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Chronic StrokeNCT06746415

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

A study testing Conventional Gait Training and Robotic Gait Training in people with Chronic Stroke, run by Biruni University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Chronic Stroke
What is being tested?
Conventional Gait Training and Robotic Gait Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2024to 15 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Güzin Kaya Aytutuldu contact

05366265884

guzinkaya14@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Güzin Kaya Aytutuldu

    Istanbul, Zeytinburnu, 34015

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Robot-assisted Gait Training on Quadriceps Muscle Thickness, Balance and Gait Parameters in Chronic Stroke Patients

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

Read the 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

Conditions
Chronic Stroke
Being tested
Conventional Gait Training, Robotic Gait Training
Keywords
exercise, robotic gait training, balance, gait
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Gait TrainingOther

    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 TrainingOther

    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

Study groups in NCT06746415
Study groupRoleWhat they receive
Conventional Gait GroupActive comparatorConventional 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.
Receives: Other: Conventional Gait Training
Robotic Gait GroupExperimental. 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.
Receives: Other: Robotic Gait Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 15 minutes

  2. 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

    Measured: 5 minutes

  3. 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

    Measured: 15 minutes

  4. 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.

    Measured: 10 minutes

  5. Gait Analysis with Kinovea

    Walking distances of 3 meters will be recorded with the camera to be placed on the sagittal. Colored marks will be placed on the right and left heels.

    The colored marks will be marked on the video and step lengths, walking speed and arm swing will be calculated with Kinovea motion analysis software. Several gait cycles will be recorded in the video and cadence (number of steps per minute), right and left step lengths will be expressed

    Measured: 10 minutes

Secondary outcomes (2)
  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

    Measured: 5 minutes

  2. 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

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2024
  2. Study start1 Dec 2024
  3. Primary completion15 Jan 2025
  4. Study completion15 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06746415
Sponsor's protocol ID
Biruni.Uni
Status last verified
Sep 2025
First submitted
18 Dec 2024
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17178614
  • 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.

    PubMed 25931706
  • 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.

    PubMed 27390395
  • 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.

    PubMed 23095903
  • 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.

    PubMed 31246150
  • 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.

    PubMed 35311717

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Gait Training and Robotic Gait Training in people with Chronic Stroke, run by Biruni University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Güzin Kaya Aytutuldu (05366265884, guzinkaya14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl Meyer Lower Extremity Assessment: (time frame: 15 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06746415, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

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