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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04281394
Enrollment
28
Registered
2020-02-24
Start date
2019-10-25
Completion date
2020-02-24
Last updated
2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Gait Disorder, Sensorimotor

Keywords

burns, rehabilitation, robot assisted gait training

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

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.

Interventions

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.

even level gait training and range of motion exercises

Sponsors

Ministry of Health, Republic of Korea
CollaboratorOTHER_GOV
Hangang Sacred Heart Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

patients with full or virtually full thickness involvement of \>50% on the body surface area of the lower extremity

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
the changes of functional ambulatory categorybaseline, and after 12 weeks interventionScale 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.
the changes of 6 minutes walking testbaseline, and after 12 weeks intervention6MWT 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.
the changes of visual analogue scalebaseline, and after 12 weeks interventionVisual 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

Secondary

MeasureTime frameDescription
the changes of isometric forces of ankle dorsiflexion and ankle plantarflexionbaseline, and after 12 weeks interventionIsometric 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.
the changes of active range of motion of flexion and extensionbaseline, and after 12 weeks interventionThe active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(hip joint)
the changes of center of foot pressure patternbaseline, and after 12 weeks interventioncenter of foot pressure patten during a normal stride. longitudinal line analysis
the changes of gait symmetry using stride lengthbaseline, and after 12 weeks interventionStride 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.
the changes of active range of motion of dorsiflexion and plantarflexionbaseline, and after 12 weeks interventionThe active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(ankle joint)
the changes of isometric forces of knee flexion and knee extensionbaseline, and after 12 weeks interventionIsometric 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026