NCT06569654

Task-Oriented Rehab With SaeboFlex: Impact on Independence, Visual Motor Skills, and Depression in Stroke Patients

Effectiveness of Task-Oriented Rehabilitation With SaeboFlex Splint on Independence, Visual Motor Skills, and Depression in Stroke Patients: A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fenerbahce University · Academic / Other
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Depression
• Splints

Interventions

Type	Name	Description
DEVICE	Saebo splint	The SaeboFlex orthosis was fitted individually for each participant in the intervention group. The orthosis was adjusted to ensure proper alignment and comfort. Participants were instructed on how to don and doff the orthosis correctly and safely. The orthosis positions the wrist and fingers in extension in preparation for grasp and release activities, enabling participants to perform functional tasks despite limited voluntary movement. Task-Oriented Repetitive Training: The intervention consisted of 45-minute sessions, conducted twice a week, over a period of 12 weeks. Each session focused on repetitive, task-oriented exercises designed to improve motor function and enhance neuroplasticity. Training Activities: * Moving the Ball * Bringing the Ball to the Mouth * Reaching Towards a Target * Manipulating the Ball Around a Target * Placing the Ball into Tubes * Throwing the Ball * Catching a Rolling Ball

Timeline

• Start date: 2022-02-10
• Primary completion: 2022-12-20
• Completion: 2023-06-15
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: Turkey (Türkiye)