Clinical trial NCT06746415: The Effect of Robot-assisted Gait Training in Individuals With Chronic Stroke
Official title: The Effect of Robot-assisted Gait Training on Quadriceps Muscle Thickness, Balance and Gait Parameters in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stroke
Keywords: exercise
robotic gait training
balance
gait
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: The aim of this study was to investigate the effect of robot-assisted gait training on quadriceps muscle thickness, balance and gait parameters in individuals with chronic stroke.

Stroke refers to a neurological disorder caused by cerebrovascular damage. It is defined as a sudden brain attack that causes partial or complete brain dysfunction due to blockage or rupture of blood vessels of the brain. The primary symptom of stroke is hemiparesis. In addition, stroke negatively affects senses, motor function, perception, cognition and language, depending on location, etiology and infarct volume. One study reported that 85% of stroke patients had hemiparesis and more than 69% had upper limb dysfunction. Balance and gait disturbances are closely related in chronic stroke patients; balance is an İmportant determinant of walking ability and motor function. Impairments in the strength and standing balance of the paretic lower limb are consistently associated with gait performance. Changes in segmental transverse range of motion and coordination are associated with poor gait and balance abilities \[5\]. Research has shown a continuous relationship between quadriceps muscle thickness and gait parameters in chronic stroke patients. Sánchez-Sánchez (2019) found that reduced quadriceps muscle thickness was associated with a lower ability to produce maximal force and postural instability, especially in those with limited mobility in the community. It was showed that fewer muscle modules, which may be indicative of reduced muscle thickness, were associated with poorer gait quality. A study found that decreased quadriceps muscle thickness and increased intramuscular fat were associated with decreased gait independence.These findings suggest that maintaining or improving quadriceps muscle thickness may be important in improving gait performance in chronic stroke patients. Robot-assisted gait training has been frequently used in research in recent years and positive improvements in gait speed and stride length have been obtained. In some studies, it has been shown that there is no significant difference in gait compared to traditional treatment, only improving clinical scales more . In contrast, Aprile (2017) found that both robotic and traditional gait training improved clinical scales, but only the robotic group showed higher percentage changes in certain scales.However, no significant difference was found in gait analysis. Ronchi (2015) also showed no additional gains in gait rehabilitation with robotic therapy compared to conventional treatment.Therefore, although robotic gait training offers some benefits, more research is needed to determine the different or similar effects on balance, gait and lower extremity muscle thickness compared to traditional methods. 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. The following hypotheses will be examined in the study. H0: Robot-assisted gait training has no effect on quadriceps muscle thickness, balance and gait parameters in individuals with chronic stroke. H1: Robot-assisted gait training has an effect on quadriceps muscle thickness, balance and gait parameters in individuals with chronic stroke

Eligibility criteria: Inclusion Criteria:

* 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;
* a score of 3 or above on the Brunnstrom motor staging scale in terms of lower extremity recovery level

Exclusion Criteria:

* presence of concomitant neurologic, orthopedic, cardiovascular disease and acute comorbidities
* severe spasticity of lower extremity muscles, more than 2 on the Modified Ashworth Scale

Primary outcomes:
measure: Fugl Meyer Lower Extremity Assessment:
timeFrame: 15 minutes
measure: Ten meter walk test
timeFrame: 5 minutes
measure: Berg Balance Scale
timeFrame: 15 minutes
measure: Examination of muscle thickness by ultrasound
timeFrame: 10 minutes
measure: Gait Analysis with Kinovea
timeFrame: 10 minutes
Secondary outcomes:
measure: The Timed Up and Go Test
timeFrame: 5 minutes
measure: Stroke Specific Quality of Life Scale
timeFrame: 15 minutes
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Güzin Kaya Aytutuldu
state: Zeytinburnu
Study officials:
References:
citation: Chang JJ, Tung WL, Wu WL, Su FC. Effect of bilateral reaching on affected arm motor control in stroke--with and without loading on unaffected arm. Disabil Rehabil. 2006 Dec 30;28(24):1507-16. doi: 10.1080/09638280600646060.
citation: Yoo DH, Kim SY. Effects of upper limb robot-assisted therapy in the rehabilitation of stroke patients. J Phys Ther Sci. 2015 Mar;27(3):677-9. doi: 10.1589/jpts.27.677. Epub 2015 Mar 31.
citation: Lee KB, Lim SH, Kim YD, Yang BI, Kim KH, Lee KS, Kim EJ, Hwang BY. The contributions of balance to gait capacity and motor function in chronic stroke. J Phys Ther Sci. 2016 Jun;28(6):1686-90. doi: 10.1589/jpts.28.1686. Epub 2016 Jun 28.
citation: Hacmon RR, Krasovsky T, Lamontagne A, Levin MF. Deficits in intersegmental trunk coordination during walking are related to clinical balance and gait function in chronic stroke. J Neurol Phys Ther. 2012 Dec;36(4):173-81. doi: 10.1097/NPT.0b013e31827374c1.
citation: Sanchez-Sanchez ML, Ruescas-Nicolau MA, Carrasco JJ, Espi-Lopez GV, Perez-Alenda S. Cross-sectional study of quadriceps properties and postural stability in patients with chronic stroke and limited vs. non-limited community ambulation. Top Stroke Rehabil. 2019 Oct;26(7):503-510. doi: 10.1080/10749357.2019.1634360. Epub 2019 Jun 27.
citation: Shin J, An H, Yang S, Park C, Lee Y, You SJH. Comparative effects of passive and active mode robot-assisted gait training on brain and muscular activities in sub-acute and chronic stroke. NeuroRehabilitation. 2022;51(1):51-63. doi: 10.3233/NRE-210304.