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

NCT06569654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-26

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Fenerbahce University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2022-12-20
Completion
2023-06-15

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06569654 on ClinicalTrials.gov