StrokeRandomizedNCT06569654
Task-Oriented Rehab With SaeboFlex: Impact on Independence, Visual Motor Skills, and Depression in Stroke Patients
A study testing Saebo splint in people with Stroke and Depression, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke, Depression, Splints
- What is being tested?
- Saebo splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2022to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of another neurological, orthopedic, or psychiatric problem causing activity limitation
- Previous use of the method being studied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stroke, Depression, Splints
- Being tested
- Saebo splint
- Keywords
- Occupational therapy, Activities daily living, Neurorehabilitation
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saebo splintDevice
Also called Task-Oriented Repetitive Training
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1.5 year
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Before intervention for inclusion stage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start10 Feb 2022
- Primary completion20 Dec 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başar Öztürk, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569654
- Sponsor's protocol ID
- fztbasarozturk
- Acronym
- Randomized
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Task-Oriented Rehabilitation With SaeboFlex Splint on Independence, Visual Motor Skills, and Depression in Stroke Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06569654
- Acronym / sponsor ID
- Randomized / fztbasarozturk
- Conditions
- Stroke, Depression, Splints
- Keywords
- Occupational therapy, Activities daily living, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Saebo splintThe 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 |
| 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: |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of another neurological, orthopedic, or psychiatric problem causing activity limitation
- Previous use of the method being studied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saebo splintAlso: Task-Oriented Repetitive TrainingThe 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 | Device | Intervention group |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: Through study completion, an average of 1.5 year
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
Joint Range of Motion
Time frame: Through study completion, an average of 1.5 year
Goniometry is used to assess joint range of motion of the trunk, and flexion and extension degrees are recorded.
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
Time frame: Through study completion, an average of 1.5 year
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
Beck Depression Inventory (BDI)
Time frame: Through study completion, an average of 1.5 year
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
Barthel Index (BI)
Time frame: Through study completion, an average of 1.5 year
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
Fugl-Meyer Assessment for Upper Extremity
Time frame: Through study completion, an average of 1.5 year
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
3 secondary outcomes
Brunnstrom Stages
Time frame: Before intervention for inclusion stage
Mini-Mental State Examination (MMSE)
Time frame: Before intervention for inclusion stage
Stroke Impact Scale (SIS)
Time frame: Before intervention for inclusion stage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saebo splint in people with Stroke and Depression, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: Through study completion, an average of 1.5 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.