Effectiveness of Task-Oriented Rehabilitation With SaeboFlex Splint on Independence, Visual Motor Skills, and Depression in Stroke Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Beck Depression Inventory (BDI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke occurrence at least 6 months prior
- •Score of 23 or higher on the Standardized Mini Mental Test
- •Brunnstrom stage 2 or 3
- •Ability to maintain sitting balance
- •Active shoulder and elbow flexion of 15 degrees or more
- •Wrist extension with finger extension of 15 degrees or more
- •Active finger flexion up to 25% of a full fist position
排除标准
- •Presence of another neurological, orthopedic, or psychiatric problem causing activity limitation
- •Previous use of the method being studied
结局指标
主要结局
Beck Depression Inventory (BDI)
时间窗: Through study completion, an average of 1.5 year
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
Action Research Arm Test (ARAT)
时间窗: Through study completion, an average of 1.5 year
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
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
时间窗: Through study completion, an average of 1.5 year
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
Barthel Index (BI)
时间窗: Through study completion, an average of 1.5 year
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
Fugl-Meyer Assessment for Upper Extremity
时间窗: Through study completion, an average of 1.5 year
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
Joint Range of Motion
时间窗: Through study completion, an average of 1.5 year
Goniometry is used to assess joint range of motion of the trunk, and flexion and extension degrees are recorded.
次要结局
- Brunnstrom Stages(Before intervention for inclusion stage)
- Mini-Mental State Examination (MMSE)(Before intervention for inclusion stage)
- Stroke Impact Scale (SIS)(Before intervention for inclusion stage)
研究者
Başar Öztürk
Assoc. Prof.
Fenerbahce University