Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569654
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Task-Oriented Rehab With SaeboFlex Impact on Independence Visual Motor Skills and Depression in Stroke Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Task-Oriented Rehabilitation With SaeboFlex Splint on Independence Visual Motor Skills and Depression in Stroke Patients A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Randomized
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None