Task-Oriented Rehab With SaeboFlex: Impact on Independence, Visual Motor Skills, and Depression in Stroke Patients
NCT Number: NCT06569654
Acronym: Randomized
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Depression|Splints
Interventions: DEVICE: Saebo splint
Sponsor: Fenerbahce University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-02-10
Completion Date: 2023-06-15
Locations: Fenerbahçe University, Istanbul, Turkey

Summary:
Objective: The SaeboFlex orthosis is designed to assist individuals with upper extremity weakness in performing repetitive tasks. This study is planned to evaluate its effectiveness in improving upper extremity functions in stroke patients.

Methods: A randomized controlled study is planned to be conducted with 30 stroke patients, who will be divided into a control group (15 patients) and an intervention group (15 patients). The intervention group will receive task-oriented training with the SaeboFlex splint for 12 weeks, twice a week for 45 minutes, in addition to regular rehabilitation. The control group will continue with standard rehabilitation. Planned outcome measures include the Brunnstrom Stages, Stroke Impact Scale, Fugl-Meyer Assessment, Action Research Arm Test, joint range of motion, and Beck Depression Inventory. Non-parametric tests will be used for statistical analysis.

Primary Outcome Measures: Action Research Arm Test (ARAT), The ARAT is a widely used, validated, and reliable measure of upper extremity function. It includes four subscales: grip, grasp, pinch, and gross motor movements. The highest total score is 57, indicating the best performance, Through study completion, an average of 1.5 year|Joint Range of Motion, Goniometry is used to assess joint range of motion of the trunk, and flexion and extension degrees are recorded., Through study completion, an average of 1.5 year|Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), The LOTCA test is used to evaluate individuals' cognitive abilities before and after intervention. It consists of 22 items grouped into two assessments: pre-treatment and post-treatment. The test assesses orientation, visual-spatial perception, visual-motor organization, thinking skills, and attention. Performance on each subtest and total scores are calculated. In our study, we evaluated only the visual-motor organization and visual-spatial perception parameters, Through study completion, an average of 1.5 year|Beck Depression Inventory (BDI), This 21-item scale is used to assess the level of depression. Each question is scored from 0 to 3, resulting in a total score ranging from 0 to 63. Scores between 0-13 indicate no depression, 14-24 indicate moderate depression, and scores above 25 indicate severe depression. The scale has been validated and adapted for the Turkish population, Through study completion, an average of 1.5 year|Barthel Index (BI), The Barthel Index, developed by Barthel and Mahoney in 1965, is a reliable and valid instrument used to assess individuals' independence in activities of daily living. In this study, the index was used to determine the level of independence in daily activities. The index scores range from 0 to 100, with scores of 0-20 indicating complete dependence, 21-61 indicating severe dependence, 62-90 indicating moderate dependence, 91-99 indicating mild dependence, and 100 indicating independence, Through study completion, an average of 1.5 year|Fugl-Meyer Assessment for Upper Extremity, This quantitative impairment index measures sensorimotor recovery following stroke based on Twitchell and Brunnstrom's motor recovery stages. The assessment evaluates motor function, balance, sensation, joint range of motion, and pain across five domains. The total score is 226, and the motor score ranges from 0 to 100. The assessment measures reflex movements of the shoulder, elbow, forearm, wrist, hand, hip, knee, and ankle. The highest score for the upper extremity is 66, and for the lower extremity is 34, Through study completion, an average of 1.5 year
Secondary Outcome Measures: Brunnstrom Stages, This test evaluates motor development in stroke patients and defines it into 6 stages. The absence of voluntary movement is categorized as stage 1 (flaccid stage), while the presence of isolated movements is considered stage 6. Evaluation is performed separately for the upper extremity, lower extremity, and hand, Before intervention for inclusion stage|Mini-Mental State Examination (MMSE), This screening test is used to assess the cognitive status of the participants. It consists of 11 items grouped into 5 main categories: orientation, registration, attention and calculation, recall, and language. Scores range from 0 to 30, with higher scores indicating better cognitive function. The validity and reliability of the test have been established in the Turkish population, Before intervention for inclusion stage|Stroke Impact Scale (SIS), This scale assesses the perception of post-stroke quality of life by patients or their caregivers. It consists of 8 subscales and 59 questions. Each question is rated on a 5-point Likert scale, indicating the level of difficulty experienced in the past week. Scores range from 0 to 100 for each subscale, and the SIS also includes an evaluation of post-stroke recovery perception using a visual analog scale (0: No recovery, 100: Complete recovery). The scale has been validated and adapted for the Turkish population, Before intervention for inclusion stage