The Effect of Robot-assisted Gait Training in Individuals With Chronic Stroke

NCT ID: NCT06746415

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-12-15

Brief Summary

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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

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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

Conditions

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Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional Gait Group

Conventional 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.

Group Type ACTIVE_COMPARATOR

Conventional Gait Training

Intervention Type OTHER

onventional 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 Group

. The 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.

Group Type EXPERIMENTAL

Robotic Gait Training

Intervention Type OTHER

The 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

Interventions

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Conventional Gait Training

onventional 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.

Intervention Type OTHER

Robotic Gait Training

The 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biruni University

OTHER

Sponsor Role lead

Responsible Party

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Guzin Kaya Aytutuldu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Güzin Kaya Aytutuldu

Istanbul, Zeytinburnu, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Güzin Kaya Aytutuldu

Role: CONTACT

05366265884

References

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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.

Reference Type BACKGROUND
PMID: 17178614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25931706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27390395 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23095903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31246150 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35311717 (View on PubMed)

Other Identifiers

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Biruni.Uni

Identifier Type: -

Identifier Source: org_study_id

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