Clinical trial NCT04281394: Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity
Official title: Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Gait Disorder, Sensorimotor
Keywords: burns
rehabilitation
robot assisted gait training
Lead sponsor: Hangang Sacred Heart Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Republic of Korea
First posted: 2020-02-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients with full or virtually full thickness involvement of \>50% on the body surface area of the lower extremity
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the changes of functional ambulatory category
timeFrame: baseline, and after 12 weeks intervention
measure: the changes of 6 minutes walking test
timeFrame: baseline, and after 12 weeks intervention
measure: the changes of visual analogue scale
timeFrame: baseline, and after 12 weeks intervention
Secondary outcomes:
measure: the changes of active range of motion of flexion and extension
timeFrame: baseline, and after 12 weeks intervention
measure: the changes of active range of motion of flexion and extension
timeFrame: baseline, and after 12 weeks intervention
measure: the changes of active range of motion of dorsiflexion and plantarflexion
timeFrame: baseline, and after 12 weeks intervention
measure: the changes of isometric forces of knee flexion and knee extension
timeFrame: baseline, and after 12 weeks intervention
measure: the changes of isometric forces of ankle dorsiflexion and ankle plantarflexion
timeFrame: baseline, and after 12 weeks intervention
measure: the changes of gait symmetry using stride length
timeFrame: baseline, and after 12 weeks intervention
measure: the changes of center of foot pressure pattern
timeFrame: baseline, and after 12 weeks intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hangang Sacred Heart Hospital
state: Yeong-deungpo-Dong
Study officials:
References:
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citation: 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.