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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.
Age
45 - 65 years
Sex
ALL
Healthy Volunteers
No
Fenerbahçe University
Istanbul, Turkey (Türkiye)
Start Date
February 10, 2022
Primary Completion Date
December 20, 2022
Completion Date
June 15, 2023
Last Updated
August 26, 2024
30
ACTUAL participants
Saebo splint
DEVICE
Lead Sponsor
Fenerbahce University
NCT07371455
NCT07360600
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05093673