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

NCT ID: NCT06476327

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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experimental 1 group

Robot-Assisted Gait with Self-Observation

Group Type ACTIVE_COMPARATOR

experimental 1 group

Intervention Type 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 2 group

Robot-Assisted Gait

Group Type ACTIVE_COMPARATOR

experimental 2 group

Intervention Type 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.

Interventions

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experimental 1 group

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.

Intervention Type BEHAVIORAL

experimental 2 group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahmyook University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chungdam hospital

Seoul, Gangnam-gu, South Korea

Site Status

Countries

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South Korea

Central Contacts

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Hyeri Lee

Role: CONTACT

+82-10-6377-9341

Facility Contacts

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Hyeri Lee

Role: primary

+82-10-6377-9341

Other Identifiers

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SYU 2024-05-017

Identifier Type: -

Identifier Source: org_study_id

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