NCT06286436

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

February 22, 2024

Last Update Submit

May 13, 2024

Conditions

Keywords

Electroencephalographyrehabilitationphysiotherapystroke

Outcome Measures

Primary Outcomes (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.

    Before and after intervention (4 weeks)

Secondary Outcomes (4)

  • Upper limb function

    Before and after intervention (4 weeks)

  • Elbow flexor muscle tone

    Before and after intervention (4 weeks)

  • Wrist extension range of motion

    Before and after intervention (4 weeks)

  • ADLs

    Before and after intervention (4 weeks)

Study Arms (1)

Dual-task training

EXPERIMENTAL
Other: Dual-task training

Interventions

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.

Dual-task training

Eligibility Criteria

Age35 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Beheshti University of Medical Sciences

Tehran, Velenjak, Iran

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of iHealthy Research Group

Study Record Dates

First Submitted

February 22, 2024

First Posted

February 29, 2024

Study Start

February 15, 2024

Primary Completion

April 29, 2024

Study Completion

April 29, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Data will be shared on a reasonable request contacting with the main author once data has been published

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Once research has been published

Locations