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

NCT07055945 | Recruiting

• 1 other identifier: BUAYKUL-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Physiotherapy Rehabilitation; Functionality

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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

  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.

  eight weeks

Secondary Outcomes (3)

• Cognitive functions: Stroop Test-Interference Form

  eight weeks

• Postural Assessment Scale for Stroke Patients

  eight weeks

• Trunk functions: Body Disorder Scale (BDS)

  eight weeks

Study Arms (2)

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.

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.

Other: Control group

Interventions

Experimental group 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).

Visual-motor based training and physiotherapy program

Control group 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.

Physiotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead
• Baskent University Ankara Hospital: collaborator

Study Sites (1)

Başkent University

Ankara, Türkiye, 06490, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sevgi İkbali Afşar, Prof Dr

  Baskent University

  STUDY DIRECTOR

Central Study Contacts

Ayşegül Aykul, MSc

CONTACT

+905444603250; aysegulaykul@hotmail.com

Zeliha Özlem Yürük, Prof Dr

CONTACT

+905323272755; bastug@baskent.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A single-blind study was designed in which the patients would be unaware of their group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MSc

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: July 9, 2025
• Study Start: August 28, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)