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

Not Applicable
Not yet recruiting
Conditions
Stroke
Interventions
Behavioral: experimental 2 group
Behavioral: experimental 1 group
Registration Number
NCT06476327
Lead Sponsor
Sahmyook University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
20
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
experimental 2 groupexperimental 2 groupRobot-Assisted Gait
experimental 1 groupexperimental 1 groupRobot-Assisted Gait with Self-Observation
Primary Outcome Measures
NameTimeMethod
Balance abilityfrom enrollment to the end of treatment at 4 weeks

- 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.

Gait abilityfrom enrollment to the end of treatment at 4 weeks

-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.

Secondary Outcome Measures
NameTimeMethod
Cognitive abilityfrom enrollment to the end of treatment at 4 weeks

- Mini-Mental Status Examination-Korea, (MMSE-K)

Consists of memory, recall ability, attention, language skills, numerical ability, and constructional ability.

Memory has 10 points, registration has 3 points, attention and calculation have 5 points, recall has 3 points, language function has 7 points, and comprehension and judgment have 2 points, totaling six areas and twelve items

Trial Locations

Locations (1)

Chungdam hospital

🇰🇷

Seoul, Gangnam-gu, Korea, Republic of

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