The Effect of Robot-assisted Gait Training in Individuals With Chronic Stroke
ConditionChronic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorBiruni University
About this trial
The aim of our study was to investigate the effect of robot-assisted gait training on quadriceps muscle thickness, balance and gait parameters in individuals with chronic stroke.
For these purposes:-Improving gait and balance functions of patients with chronic stroke,-Increasing functional independence in daily life with walking trainings-Increase lower extremity muscle thickness with walking training, To investigate the effects of robot-assisted gait training on quadriceps muscle thickness, balance and gait parameters in individuals with chronic stroke.-It is aimed to contribute to the literature in this field by transforming the results to be obtained as a result of the study into a scientific publication
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
a history of cerebrovascular accident at least 6 months ago;
a score of at least 20 on the mini mental test;
no botulinum toxin treatment for the last 3 months;
a score of 2 or above on the Functional Ambulation Scale;
Disqualifiers
presence of concomitant neurologic, orthopedic, cardiovascular disease and acute comorbidities
severe spasticity of lower extremity muscles, more than 2 on the Modified Ashworth Scale
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Gait Training
Other interventiononventional walking training group will be given 20 minutes of NMES, 20 minutes of weight transfer, stretching, mobilization, bobath exercises and 20 minutes of parallel bar walking exercises. Patients in both groups will be treated 3 days a week, 1 hour a day for 6 weeks.
Robotic Gait Training
Other interventionThe robot-assisted walking group will receive 20 minutes of NMES, 20 minutes of weight transfer, stretching,mobilization, bobath exercises and 20 minutes of robot-assisted walking exercises. Patients in both groups will be treated 3 days a week, 1 hour a day for 6 weeks
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Conventional Gait GroupActive comparator 1 intervention
Group B: Robotic Gait GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fugl Meyer Lower Extremity Assessment:
In this scale, reflexes, synergy-dependent or independent voluntary movement, coordination and speed are evaluated, with each item scoring Yazım alanları gerektiği kadar uzatılabilir 2 points. 0: Cannot complete movement/No active movement. 1: Partial movement. 2: Movement is completed/movements can be performed normally. The lowest clinically significant score in the Fugl-Meyer test is considered to be 6
Time frame
15 minutes2
Ten meter walk test
For this test, a 16-meter walking track is created with starting and ending points and the test is completed without considering the first 3 and last 3 meters of this track. When the patient starts walking, the stopwatch is started after the first three meters and the stopwatch is stopped at the end of the tenth meter. After the patient walks the last 3 meters, walking is terminated. The completion time of the test is recorded in seconds
Time frame
5 minutes3
Berg Balance Scale
The Berg Balance Scale (BBS) is a scale that includes 14 instructions and for each instruction, the patient's performance is observed and a score between 0-4 is given. A score of 0 is given when the patient cannot perform the activity at all, while a score of 4 is given when the patient completes the activity independently. The highest score is 56, with 0-20 points indicating impaired balance, 21-40 points indicating acceptable balance, and 41-56 points indicating good balance. The scale takes between 10 and 20 minutes to complete. It has been validated in patients with chronic stroke
Time frame
15 minutes4
Examination of muscle thickness by ultrasound
The muscle thickness of the quadriceps and tibialis anterior muscles on the hemiplegic and intact side will be measured and recorded by ultrasound before and after treatment.
Time frame
10 minutesSecondary outcomes
1
The Timed Up and Go Test
The Timed Up and Go Test is a simple, widely used and quick test to assess mobility, balance and fall risk. To perform the test, participants need to get up from a standard chair, walk comfortably to a location 3 meters away from the floor, turn around, walk back to the chair and sit down in the same chair. All steps of the test will be measured using a stopwatch
Time frame
5 minutes2
Stroke Specific Quality of Life Scale
This scale, which was created to assess the quality of life of people diagnosed with stroke, consists of 12 domains including 49 items and is scored with a five-point Likert scale. In determining the mean score of each domain of the scale, the scores obtained from all items belonging to the domain are summed and divided by the number of items belonging to the domain. The total score of the scale is calculated by dividing the sum of the average scores obtained from each domain by 12. A high scale score indicates a high quality of life
Time frame
15 minutesSponsors and contacts
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Source ClinicalTrials.gov