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

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.

Study Overview

• Status: Completed
• Conditions: Burns; Gait Disorder, Sensorimotor
• Intervention / Treatment: Device: Robot assisted gait training; Other: conventional gait training

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yeong-deungpo-Dong
    • Seoul, Yeong-deungpo-Dong, Korea, Republic of, 150-719
      • Hangang Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot assisted gait training; 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.	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.
Active Comparator: conventional physical training group; 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.	Other: conventional gait training; even level gait training and range of motion exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hangang Sacred Heart Hospital
• Collaborators: Ministry of Health, Republic of Korea

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2019
• Primary Completion (Actual): February 24, 2020
• Study Completion (Actual): February 24, 2020

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: rehabilitation; burns; robot assisted gait training
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Burns; Gait Disorders, Neurologic
• Other Study ID Numbers: HangangSHH-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No