Robot-Assisted Gait Training With Self-Observation in Stroke Rehabilitation

Sahmyook University

Status: Not yet enrolling

Conditions: Stroke

Treatments: Behavioral: experimental 2 group; Behavioral: experimental 1 group

Study type: Interventional

Funder types: Other

Identifiers

NCT06476327

SYU 2024-05-017

Details and patient eligibility

About

The aim of this study is to investigate the effects of robot-assisted gait training Concurrent with self-observation training on balance, gait, and cognitive function in stroke participants. The main question it aims to answer is:

Does robot-assisted gait training combined with self-observation improve balance abilities in stroke participants?

Participants will be

Group 1 Perform robot-assisted gait training combined with self-observation five times a week for four weeks.

Group 2 Perform robot-assisted gait training five times a week for four weeks.

All groups perform for 30 minutes per session.

Enrollment: 20 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who have had a stroke for more than 6 months but less than 1 year
• Functional Ambulation Category (FAC) ≥ 2
• Able to walk 10 meters independently with or without an assistive device
• Participants eligible for application of the robot (ANGEL LEGS M20, Anger Robotics)

Exclusion criteria

• Inability to wear the robot due to open wounds or skin conditions
• Severe cognitive impairment (MMSE-K < 10) or significant difficulty in communication due to language disorders
• Spasticity of the paralyzed limb with a Modified Ashworth Scale (MAS) ≥ 2
• High risk of fractures, such as osteoporosis
• Severe cardiovascular or pulmonary diseases
• Neurological disorders affecting gait function, such as Parkinson's disease or multiple sclerosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

experimental 1 group

Active Comparator group

Description:

Robot-Assisted Gait with Self-Observation

Treatment:

Behavioral: experimental 1 group

experimental 2 group

Active Comparator group

Description:

Robot-Assisted Gait

Treatment:

Behavioral: experimental 2 group