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Clinical Trials/NCT06476327
NCT06476327
Not yet recruiting
Not Applicable

The Effects of Robot-Assisted Gait Training Concurrent With Self-Observation Training on Balance, Gait, Cognitive Function in Stroke

Sahmyook University1 site in 1 country20 target enrollmentJuly 2024
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Sahmyook University
Enrollment
20
Locations
1
Primary Endpoint
Balance ability
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2024
End Date
October 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Balance ability

Time Frame: from 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 ability

Time Frame: from 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 Outcomes

  • Cognitive ability(from enrollment to the end of treatment at 4 weeks)

Study Sites (1)

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