Investigation of the Effects of Visual-Motor Based Training on Upper Extremity Functions in Individuals With Stroke

NCT ID: NCT07055945

Last Updated: 2025-09-04

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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-28

Study Completion Date

2025-12-30

Brief Summary

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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

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
A single-blind study was designed in which the patients would be unaware of their group allocation

Study Groups

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Visual-motor based training and physiotherapy program

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.

Group Type EXPERIMENTAL

Experimental group

Intervention Type OTHER

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).

Physiotherapy group

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.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

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.

Interventions

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Experimental group

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).

Intervention Type OTHER

Control group

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Previous upper extremity or thoracic surgery
* Vision problems related to stroke (hemianopsia)
* Color blindness
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baskent University Ankara Hospital

OTHER

Sponsor Role collaborator

Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Ayşegül Aykul

Principal Investigator, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sevgi İkbali Afşar, Prof Dr

Role: STUDY_DIRECTOR

Baskent University

Locations

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Başkent University

Ankara, Türkiye, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ayşegül Aykul, MSc

Role: CONTACT

+905444603250

Zeliha Özlem Yürük, Prof Dr

Role: CONTACT

+905323272755

Facility Contacts

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Ayşegül Aykul, MSc

Role: primary

+905444603250

Özlem Yürük, Prof Dr.

Role: backup

+905323272755

Other Identifiers

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BUAYKUL-001

Identifier Type: -

Identifier Source: org_study_id

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