Clinical trial NCT06564090: Effect on Gait Pattern During Robot Assisted Gait Training (RAGT) of End-effector Type in Burn Patients
Official title: Effect on Gait Pattern During Robot Assisted Gait Training (RAGT) of End-effector Type in Burn Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns
Gait Training
Rehabilitation
Keywords: burns
gait pattern
robot assisted gait training
Lead sponsor: Hangang Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: functional ambulatory category
timeFrame: 8 weeks
Secondary outcomes:
measure: 6 minute walking test
timeFrame: 8 weeks
measure: gait parameters(cadence)
timeFrame: 8 weeks
measure: gait parameters(gait speed)
timeFrame: 8 weeks
measure: gait parameters(step length)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hangang sacred heart hodpital
Study officials:
References:
citation: 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.