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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281394
• Other study ID #: HangangSHH-8
• Status: Completed
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: February 24, 2020

Study information

• Verified date: October 2019
• Source: Hangang Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 24, 2020
• Est. primary completion date: February 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burns
• Gait Disorder, Sensorimotor
• Gait Disorders, Neurologic

Intervention

Device:
• Robot assisted gait training
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.

Other:
• conventional gait training
even level gait training and range of motion exercises

Locations

Country	Name	City	State
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul	Yeong-deungpo-Dong

Sponsors (2)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital	Ministry of Health, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, and after 12 weeks intervention
Primary	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.	baseline, and after 12 weeks intervention
Primary	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	baseline, and after 12 weeks intervention
Secondary	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)	baseline, and after 12 weeks intervention
Secondary	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)	baseline, and after 12 weeks intervention
Secondary	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)	baseline, and after 12 weeks intervention
Secondary	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.	baseline, and after 12 weeks intervention
Secondary	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.	baseline, and after 12 weeks intervention
Secondary	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.	baseline, and after 12 weeks intervention
Secondary	the changes of center of foot pressure pattern	center of foot pressure patten during a normal stride. longitudinal line analysis	baseline, and after 12 weeks intervention