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StrokeNCT06286436

Effect of Dual-task Training on the Number of EEG Band in Stroke Patients

A study testing Dual-task training in people with Stroke and Electroencephalography, run by Universidad de Zaragoza at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 75 years, women only
Conditions the study is for
Stroke, Electroencephalography
What is being tested?
Dual-task training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteIran
Study dates
15 Feb 2024to 29 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Unilateral stroke proven by imaging evidence
  • Women between 35 and 75 years old
  • At least six months have passed since the onset of the stroke

Who cannot join

  • Suffering from another neurological or orthopedic disease
  • Score greater than 3 on the modified modified Ashworth scale in the upper limb
  • Having received a botulinum toxin injection before or during the course of the study
  • History of brain surgery
  • Be using medication that may alter cortical activity or brain plasticity or aimed at reducing the level of spasticity.

Trial locations and contacts

1 site in 1 country.

Iran1 site
  • Shahid Beheshti University of Medical Sciences

    Tehran, Velenjak

Other trials in Iran

About this study

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 EEG's role in evaluating DTT effects on stroke patients, particularly using FFT to analyze brain signal frequencies.

Read the 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 person's 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 series/transforms 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.

Being tested
Dual-task training
Keywords
Electroencephalography, rehabilitation, physiotherapy, stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual-task trainingOther

    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.

Study groups in NCT06286436
Study groupRoleWhat they receive
Dual-task trainingExperimentalNot described
Receives: Other: Dual-task training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EEG Data

    EEG data 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 will be 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. Frequencies below 1Hz and above 40Hz will be filtered. One of the three minutes of EEG collection will be randomly selected, and analysis will be carried out for that minute only. Before data analysis, abnormal waves such as blinking and electromyographic signals will be removed. All these operations will be carried out in MATLAB and by EEGLab toolbox.

    Measured: Before and after intervention (4 weeks)

Secondary outcomes (4)
  1. Upper limb function

    Upper limb function will be measure with the "Box and Block test", which is a functional test to specifically measure unilateral manual dexterity including grasping, carrying and releasing objects, consisting of transferring 150 coloured wooden cubes, each measuring 1 inch, from one box to another as quickly as possible within 60 seconds using only the affected hand.

    Measured: Before and after intervention (4 weeks)

  2. Elbow flexor muscle tone

    Elbow flexor muscle tone will be measured with the modified modified Ashworth scale, scored on an ordinal scale from 0 to 4: 0 = no increase in muscle tone; 1 = slight increase in muscle tone, manifested by a catch and release or minimal resistance at the end of the range of motion when affected part is moved in flexion or extension; 2 = a marked increase in muscle tone, manifested by a catch in the middle range and resistance throughout the remainder of the range of motion, but the affected part easily moved; 3 = considerable increase in muscle tone, passive movement difficult; and 4 = affected part rigid in flexion or extension

    Measured: Before and after intervention (4 weeks)

  3. Wrist extension range of motion

    Wrist extension range of motion will be measured with a goniometer

    Measured: Before and after intervention (4 weeks)

  4. ADLs

    The functional assesment of the patient in ADLs will be measured with the Barthel Index, which is a scale that scores ten basic aspects of activity related to self-care and mobility (bowels, bladder, grooming, toilet use, feeding, transfer, mobility, dressing, stairs and bathing) from 0 to 100 where lower scores indicate greater dependency

    Measured: Before and after intervention (4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start15 Feb 2024
  3. Primary completion29 Apr 2024
  4. Study completion29 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06286436
Sponsor's protocol ID
IR.SBMU.RETECH.REC.1401.842
Status last verified
May 2024
First submitted
22 Feb 2024
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared on a reasonable request contacting with the main author once data has been published

Questions about this trial

What is this clinical trial studying?

A study testing Dual-task training in people with Stroke and Electroencephalography, run by Universidad de Zaragoza at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EEG Data (time frame: Before and after intervention (4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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