NCT03992547

Brief Summary

This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn. To investigate RAGT effects, we compare the results of RGAT group to the results of matched conventional(CON) rehabilitation group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

October 23, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

June 18, 2019

Last Update Submit

October 22, 2019

Conditions

Burns

Keywords

funcional near infrared spectroscopyRobot-assisted gait training

Outcome Measures

Primary Outcomes (3)

  • Functional ambulation category (FAC)

    FAC was evaluated based on six scales. 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.

    12 weeks intervention

  • 6-minute walking test (6MWT)

    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

    12 weeks intervention

  • Numeric rating scale (NRS) scores

    Numeric rating scale (NRS) 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.

    12 weeks intervention

Secondary Outcomes (1)

  • frontal lobe cortial activity

    12 weeks intervention

Study Arms (1)

robot assisted gait traing

EXPERIMENTAL

SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. RAGT enables training of automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR® and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 12 weeks.

Other: Robot-assisted Gait Training

Interventions

Robot-assisted Gait TrainingOTHER

SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. RAGT enables training of automatically programmed normal gait pattern.

robot assisted gait traing

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • the parients with lower extremity burn
  • ≤1 functional ambulation category (FAC) score ≤ 3

You may not qualify if:

  • cognitive disorders
  • intellectual impairment before burn injury
  • 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 robot assisted gait training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangang Sacred Heart Hospital

Seoul, Yeongdeungpo-Ku, 150-719,, South Korea

RECRUITING

Related Publications (2)

  • Gawaziuk JP, Peters B, Logsetty S. Early ambulation after-grafting of lower extremity burns. Burns. 2018 Feb;44(1):183-187. doi: 10.1016/j.burns.2017.07.005. Epub 2017 Aug 5.

    PMID: 28789801BACKGROUND

  • Bae YH, Ko YJ, Chang WH, Lee JH, Lee KB, Park YJ, Ha HG, Kim YH. Effects of Robot-assisted Gait Training Combined with Functional Electrical Stimulation on Recovery of Locomotor Mobility in Chronic Stroke Patients: A Randomized Controlled Trial. J Phys Ther Sci. 2014 Dec;26(12):1949-53. doi: 10.1589/jpts.26.1949. Epub 2014 Dec 25.

    PMID: 25540505BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

SO YOUNG JOO, M.D.

CONTACT

+82-2-2639-5735anyany98@hallym.or.kr

Cheong Hoon Seo, M.D.

CONTACT

+82 2 2639 5738chseomd@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 20, 2019

Study Start

September 16, 2019

Primary Completion

July 30, 2020

Study Completion

October 31, 2020

Last Updated

October 23, 2019

Record last verified: 2019-06

Locations

KR(1)