Effect on Gait Pattern During Robot Assisted Gait Training (RAGT) of End-effector Type in Burn Patients

NCT06564090 | Recruiting DMC

• 1 other identifier: HangangSHH-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate gait pattern and muscles power improvement of patient with gait disturbance caused by burns after end-effector type robot (Morning Walk®)-assited gait training (RAGT). This study randomly assigned 36 patients to one of two group : 30 minutes of Morning Walk® training with 30 minutes conventional physiotherapy (RAGT group) or 60 minutes of conventional physiotherapy (CON group). Five training sessions per week were given for 8 weeks. The primary outcomes were gait performance and muscles powers, which were assessed by the functional ambulation category (FAC) and the manual muscles test (MMT), respectively. The secondary outcomes included 6-minute walking test (6MWT), gait kinematic and spatiotemporal gait parameters. The results of this study is anticipated that the patients with gait disturbance receiving the RAGT might improve greater in gait performance and normal gait patterns that those trained with conventional physiotherapy.

Conditions

Burns; Gait Training; Rehabilitation

Keywords

burns; gait pattern; robot assisted gait training

Outcome Measures

Primary Outcomes (1)

• functional ambulatory category

  Ambulatory ability was rated by using the functional ambulatory category (FAC) scale.

  8 weeks

Secondary Outcomes (4)

• 6 minute walking test

  8 weeks

• gait parameters(cadence)

  8 weeks

• gait parameters(gait speed)

  8 weeks

• gait parameters(step length)

  12 weeks

Study Arms (2)

robot assisted gait training

EXPERIMENTAL

Morning Walk® is a new end-effector type robot developed by Hyundai Heavy Industries and Taeha Mechatronics for lower limb rehabilitation in the patients with gait disturbance.The RAGT group received RAGT with robot training for 30 minutes and conventional physiotherapy for 30 minutes per session

Other: robot assisted gait training; Other: conventional gait training

conventioanl gait training

ACTIVE COMPARATOR

The control group received conventional physiotherapy for 60 minutes per session. Conventional physiotherapy consisted of 30 minutes of therapist-assisted gait and balance training and 30 minutes of strengthening exercises. The both group patients received five training sessions per week for 8 weeks (a total of 40 sessions).

Other: conventional gait training

Interventions

robot assisted gait training OTHER

Morning Walk® is a new end-effector type robot developed by Hyundai Heavy Industries and Taeha Mechatronics for lower limb rehabilitation in the patients with gait disturbance.The RAGT group received RAGT with robot training for 30 minutes and conventional physiotherapy for 30 minutes per session.

robot assisted gait training

conventional gait training OTHER

The control group received conventional physiotherapy for 60 minutes per session. Conventional physiotherapy consisted of 30 minutes of therapist-assisted gait and balance training and 30 minutes of strengthening exercises. The both group patients received five training sessions per week for 8 weeks (a total of 40 sessions).

conventioanl gait training; robot assisted gait training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent split thickness skin graft (STSG) at Hangang Sacred Heart Hospital
• with full or virtually full thickness involvement ( \>50% of the body surface area of the lower extremity)
• aged \>18 years
• with ≤ 1 functional ambulation category (FAC) score of ≤3 were included in this study.

You may not qualify if:

• who had fourth-degree burns (involving muscles, tendons, and bone injuries)
• severe communication disorders due to intellectual impairment and psychologic problems
• body weight \> 135kg or height \>195cm
• physical status that could limit physical therapy (severe deformity or contracture of limbs, open wounds, or pressure ulcers, severe osteoporosis).

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead

Study Sites (1)

Hangang sacred heart hodpital

Seoul, 07247, South Korea

RECRUITING

Related Publications (1)

• Ebid AA, Attalla AF, Ibrahim AR, Mohamdy HM. Effect of anti-gravity treadmill (Alter G) training on gait characteristics and postural stability in adult with healed burns: A single blinded randomized controlled trial. Burns. 2024 Feb;50(1):106-114. doi: 10.1016/j.burns.2023.09.004. Epub 2023 Sep 20.

  PMID: 37798213 RESULT

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Sung Rakyum

CONTACT

82-2-2639-5900; sung6652@hallym.or.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measurements, and data analysis were performed by trained and blinded outcome assessor who was not involved in the intervention. The outcome measures were evaluated before training and immediately after 8 weeks of training.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: August 15, 2023
• Primary Completion: December 15, 2024
• Study Completion: December 30, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)