Clinical trial NCT06569654: Task-Oriented Rehab With SaeboFlex: Impact on Independence, Visual Motor Skills, and Depression in Stroke Patients
Official title: Effectiveness of Task-Oriented Rehabilitation With SaeboFlex Splint on Independence, Visual Motor Skills, and Depression in Stroke Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Depression
Splints
Keywords: Occupational therapy
Activities daily living
Neurorehabilitation
Lead sponsor: Fenerbahce University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Through study completion, an average of 1.5 year
measure: Joint Range of Motion
timeFrame: Through study completion, an average of 1.5 year
measure: Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
timeFrame: Through study completion, an average of 1.5 year
measure: Beck Depression Inventory (BDI)
timeFrame: Through study completion, an average of 1.5 year
measure: Barthel Index (BI)
timeFrame: Through study completion, an average of 1.5 year
measure: Fugl-Meyer Assessment for Upper Extremity
timeFrame: Through study completion, an average of 1.5 year
Secondary outcomes:
measure: Brunnstrom Stages
timeFrame: Before intervention for inclusion stage
measure: Mini-Mental State Examination (MMSE)
timeFrame: Before intervention for inclusion stage
measure: Stroke Impact Scale (SIS)
timeFrame: Before intervention for inclusion stage
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fenerbahçe University
Study officials:
References: