Reliability and Validity of the Kinesthetic and Visual Imagery Questionnaire in Acute Stroke Patients

December 30, 2019 updated by: Ece Candur, Hacettepe University

Investigation of Reliability and Validity of the Kinesthetic and Visual Imagery Questionnaire in Acute Stroke Patients

This study was planned to investigate the validity and reliability of the Kinesthetic and Visual Imagery Questionnaire in patients with acute stroke.

The objectives of the research are:

  1. To evaluate the validity of the Kinesthetic and Visual Imaginery Questionnaire in acute stroke patients aged 50-75 years
  2. To evaluate the test-retest reliability of the Kinesthetic and Visual Imaginery Questionnaire in acute stroke patients aged 50-75 years

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Motor imagery (MI) is the mental representation of movement without any real body movement. MI is a complex and cognitive process involving the use of sensory and perceptual memories related to motor movements.Various studies using brain imaging techniques have found that during motor imagery, brain areas similar to voluntary movement are activated or the motor cortex can be stimulated. These findings suggest that stroke patients who cannot physically move their limbs can stimulate brain regions responsible for motor movements using motor imagery. The Kinesthetic and Visual Imaginery Questionnaire (KVIQ) is a motor imagery questionnaire developed for people who need to be guided for different reasons and cannot perform complex movements. Evaluate both visual and kinesthetic dimensions of motor images. This study was planned because of the need for evaluation of motor imagery for stroke patients, who mostly have motor and sensory problems.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Altındağ
      • Ankara, Altındağ, Turkey, 06080
        • Recruiting
        • Hacettepe University
        • Contact:
        • Principal Investigator:
          • Ece Candur, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute stroke patients in the Stroke Unit of Hacettepe University, Department of Neurology will be included in the study.

Description

Inclusion Criteria:

  • First stroke and ischemic stroke
  • Being in the 50-75 age range
  • At least 24 hours after stroke
  • Absence of apraxia and aphasia
  • Get at least 15 points on the Glasgow Coma Scale
  • Score of 24 or more from Mini Mental Test
  • Stable vital signs and no improvement in symptoms for 48 hours
  • No signs of depression (score 15 or less from the Beck Depression Scale)
  • Sitting without support for 1 minute
  • Not participating in another concurrent study
  • Agree to participate in the study

Exclusion Criteria:

  • Other known neurological diseases
  • Neglect of the body half
  • Presence of cerebellum or mesencephalon lesion
  • Drug use affecting cognition
  • Patients with epilepsy, seizure attacks
  • Those with severe heart and lung disease that may interfere with the study
  • Patients with visual or auditory disabilities that might interfere with the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Acute stroke patients
Behavioral: Determine what the imagery levels are
Determine the motor imagery: kinesthetic and visual imagery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Kinesthetic and Visual Imagery Questionnaire
Time Frame: 15 minutes
The Kinesthetic and Visual Imagery Questionnaire is a representative tool to assess motor imagery ability. The questionnaire can be used to assess healthy individuals, as well as those with physical disabilities. It allows easy evaluation of motor imagery ability in a sitting position with single joint motions. Furthermore, the questionnaire assesses both visual and kinesthetic dimensions of motor imagery. The questionnaire is not self-administered, rather it is administered by a trained assessor. It assesses the vividness of each dimension of motor imagery (clarity of the image/intensity of sensation) on a 5-point ordinal scale.The long version comprises 20 items (10 movements for each scale) and the short version includes 10 items (5 movements for each scale). Higher scores mean a better outcome.
15 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Barthel Index
Time Frame: 5 minutes
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL.
5 minutes
Motor Assessment Scale
Time Frame: 15 minutes
The Motor Assessment Scale is a clinical assessment tool that evaluates eight areas of motor function in recovering stroke patients. The scale uses tasks related to activities of daily living to measure the full range of functional motor performance in stroke survivors. These include: Supine to side-lying, supine to sitting over side of bed, balanced sitting, sitting to standing, walking, upper arm function, hand movements, hand activities. Items are assessed using a 7-point scale (0-6). A score of 6 indicates optimal motor behavior item scores (with the exceptions of the general tonus item) are summed to provide an overall score (out of 48 points).Higher scores mean a better outcome.
15 minutes
Trail Making Test
Time Frame: 5 minutes
The Trial Making Test (TMT) can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The TMT consists of two parts, A and B. Part A&B consists of one sample test and one task. The numbers are randomly printed on the sample worksheet. The subject is required to join consecutive numbers in order by drawing connecting lines. The worksheet consists of numbers 1 to 25. The time taken to join consecutive numbers is taken as the subject's score. Part B consists of a sample test as well as the main task. The numbers 1 to 13 and letters A to L are presented on the task worksheet. The participant is required to alternate between numbers and letters as s/he proceeds in an ascending sequence.
5 minutes
Trunk İmpairment Scale
Time Frame: 2 minutes
The Trunk İmpairment Scale, developed by Fujiwara et al. In 2004, is another scale that evaluates post-stroke trunk impairment. The 7-parameter scale included vertical posture perception, trunk rotation muscle strength and reflexes on the affected and unaffected side, and trunk vertically and abdominal manual muscle test sub-parameters in the stroke impairment assessment set of Tsuji et al. [33]. Each parameter is evaluated over 4 points. The total score ranges from a minimum of 0 to a maximum of 21 points. Higher score means better performance.
2 minutes
Mental Chronometry
Time Frame: 1 minute
Mental chronometry is an objective method used in the evaluation of motor imagery. It examines the time difference between actually making a movement and imagining the same movement.The modified box block test will be used to measure mental chronometry.The modified version has 15 cubes, and the individual's time to transfer all of these cubes is recorded. The individual is then asked to imagery this transfer. The imagery time is also recorded and the time difference are calculated.
1 minute
Mental Chronometry Ratio
Time Frame: 1 minute
Real performance time - imagery time/ real performance time
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO 19/804

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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