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

Fenerbahce University

Status: Completed

Conditions: Stroke; Splints; Depression

Treatments: Device: Saebo splint

Study type: Interventional

Funder types: Other

Identifiers

NCT06569654

fztbasarozturk

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Presence of another neurological, orthopedic, or psychiatric problem causing activity limitation
• Previous use of the method being studied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group received additional task-oriented repetitive training using the SaeboFlex orthosis, a dynamic wrist-hand-finger orthosis designed to facilitate upper limb rehabilitation in stroke participants. The SaeboFlex orthosis is a custom-fabricated, non-electric mechanical device that assists participants with significant upper extremity weakness, particularly those without active finger extension, in performing repetitive task practice

Treatment:

Device: Saebo splint

Control group

No Intervention group

Description:

Both the control and intervention groups received regular rehabilitation, which included physical therapy, occupational therapy and visual cognitive rehabilitation. During the regular rehabilitation program, participants received a comprehensive range of therapies aimed at improving their overall functional abilities and quality of life. The key components of the regular rehabilitation included: