Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity
Primary Purpose
Burns, Gait Disorder, Sensorimotor
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Robot assisted gait training
conventional gait training
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring burns, rehabilitation, robot assisted gait 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.
Sites / Locations
- Hangang Sacred Heart Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robot assisted gait training
conventional physical training group
Arm Description
Robot 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.
The 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.
Outcomes
Primary Outcome Measures
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.
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.
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
Secondary Outcome Measures
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)
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)
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)
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.
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.
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.
the changes of center of foot pressure pattern
center of foot pressure patten during a normal stride. longitudinal line analysis
Full Information
NCT ID
NCT04281394
First Posted
October 22, 2019
Last Updated
February 24, 2020
Sponsor
Hangang Sacred Heart Hospital
Collaborators
Ministry of Health, Republic of Korea
1. Study Identification
Unique Protocol Identification Number
NCT04281394
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
February 24, 2020 (Actual)
Study Completion Date
February 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangang Sacred Heart Hospital
Collaborators
Ministry of Health, Republic of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Gait Disorder, Sensorimotor
Keywords
burns, rehabilitation, robot assisted gait training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robot assisted gait training
Arm Type
Experimental
Arm Description
Robot 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.
Arm Title
conventional physical training group
Arm Type
Active Comparator
Arm Description
The 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.
Intervention Type
Device
Intervention Name(s)
Robot assisted gait training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional gait training
Intervention Description
even level gait training and range of motion exercises
Primary Outcome Measure Information:
Title
the changes of functional ambulatory category
Description
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.
Time Frame
baseline, and after 12 weeks intervention
Title
the changes of 6 minutes walking test
Description
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.
Time Frame
baseline, and after 12 weeks intervention
Title
the changes of visual analogue scale
Description
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
Time Frame
baseline, and after 12 weeks intervention
Secondary Outcome Measure Information:
Title
the changes of active range of motion of flexion and extension
Description
The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(hip joint)
Time Frame
baseline, and after 12 weeks intervention
Title
the changes of active range of motion of flexion and extension
Description
The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(knee joint)
Time Frame
baseline, and after 12 weeks intervention
Title
the changes of active range of motion of dorsiflexion and plantarflexion
Description
The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(ankle joint)
Time Frame
baseline, and after 12 weeks intervention
Title
the changes of isometric forces of knee flexion and knee extension
Description
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.
Time Frame
baseline, and after 12 weeks intervention
Title
the changes of isometric forces of ankle dorsiflexion and ankle plantarflexion
Description
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.
Time Frame
baseline, and after 12 weeks intervention
Title
the changes of gait symmetry using stride length
Description
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.
Time Frame
baseline, and after 12 weeks intervention
Title
the changes of center of foot pressure pattern
Description
center of foot pressure patten during a normal stride. longitudinal line analysis
Time Frame
baseline, and after 12 weeks intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
State/Province
Yeong-deungpo-Dong
ZIP/Postal Code
150-719
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27689789
Citation
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.
Results Reference
background
PubMed Identifier
30616685
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. Erratum In: Trials. 2020 May 27;21(1):438.
Results Reference
result
Learn more about this trial
Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity
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