NCT06946082

Brief Summary

A large number of people have a stroke each year and it is a major cause of disability worldwide. Upper limb motor impairments, aphasia, body control problems and decreased motor imagery ability are common after stroke. Although there are studies showing that these impairments may be related to each other, there is no comprehensive study examining the relationship between Turkish language skills and these motor functions. The aim of this study was to evaluate the relationship between Turkish language skills and upper extremity motor function, trunk control and motor imagery ability in stroke patients.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 10, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

April 15, 2025

Last Update Submit

April 19, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Aphasia Language Assessment Test (ADD)

    The Aphasia Language Assessment Test was developed by Maviş and Toğram. It is a language test that allows diagnosing aphasia, determining the type of aphasia, determining the performance of the individual with aphasia in all language areas and selecting appropriate therapy goals for the individual. The Aphasia Language Assessment Test consists of 8 subtests assessing speech fluency, auditory comprehension, repetition, naming, reading, speech acts, grammar and writing. Correct and independent responses are scored as 2; incomplete, inadequate or assisted responses as 1 and incorrect responses or no response as 0.

    Baseline (upon enrollment)

  • GAT-2 (Gulhane Aphasia Test)

    This test consists of six parts and assesses the individual's awareness, comprehension (speech comprehension, reading comprehension), oral-motor skills, automatic speech, repetition and naming skills. This test also determines whether the individual diagnosed with aphasia is accompanied by dysarthria, apraxia or paraphasia in language production. Hearing comprehension is evaluated with 20 items, reading comprehension with 15 items, repetition with 6 items and naming with 13 items. The score of each section is expressed as a percentage. The total aphasia score is obtained by summing the scores of all sections (minimum 0, maximum 600 points). A lower aphasia score indicates more severe aphasia. A score of 40% or less on at least three sections indicates moderate-to-severe aphasia. However, the GAT only gives a numerical value for aphasia, and aphasia cannot be typed.

    Baseline (upon enrollment)

Secondary Outcomes (9)

  • Fugl Meyer Upper Extremity Assessment Scale (FMA-UE)

    Baseline

  • Upper Extremity Activity Test

    Baseline

  • Body Disorder Scale

    Baseline

  • Functional Independence Scale (FIM)

    Baseline

  • Movement Imagery Survey-3 (MIS)

    Baseline

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted with individuals who have had a stroke and are 18 years of age or older. Participants will be individuals who have had a stroke at least 1 week ago, who have not received motor imagery practice before, whose native language is Turkish, and whose cognitive competence has been confirmed by the Standardized Mini Mental Test (SMMT) (≥24 points). In addition, only individuals with a history of cerebrovascular events will be included.

You may qualify if:

  • years of age or older
  • Stroke onset more than 1 week
  • Not having practiced imagery before
  • Being a native speaker of Turkish
  • Standardized Mini Mental Test (SMMT) Score of 24 and above
  • History of cerebrovascular events
  • Not having any neurological disorder other than stroke
  • The ability to grasp and hold a 2.5 cm cube

You may not qualify if:

  • No consent from the family or person
  • Having had a stroke before
  • Severe hearing or vision loss
  • Individuals are excluded if they have other primary medical conditions that may affect language and motor functions (e.g. brain tumor, Parkinson's disease, severe post-stroke depression, Alzheimer's disease) or have undergone surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Bakırçay University

Izmir, 35665, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

HemiplegiaAphasiaStroke

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Emine Timur, Bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher/Student

Study Record Dates

First Submitted

April 15, 2025

First Posted

April 27, 2025

Study Start

December 10, 2024

Primary Completion

September 10, 2025

Study Completion

December 10, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

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