Robot-Assisted Gait Training With Self-Observation in Stroke Rehabilitation
ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorSahmyook University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
experimental 1 group
BehavioralA 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
BehavioralParticipants 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: experimental 1 groupActive comparator 1 intervention
Group B: experimental 2 groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
from enrollment to the end of treatment at 4 weeks2
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.
Time frame
from enrollment to the end of treatment at 4 weeksSecondary outcomes
1
Cognitive ability
\- 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
Time frame
from enrollment to the end of treatment at 4 weeksSponsors and contacts
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Source ClinicalTrials.gov
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