The Effects of Gait Performance and Brain Activity After Robot-assisted Gait Training (RAGT) On Patients With Lower Extremity Thermal Injury

Gait Disorder, Sensorimotor Clinical Trial

Official title:

The Effects of Gait Performance and Brain Activity After Robot-assisted Gait Training (RAGT) On Patients With Lower Extremity Thermal Injury : a Prospective, Randomized, Single-blinded Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05988905
• Other study ID #: HangangSHH-17
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: August 2023
• Source: Hangang Sacred Heart Hospital
• Contact: Sung Rakyum
• Phone: 82-2-2639-5900
• Email: sung6652[@]hallym.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gait enables individuals to move forward and is considered a natural skill. Gait disturbances are very common in patients with burn injury. Major causes of gait disturbances are pain and joint contractures. Recent studies focused on the application of robot-assisted gait training (RAGT) for improving gait functions. This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn. To investigate the clinical effects, the investigators compare the results of RAGT group to the results of matched conventional (CON) rehabilitation group.This single-blinded, randomized, controlled trial involved 40 patients with lower extremity burns. Patients were randomized into a RAGT or a CON group. SUBAR® (CRETEM, Korea) is a exoskeletal-robot with a footplate that assists patients to perform gait motions. 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 8 weeks. The CON group focused on gait training such as active range of motion (ROM) exercise, weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min once a day for 5 days a week for 8 weeks.A wearable functional near-infrared spectroscopy (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical activity has not previously been documented in patients with burn injury. The primary outcome was the prefrontal cortical activity in the both groups. The walking-related cortical activity using an fNIRS device before and after 8 weeks training were measured. To evaluate functional recovery, functional ambulation category (FAC) scores and 6-minute walking test (6MWT) distances were measured. 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.

Description:

Gait enables individuals to move forward and is considered a natural skill. Gait disturbances are very common in patients with burn injury. Major causes of gait disturbances are pain and joint contractures. Recent studies focused on the application of robot-assisted gait training (RAGT) for improving gait functions. This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn. To investigate the clinical effects, the investigators compare the results of RAGT group to the results of matched conventional (CON) rehabilitation group.This single-blinded, randomized, controlled trial involved 40 patients with lower extremity burns. Patients were randomized into a RAGT or a CON group. SUBAR® (CRETEM, Korea) is a exoskeletal-robot with a footplate that assists patients to perform gait motions. 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 8 weeks. The CON group focused on gait training such as active range of motion (ROM) exercise, weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min once a day for 5 days a week for 8 weeks.A wearable functional near-infrared spectroscopy (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical activity has not previously been documented in patients with burn injury. The primary outcome was the prefrontal cortical activity in the both groups. The walking-related cortical activity using an fNIRS device before and after 8 weeks training were measured. To evaluate functional recovery, functional ambulation category (FAC) scores and 6-minute walking test (6MWT) distances were measured. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients with full or virtually full thickness involvement of >50% on the body surface area of the bilateral lower extremity
• age > 18 years
• with =1 functional ambulation category (FAC) score = 3

Exclusion Criteria:

• patients with 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 RAGT and conventional rehabilitation
• patients with severe pain who were unable to undergo conventional rehabilitation programs

Related Conditions & MeSH terms

• Gait Disorder, Sensorimotor
• Gait Disorders, Neurologic

Intervention

Other:
• robot assited gati training
SUBAR® (CRETEM, Korea) is a exoskeletal-robot with a footplate that assists gait movements. The patient's thigh length and lower leg length were measured before training, so that the SUBAR® can be adjusted to patient's size to ensure accurate training. During training, the therapist facilitated the treatment and stood by the patients' side to adjust the direction and speed. RAGT is programmed automatically, and it can be performed regularly over a long period. The patients received 30 min of robot-assisted training using SUBAR® once a day for 5 days a week for 8 weeks. Each training session lasted up to 40 min.
• conventional traiing
Patients also received conventional exercise rehabilitation with the same duration and frequency. Conventional rehabilitation therapy, which consisted of active assistive knee exercises, knee stretching, patellar mobilization exercises, and quadriceps setting exercises, was performed every day throughout the rehabilitation period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital

References & Publications (2)

Hawkins KA, Fox EJ, Daly JJ, Rose DK, Christou EA, McGuirk TE, Otzel DM, Butera KA, Chatterjee SA, Clark DJ. Prefrontal over-activation during walking in people with mobility deficits: Interpretation and functional implications. Hum Mov Sci. 2018 Jun;59:4 — View Citation

Knaepen K, Mierau A, Swinnen E, Fernandez Tellez H, Michielsen M, Kerckhofs E, Lefeber D, Meeusen R. Human-Robot Interaction: Does Robotic Guidance Force Affect Gait-Related Brain Dynamics during Robot-Assisted Treadmill Walking? PLoS One. 2015 Oct 20;10( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	near infrared spectroscopy	The rest period before gait period served as a baseline reference for osyhemoglobin of PFC perfusion. Cortical activity was measured by evaluating relative changes in oxyhemoglobin level and deoxyhemoglobin level.	8 weeks
Secondary	numeric rating scale (NRS)	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.	8 weeks
Secondary	functional ambulatory category	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.	8 weeks
Secondary	6 minutes walking test	Patients were instructed to walk as far as possible in 6 min	8 weeks