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

NCT06476327 | Not Yet Recruiting

• 1 other identifier: SYU 2024-05-017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

stroke; gait; cognitive function

Outcome Measures

Primary Outcomes (2)

• Balance ability

  \- Timed up and go test (TUG) Participants sit on a chair with armrests, rise upon hearing a starting signal, walk 3 meters, return, and sit back down. The speed of this task is measured. Participants may use usual walking aids (cane or walker) but should not receive physical assistance. \- Functional Reach Test (FRT) Participants stand against a wall with feet fixed vertically, arms raised to 90 degrees, reaching forward as far as possible while measuring the distance (in cm) from the tip of the third metacarpal bone.

  from enrollment to the end of treatment at 4 weeks

• Gait ability

  -10 meter walking test (10MWT) The walking speed is calculated by measuring the time (in seconds) takes for the subject to walk 10 meters. Instructed to walk a total of 14 meters at maximum speed, excluding the first 2 meters and the last 2 meters to account for acceleration and deceleration phases. Participants may use personal walking aids (cane, walker, etc.). -GAITRite system (CIR Systems Inc., Franklin, New Jersey, USA) Participants pass over an electronic gait mat to computationally measure temporal and spatial walking variables.

  from enrollment to the end of treatment at 4 weeks

Secondary Outcomes (1)

• Cognitive ability

  from enrollment to the end of treatment at 4 weeks

Study Arms (2)

experimental 1 group

ACTIVE COMPARATOR

Robot-Assisted Gait with Self-Observation

Behavioral: experimental 1 group

experimental 2 group

ACTIVE COMPARATOR

Robot-Assisted Gait

Behavioral: experimental 2 group

Interventions

experimental 1 group BEHAVIORAL

A camera is installed on the walker used in the training, and the recorded video is mirrored in real-time to a tablet computer. Participants can view this video through smart glasses connected to the tablet computer. A glasses strap will be used to secure the glasses, ensuring there is no interference with walking. Participants will undergo a total of 20 training sessions, five times a week for four weeks, with each session lasting 30 minutes. Participants will have a 4-minute break during the 30-minute gait training session. Participants will be given a period to adapt to wearing the robot, and after that, the intervention will be conducted based on each participant's individual abilities and adaptation.

experimental 1 group

experimental 2 group BEHAVIORAL

Participants will undergo a total of 20 training sessions, five times a week for four weeks, with each session lasting 30 minutes. Participants will have a 4-minute break during the 30-minute gait training session. Participants will be given a period to adapt to wearing the robot, and after that, the intervention will be conducted based on each participant's individual abilities and adaptation.

experimental 2 group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahmyook University: lead

Study Sites (1)

Chungdam hospital

Seoul, Gangnam-gu, 06063, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hyeri Lee

CONTACT

+82-10-6377-9341; hee03088@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)