StrokeNCT07055945
Investigation of the Effects of Visual-Motor Based Training on Upper Extremity Functions in Individuals With Stroke
A study testing Experimental group in people with Stroke, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effects of visual-motor based training and physiotherapy program on upper extremity functions in individuals with stroke and to compare with physiotherapy program. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2025to 30 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 6 months have passed since the cerebrovascular event
- Aged between 18 and 75 years
- First-time stroke
- Scoring 24 or higher on the Standardized Mini Mental Test (SMMT)
- Upper extremity functioning at Stage 4 or above according to the Brunnstrom Staging
- Shoulder, elbow, wrist, and finger muscle tone at or below a score of 2 on the Modified ---Ashworth Scale (MAS)
- Shoulder joint range of motion of at least 120°
- Ability to stand independently
Who cannot join
- Presence of hemispatial neglect syndrome
- Ataxia due to posterior circulatory ischemia
- Bilateral involvement (bilateral hemiparesis)
- Botulinum toxin injection in the last three months
- Physiotherapy treatment within the last 6 months
- Orthopedic problems such as shoulder subluxation, shoulder pain, or contractures in the hand or wrist
Show all 9Show fewer
- Previous upper extremity or thoracic surgery
- Vision problems related to stroke (hemianopsia)
- Color blindness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başkent University
Ankara, Türkiye, 06490
Ayşegül Aykul, MSc, +905444603250, aysegulaykul@hotmail.com
Özlem Yürük, Prof Dr., +905323272755, bastug@baskent.edu.tr
About this study
The purpose of this study is to investigate the effects of visual-motor based training and physiotherapy program on upper extremity functions in individuals with stroke and to compare with physiotherapy program.
Read the detailed description
Stroke is a clinical syndrome characterized by the sudden onset of signs and symptoms due to a localized loss of cerebral function, in the absence of any apparent cause other than a vascular origin.More than 50% of patients experience various impairments and dependence on others following a stroke. One of the primary reasons for this condition is problems affecting the upper extremity.
The Light Trainer system allows for the repetitive and non-repetitive practice of an activity. It enables goal-oriented, active participation, providing an enjoyable experience that engages the whole body. The difficulty level can be adjusted and is tailored to the individual's response ability. With these features, it supports motor learning. Given these characteristics, the Light Trainer system is considered suitable for use in patients with sensory-motor-cognitive disorders, such as those with stroke, multiple sclerosis, and Parkinson's disease. A literature review reveals that task-oriented exercises and virtual reality are commonly used for visual-motor training; however, no studies have been found involving this new system
The first aim of this study is to investigate the effects of visual-motor based training and physiotherapy program on upper extremity functions in individuals with stroke and to compare with physiotherapy program.
The second aim of this study is to investigate the effects of visual-motor based training and physiotherapy program on cognitive functions and trunk in individuals with stroke and to compare with physiotherapy program.
- Conditions
- Stroke
- Being tested
- Experimental group, Control group
- Keywords
- Stroke, Physiotherapy Rehabilitation, Functionality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Individuals in both groups will receive a physiotherapy program for 3 sessions per week, 60 minutes per day, for a total of 8 weeks.The study consists of two groups: the experimental group and the control group. Both groups will receive a physiotherapy program of 3 sessions per week, each lasting 60 minutes, for a total of 8 weeks. Within the 60-minute physiotherapy session, patients from both groups will undergo 30 minutes of exercises based on the Neurodevelopmental Treatment (NDT) method. In addition, a 12-minute training session will be conducted using a light-based trainer system (Light Trainer® Exercise System).
Control groupOther
In addition to the full-body exercises mentioned, individuals in the control group will also receive upper extremity exercises based on the Neurodevelopmental Treatment approach. These exercises are as follows:
- Functional reaching activities at the table in a sitting position (e.g., pushing objects, wiping the table, touching various points)
- Ball sliding on the wall in a standing position
- Touching different targets on the wall in a standing position
- Drawing shapes on the wall in a standing position
These exercises will be performed bilaterally and on the hemiparetic side. The exercises will be given for approximately 12 minutes, in line with the exercises given to the experimental group. The difficulty level will not be increased during the training.
| Study group | Role | What they receive |
|---|---|---|
| Visual-motor based training and physiotherapy program | Experimental | The physiotherapy group will take a physiotherapy program for 3 sessions per week, 60 minutes per day, for a total of 8 weeks. The program will consist of functional exercises for trunk, upper and lower extremities.
In addition to the functional exercises individuals will receive visual-motor training targeting the upper extremity. This training will be conducted using the Light Trainer, a branded light-based training system. The light training system consists of 6 laser sensor-equipped blue, red, and green light emitters.The system is operated through a smartphone application.The training will utilize four different games, progressing from easy to difficult: Sequential, random standard, multiple light, and different color. Participants will receive training via a 12-minute session utilizing the Light Trainer device. Receives: Other: Experimental group |
| Physiotherapy group | Active comparator | The physiotherapy group will take a physiotherapy program for 3 sessions per week, 60 minutes per day, for a total of 8 weeks.
The program will consist of functional exercises for trunk, upper and lower extremities (same as experimental group).
Functional reaching activities at the table in a sitting position, ball sliding on the wall in a standing position, touching different targets on the wall in a standing position and drawing shapes on the wall in a standing position will also added to the program. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
Modified Ashworth Scale (MAS) will be used to evaluate the muscle tone of the shoulder, elbow, wrist, and finger flexors in post-stroke patients. This scale will be applied both as part of the initial assessment for determining eligibility and to evaluate the effectiveness of the intervention by comparing pre- and post-treatment scores. MAS grades muscle tone on a 6-point ordinal scale.Each measurement will be performed twice. Data will be entered into the statistical database both as ordinal values (0 to 4) and using a coding system for further analysis. Patients will be evaluated pre- and post-treatment using the MAS.
Measured: eight weeks
Fugl-Meyer Upper Extremity Assessment
The Fugl-Meyer Motor Assessment Scale is a performance-based motor impairment scale developed to evaluate recovery in individuals with stroke. This scale includes subtests that assess upper and lower extremity functions, balance, sensation, and posture. In our study, the upper extremity gross and fine motor functions of patients will be assessed using the Fugl-Meyer Upper Extremity (FM-UE) Assessment Scale. The maximum score that can be obtained in the assessment is 66, with higher scores indicating better motor function. Patients will be evaluated pre- and post-treatment using the Fugl-Meyer Assessment Scale.
Measured: eight weeks
Wolf Motor Function Test
The Wolf Motor Function Test (WMFT) is a test developed to evaluate motor skills in patients with moderate to severe upper extremity motor deficits The original version was developed by Wolf and colleagues. In our study, the modified version developed by Morris and colleagues will be used.Data will be collected for 15 activities in two areas: "functional ability" and "performance time". The duration of the test is 30-45 minutes.Each activity will be rated by the physiotherapist using a scale of 0 to 5 based on the functional ability section, where:0 = "The affected hand is not used at all during the activity",5 = "Normal movement".The average score for functional ability will be calculated, and based on this, the patient will receive a score between 0 and 5, with higher scores indicating good functional ability.The performance time will be recorded in seconds.The maximum time given to complete an activity is 120seconds.Patients will be evaluated pre- and post-treatment using the WMFT
Measured: eight weeks
Purdue Pegboard Test
The Purdue Pegboard Test(PPT) is used to assess the motor skills and coordination of the upper extremity. The test consists of a board with two parallel rows of 25 holes, along with pegs, rings, and small pins.In our study, upper extremity motor skills and coordination will be evaluated using the PPT. Scoring: Each pin inserted with the right or left hand earns 1 point, each pair of pins inserted with both hands earns 1 point, and each completed combination (pin, washer, and nut) is worth 4 points. Patients will be evaluated pre- and post-treatment using the PPT.
Measured: eight weeks
Secondary outcomes (3)
Cognitive functions: Stroop Test-Interference Form
The Stroop test is a cognitive assessment that evaluates executive functions and measures attention, the inhibition of inappropriate automatic responses, and perception under disruptive influence. The Stroop effect not only measures executive functions but also assesses processing speed, automatic, and parallel processing. The Stroop effect occurs when there is a conflict between the color name written and the color used to write it. When the colors are different, reading the word becomes slower compared to reading words that are written in the same color, and the difference between these two speeds is referred to as the Stroop effect. The Stroop effect not only measures executive functions but also assesses processing speed, automatic, and parallel processing. A longer completion time and a higher error count indicate weak cognitive flexibility. Patients will be evaluated pre- and post-treatment using the Stroop test.
Measured: eight weeks
Postural Assessment Scale for Stroke Patients
The Postural Assessment Scale for Stroke Patients (PASS) is designed to evaluate postural control and balance in detail. The scale assesses balance during tasks such as lying, sitting, standing, or changing positions. Each task is rated from 0 (lowest) to 3 (highest). The total score ranges from 0 to 36. Higher scores on the PASS indicate better postural stability and functional independence, with a maximum score of 36 representing full postural competence. Patients will be evaluated pre- and post-treatment using the PASS.
Measured: eight weeks
Trunk functions: Body Disorder Scale (BDS)
BDS is a tool used to assess motor dysfunctions resulting from stroke and to measure the quality of body movements. The scale consists of 17 parameters and is used to evaluate somatic, motor, and coordination deficits in stroke patients. The scale is divided into three subcategories: static sitting balance, dynamic sitting balance, and coordination. The total score ranges from 0 to 23 points, with higher scores indicating better performance. Patients will be evaluated pre- and post-treatment using the BDS.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start28 Aug 2025
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- The study consists of two groups: the visual-motor based training and physiotherapy program group and the physiotherapy program group. Both groups will receive a physiotherapy program for 60 minutes of 3 sessions per week for a total of 8 weeks. Patients from both groups will take 30 minutes of functional exercises. These exercises are fundamental and will be tailored to the individual needs of the patient. Light Trainer will be used for visual-motor based training in the experimental group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University Ankara Hospital
- Responsible party
- Principal investigator, Ayşegül Aykul, Baskent University
- Investigators
- Sevgi İkbali Afşar, Prof Dr, Study director, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055945
- Sponsor's protocol ID
- BUAYKUL-001
- Status last verified
- Aug 2025
- First submitted
- 7 May 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, because all patient data are subject to the Başkent Hospital's patient privacy policy.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Visual-Motor Based Training on Upper Extremity Functions in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT07055945
- Acronym / sponsor ID
- BUAYKUL-001
- Conditions
- Stroke
- Keywords
- Stroke, Physiotherapy Rehabilitation, Functionality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Baskent University Ankara Hospital
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of visual-motor based training and physiotherapy program on upper extremity functions in individuals with stroke and to compare with physiotherapy program.
Detailed description
Stroke is a clinical syndrome characterized by the sudden onset of signs and symptoms due to a localized loss of cerebral function, in the absence of any apparent cause other than a vascular origin.More than 50% of patients experience various impairments and dependence on others following a stroke. One of the primary reasons for this condition is problems affecting the upper extremity.
The Light Trainer system allows for the repetitive and non-repetitive practice of an activity. It enables goal-oriented, active participation, providing an enjoyable experience that engages the whole body. The difficulty level can be adjusted and is tailored to the individual's response ability. With these features, it supports motor learning. Given these characteristics, the Light Trainer system is considered suitable for use in patients with sensory-motor-cognitive disorders, such as those with stroke, multiple sclerosis, and Parkinson's disease. A literature review reveals that task-oriented exercises and virtual reality are commonly used for visual-motor training; however, no studies have been found involving this new system
The first aim of this study is to investigate the effects of visual-motor based training and physiotherapy program on upper extremity functions in individuals with stroke and to compare with physiotherapy program.
The second aim of this study is to investigate the effects of visual-motor based training and physiotherapy program on cognitive functions and trunk in individuals with stroke and to compare with physiotherapy program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study consists of two groups: the visual-motor based training and physiotherapy program group and the physiotherapy program group. Both groups will receive a physiotherapy program for 60 minutes of 3 sessions per week for a total of 8 weeks. Patients from both groups will take 30 minutes of functional exercises. These exercises are fundamental and will be tailored to the individual needs of the patient. Light Trainer will be used for visual-motor based training in the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Visual-motor based training and physiotherapy program | Experimental | Other: Experimental groupThe physiotherapy group will take a physiotherapy program for 3 sessions per week, 60 minutes per day, for a total of 8 weeks. The program will consist of functional exercises for trunk, upper and lower extremities. In addition to the functional exercises individuals will receive visual-motor training targeting the upper extremity. This training will be conducted using the Light Trainer, a branded light-based training system. The light training system consists of 6 laser sensor-equipped blue, red, and green light emitters.The system is operated through a smartphone application.The training will utilize four different games, progressing from easy to difficult: Sequential, random standard, multiple light, and different color. Participants will receive training via a 12-minute session utilizing the Light Trainer device. |
| Physiotherapy group | Active comparator | Other: Control groupThe physiotherapy group will take a physiotherapy program for 3 sessions per week, 60 minutes per day, for a total of 8 weeks. The program will consist of functional exercises for trunk, upper and lower extremities (same as experimental group). Functional reaching activities at the table in a sitting position, ball sliding on the wall in a standing position, touching different targets on the wall in a standing position and drawing shapes on the wall in a standing position will also added to the program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 6 months have passed since the cerebrovascular event
- Aged between 18 and 75 years
- First-time stroke
- Scoring 24 or higher on the Standardized Mini Mental Test (SMMT)
- Upper extremity functioning at Stage 4 or above according to the Brunnstrom Staging
Key exclusion criteria (9 listed)
- Presence of hemispatial neglect syndrome
- Ataxia due to posterior circulatory ischemia
- Bilateral involvement (bilateral hemiparesis)
- Botulinum toxin injection in the last three months
- Physiotherapy treatment within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupIndividuals in both groups will receive a physiotherapy program for 3 sessions per week, 60 minutes per day, for a total of 8 weeks.The study consists of two groups: the experimental group and the control group. Both groups will receive a physiotherapy program of 3 sessions per week, each lasting 60 minutes, for a total of 8 weeks. Within the 60-minute physiotherapy session, patients from both groups will undergo 30 minutes of exercises based on the Neurodevelopmental Treatment (NDT) method. In addition, a 12-minute training session will be conducted using a light-based trainer system (Light Trainer® Exercise System). | Other | Visual-motor based training and physiotherapy program |
| Control groupIn addition to the full-body exercises mentioned, individuals in the control group will also receive upper extremity exercises based on the Neurodevelopmental Treatment approach. These exercises are as follows: * Functional reaching activities at the table in a sitting position (e.g., pushing objects, wiping the table, touching various points) * Ball sliding on the wall in a standing position * Touching different targets on the wall in a standing position * Drawing shapes on the wall in a standing position These exercises will be performed bilaterally and on the hemiparetic side. The exercises will be given for approximately 12 minutes, in line with the exercises given to the experimental group. The difficulty level will not be increased during the training. | Other | Physiotherapy group |
Primary outcome
Modified Ashworth Scale
Time frame: eight weeks
Modified Ashworth Scale (MAS) will be used to evaluate the muscle tone of the shoulder, elbow, wrist, and finger flexors in post-stroke patients. This scale will be applied both as part of the initial assessment for determining eligibility and to evaluate the effectiveness of the intervention by comparing pre- and post-treatment scores. MAS grades muscle tone on a 6-point ordinal scale.Each measurement will be performed twice. Data will be entered into the statistical database both as ordinal values (0 to 4) and using a coding system for further analysis. Patients will be evaluated pre- and post-treatment using the MAS.
Fugl-Meyer Upper Extremity Assessment
Time frame: eight weeks
The Fugl-Meyer Motor Assessment Scale is a performance-based motor impairment scale developed to evaluate recovery in individuals with stroke. This scale includes subtests that assess upper and lower extremity functions, balance, sensation, and posture. In our study, the upper extremity gross and fine motor functions of patients will be assessed using the Fugl-Meyer Upper Extremity (FM-UE) Assessment Scale. The maximum score that can be obtained in the assessment is 66, with higher scores indicating better motor function. Patients will be evaluated pre- and post-treatment using the Fugl-Meyer Assessment Scale.
Wolf Motor Function Test
Time frame: eight weeks
The Wolf Motor Function Test (WMFT) is a test developed to evaluate motor skills in patients with moderate to severe upper extremity motor deficits The original version was developed by Wolf and colleagues. In our study, the modified version developed by Morris and colleagues will be used.Data will be collected for 15 activities in two areas: "functional ability" and "performance time". The duration of the test is 30-45 minutes.Each activity will be rated by the physiotherapist using a scale of 0 to 5 based on the functional ability section, where:0 = "The affected hand is not used at all during the activity",5 = "Normal movement".The average score for functional ability will be calculated, and based on this, the patient will receive a score between 0 and 5, with higher scores indicating good functional ability.The performance time will be recorded in seconds.The maximum time given to complete an activity is 120seconds.Patients will be evaluated pre- and post-treatment using the WMFT
Purdue Pegboard Test
Time frame: eight weeks
The Purdue Pegboard Test(PPT) is used to assess the motor skills and coordination of the upper extremity. The test consists of a board with two parallel rows of 25 holes, along with pegs, rings, and small pins.In our study, upper extremity motor skills and coordination will be evaluated using the PPT. Scoring: Each pin inserted with the right or left hand earns 1 point, each pair of pins inserted with both hands earns 1 point, and each completed combination (pin, washer, and nut) is worth 4 points. Patients will be evaluated pre- and post-treatment using the PPT.
3 secondary outcomes
Cognitive functions: Stroop Test-Interference Form
Time frame: eight weeks
Postural Assessment Scale for Stroke Patients
Time frame: eight weeks
Trunk functions: Body Disorder Scale (BDS)
Time frame: eight weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No. No, because all patient data are subject to the Başkent Hospital's patient privacy policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sevgi İkbali Afşar, Prof Dr study director
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Stroke, run by Baskent 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 8 inclusion and 9 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 4 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 Ayşegül Aykul, MSc (+905444603250, aysegulaykul@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: eight weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2025.