About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Presence of hemispatial neglect syndrome
Ataxia due to posterior circulatory ischemia
Bilateral involvement (bilateral hemiparesis)
Botulinum toxin injection in the last three months
Trial design
Parallel
Treatments tested in this trial
Experimental group
Other interventionIndividuals 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 group
Other interventionIn 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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
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.
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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Baskent University
Lead sponsor
Baskent University Ankara Hospital
Collaborator