Viewing Study NCT06286436



Ignite Creation Date: 2024-05-06 @ 8:10 PM
Last Modification Date: 2024-10-26 @ 3:22 PM
Study NCT ID: NCT06286436
Status: COMPLETED
Last Update Posted: 2024-05-16
First Post: 2024-02-22

Brief Title: Effect of Dual-task Training on the Number of EEG Band in Stroke Patients
Sponsor: Universidad de Zaragoza
Organization: Universidad de Zaragoza

Study Overview

Official Title: Effect of Dual-task Training on the Number of EEG Band in Stroke Patients
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Stroke is a prevalent global health concern causing widespread disability as it disrupts blood supply to the brain leading to functional impairments Upper limb dysfunction affects over 80 of stroke survivors acutely and becomes permanent in approximately 60 hindering daily activities and autonomy Dual-task training DTT involving simultaneous cognitive and motor tasks resembling daily activities is proposed as an effective intervention

The study suggests using electroencephalogram EEG analysis particularly the Fast Fourier Transform FFT to assess changes in brain signals pre- and post-DTT intervention EEG provides real-time insights into brain function and FFT analyzes signal frequencies The intervention involves three tasks performed concurrently with mental calculations such as sorting blocks and manipulating objects This 12-session four-week intervention aims to improve upper limb function The study explores EEGs role in evaluating DTT effects on stroke patients particularly using FFT to analyze brain signal frequencies
Detailed Description: Stroke is one of the most common diseases and causes of disability worldwide This condition occurs when the blood supply to the brain tissue is disrupted leading to ischaemia of the brain tissue and the functional impairments in the different systems of the body that this entails One of the most prevalent and disabling dysfunctions in stroke patients is that related to the upper limb with more than 80 experiencing this condition acutely and being permanent in approximately 60 of stroke survivors despite rehabilitation The alteration of the functionality of the upper limbs of the person after stroke including muscle weakness sensory disorders increased muscle tone and lack of neuromuscular control and coordination means that the person is not able to carry out normal activities of daily living ADLs thus affecting their autonomy and independence

Most ADLs often require a combination of cognitive and motor tasks at the same time These tasks are especially difficult for people who have suffered a stroke as their mental and physical capacity is impaired and therefore performing more than one task becomes a challenge On the other hand dual-task training DTT understood as a treatment method based on exercises involving 2 or more tasks at the same time related to the persons ADLs can be a interesting approach to improve the above mentioned upper limb disorders

One of the tools recommended to analyse how a treatment or intervention affects the central nervous system of the person with stroke is the electroencephalogram EEG as it provides a continuous real-time non-invasive measurement of brain function that provides new insights into the pathophysiology of the brain EEG analysis of brain disorders can be carried out with different methods such as network analysis and connectivity examination machine learning graph neural networks and examination of band frequency changes

Among the EEG analysis methods that have not yet been tested in the stroke population following DTT intervention is the Fast Fourier Transform FFT a powerful tool for analysing the frequency of signals When applied to a signal the FFT function converts the signal from a time domain to a frequency domain The main objective of this study is to analyse how in the different EEG bands delta theta alpha and beta of stroke patients are modified after converting the brain signal into Fourier seriestransforms before and after a DTT intervention

The intervention will consist of three different tasks that participants have to carry out while performing mental calculations counting backwards from 100 by ones twos and threes The three tasks will be as follows grouping blocks of different colours into groups according to colour picking up beans with a spoon and carrying them to a specific place opening and closing a bottle cap with the affected hand The total duration of the intervention will be 12 sessions divided into three days per week for four weeks

The main outcome is EEG data which will be collected both before and after intervention under the supervision of a neurologist with the participant in a resting state and eyes closed EEG recording is carried out during 3 minutes with 10-20 system 19 electrodes Fp1 Fp2 F7 F3 Fz F4 F8 T7 C3 Cz C4 T8 T10 P3 Pz P4 P8 T9 P7 and a sampling rate of 256 Hz The Fast Fourier Transform FFT which has proven to have less order complexity will be used for the data analysis

In addition other variables on upper limb function elbow flexor muscle tone wrist extension range of motion and handling in activities of daily living will be collected

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None