korea. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Hangang Sacred Heart Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Apr 2024, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Burn
  • Fracture
  • Robot Assisted Gait Training

Keywords

  • Burn
  • Fracture
  • Robot assisted gait training
03

In context

Burns

905 studies on the registry are indexed under Burns; 164 are open to participants now.

This study's planned enrollment of 5 is below the median of 40 across 663 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

Hangang Sacred Heart Hospital is the lead sponsor of 25 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Other
    robot assited 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.

    Other: robot assisted gait training

Interventions

  • Otherrobot assisted 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. manual muscle test, MMT

    . Lower limb muscle strength was assessed using the MMT based on the Medical Research Council scale for muscle strength.

    Time frame: 8 weeks

  2. active range of motion (AROM) of the lower limbs

    Full AROM of the hip, knee, and ankle joints was measured before and after training.

    Time frame: 8 weeks

  3. 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).

    Time frame: 8 weeks

  4. 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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Hangang Sacred Heart Hospital
    Seoul, 07247, South Korea
08

References and documents

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 38486633 ↗
  • Iziumov 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 ↗

Individual participant data

Plan to share: Yes — We plan to disclose it upon a legitimate request from the corresponding author.

Supporting information: Study protocol

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Dec 2026, 32 months after the start.

Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 32 months is above that.

Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2026
First posted
May 11, 2026
StartActual
Apr 15, 2024
Primary completionEst.
Dec 25, 2026
CompletionEst.
Dec 30, 2026
Last update
May 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07578753
Lead sponsor
Hangang Sacred Heart Hospital
Responsible party
Sponsor
First posted
May 11, 2026
Start date
Apr 15, 2024
Primary completion
Dec 25, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
May 11, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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