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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stroke; Splints
• Intervention / Treatment: Device: Saebo splint

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Fenerbahçe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: Task-Oriented Repetitive Training
No Intervention: 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:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brunnstrom Stages	This test evaluates motor development in stroke patients and defines it into 6 stages. The absence of voluntary movement is categorized as stage 1 (flaccid stage), while the presence of isolated movements is considered stage 6. Evaluation is performed separately for the upper extremity, lower extremity, and hand	Before intervention for inclusion stage
Mini-Mental State Examination (MMSE)	This screening test is used to assess the cognitive status of the participants. It consists of 11 items grouped into 5 main categories: orientation, registration, attention and calculation, recall, and language. Scores range from 0 to 30, with higher scores indicating better cognitive function. The validity and reliability of the test have been established in the Turkish population	Before intervention for inclusion stage
Stroke Impact Scale (SIS)	This scale assesses the perception of post-stroke quality of life by patients or their caregivers. It consists of 8 subscales and 59 questions. Each question is rated on a 5-point Likert scale, indicating the level of difficulty experienced in the past week. Scores range from 0 to 100 for each subscale, and the SIS also includes an evaluation of post-stroke recovery perception using a visual analog scale (0: No recovery, 100: Complete recovery). The scale has been validated and adapted for the Turkish population	Before intervention for inclusion stage

Collaborators and Investigators

• Sponsor: Fenerbahce University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Occupational therapy; Neurorehabilitation; Activities daily living
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Stroke; Depression; Depressive Disorder
• Other Study ID Numbers: fztbasarozturk

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No