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

NCT04281394 | Completed DMC

• 1 other identifier: HangangSHH-8
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Gait Disorder, Sensorimotor

Keywords

burns; rehabilitation; robot assisted gait training

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• the changes of active range of motion of flexion and extension

  baseline, and after 12 weeks intervention

• the changes of active range of motion of flexion and extension

  baseline, and after 12 weeks intervention

• the changes of active range of motion of dorsiflexion and plantarflexion

  baseline, and after 12 weeks intervention

• the changes of isometric forces of knee flexion and knee extension

  baseline, and after 12 weeks intervention

• the changes of isometric forces of ankle dorsiflexion and ankle plantarflexion

  baseline, and after 12 weeks intervention

Study Arms (2)

Robot assisted gait training

EXPERIMENTAL

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

conventional physical training group

ACTIVE COMPARATOR

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

Interventions

Robot assisted gait training DEVICE

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.

Robot assisted gait training

conventional gait training OTHER

even level gait training and range of motion exercises

conventional physical training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead
• Ministry of Health, Republic of Korea: collaborator

Study Sites (1)

Hangang Sacred Heart Hospital

Seoul, Yeong-deungpo-Dong, 150-719, South Korea

Location

Related 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.

  PMID: 27689789 BACKGROUND

• 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.

  PMID: 30616685 RESULT

MeSH Terms

Conditions

Burns; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: February 24, 2020
• Study Start: October 25, 2019
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: February 26, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)