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

NCT06569654 | Completed

• 1 other identifier: fztbasarozturk
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Occupational therapy; Activities daily living; Neurorehabilitation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Device: Saebo splint

Control group

NO INTERVENTION

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:

Interventions

Saebo splint 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

Also known as: Task-Oriented Repetitive Training

Intervention group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Fenerbahçe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Depression

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 26, 2024
• Study Start: February 10, 2022
• Primary Completion: December 20, 2022
• Study Completion: June 15, 2023
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

TU (1)