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

NCT ID: NCT06569654

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2023-06-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Saebo splint

Intervention Type: DEVICE

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

Control group

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:

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Task-Oriented Repetitive Training

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fenerbahce University

OTHER

Sponsor Role: lead

Responsible Party

Başar Öztürk

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fenerbahçe University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

fztbasarozturk

Identifier Type: -

Identifier Source: org_study_id