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

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.

Study Overview

• Status: Recruiting
• Conditions: Burns; Rehabilitation; Gait Training
• Intervention / Treatment: Other: robot assisted gait training; Other: conventional gait training

Detailed Description

Patients with burn injuries to the lower extremities experience gait dysfunctions due to pain or joint contractures, and gait asymmetry occurs due to complications on the affected side. The persisting gait asymmetry placed these patients at risk for potential negative consequences, such as loss of bone mineral density of the affected side, overuse injury on the unaffected side due to compensatory actions, compromised postural control, and gait inefficiencies. Early gait training through physical therapy is a pivotal strategy for enhancing patients' quality of life, functional outcomes and mitigating burn-related complications. The conventional physical therapy is instrumental in fostering an increased range of motion (ROM) and mitigating contractures following burns or skin grafts. Physical therapy centers on patients' positioning, ROM, muscles strength, endurance, balance, coordination, and respiratory rehabilitation.Previous studies using end-effector type RAGT for patients with gait disturbances have demonstrated that RAGT combined with conventional physiotherapy could significantly improved walking speed, gait performance, and motor power . 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sung Rakyum; Phone Number: 82-2-2639-5900; Email: sung6652@hallym.or.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07247
    • Recruiting
    • Hangang sacred heart hodpital
    • Contact: Ragyem Sung; Phone Number: 82-10-5939-2541; Email: sung6652@hallym.or.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: robot assisted gait training; 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; 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: conventional gait training; 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).
Active Comparator: conventioanl gait training; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional ambulatory category	Ambulatory ability was rated by using the functional ambulatory category (FAC) scale.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walking test	6MWT was performed in accordance with the standardised guidelines, and the walking course was 20 m. Patients were instructed to walk as far as possible in 6 min	8 weeks
gait parameters(cadence)	steps/minutes	8 weeks
gait parameters(gait speed)	Measure walking speed	8 weeks
gait parameters(step length)	Measure the distance between steps	12 weeks

Collaborators and Investigators

• Sponsor: Hangang Sacred Heart Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: burns; robot assisted gait training; gait pattern
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: HangangSHH-20

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