NCT06630403

Brief Summary

The aim of this study was to evaluate motor imagery ability, reaction time and cognitive function parameters in children with CF and non-CF bronchiectasis compared to healthy peers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

September 17, 2024

Last Update Submit

October 5, 2024

Conditions

Keywords

bronchiectasiscognitive functionmotor imagery

Outcome Measures

Primary Outcomes (6)

  • Trail Making Test

    The Trail Making Test is divided into two parts. In the first part, the participant is asked to connect the 23 numbers in the circle randomly placed on the page with a pencil in an orderly order, and in the second part, the participant is asked to draw and connect the 23 numbers and letters in the circle in a mixed order. In the second part, the individual has to change sets between one letter and one number. (1- A, 2-B, 3-C, 4-D, etc.).The test can be applied between the ages of 8-79.

    The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  • Stroop Test

    The Stroop Test consists of four parts. The first part contains words written in black (e.g blue), the second part contains colors and the last part contains words written in different colors (e.g. the word blue written in red ink). The participant is expected to fulfill these tasks in turn. The participant has to correctly read the words in the first part, say the colors in the next part, read the colored word in the third part, and then say the color in which the word is written in the last part.

    The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  • Nelson Hand Reaction Test

    The tester holds the ruler by the tip and between the thumb and index fingers of the subject and releases the ruler. When the ruler is released, the participant is asked to catch the ruler. The participants hand is fixed and 20 trials are performed in the test. At the top point where the subject grabs the ruler with his/her fingers, the reaction time of the subject is determined. The highest and lowest five trials are discarded and the remaining ones are averaged.

    The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  • Nelson Foot Reaction Test

    The participant removes his/her shoes and sits with the toe 2.5 cm from the wall and the heel 5 cm. The tester holds the reaction time ruler at the edge of the wall and between the wall and the subjects foot, with the baseline at the tip of the thumb. The subject is instructed to look at the concentration line and to hold the ruler, which falls after the ready command, by pinching it against the wall with the toe of the foot. This test is repeated 20 times.

    The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  • Movement Imagery Questionnaire-3

    It consists of 3 subscales evaluating external visual imagery, internal visual imagery and kinesthetic imagery and a total of 12 items. Before scoring each movement, the participant is asked to perform the movement and then the movement is imaged three times. Scoring is done between 1 and 7, with "1 point: very difficult to see/feel, 7 points: very easy to see/feel". A maximum score of 84 can be obtained on the MIQ-3 questionnaire. A higher score on the test means that the person has a better ability to visualize.

    The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes

  • Vividness of Motion Imagery Questionnaire

    In the Vividness of Movement Imagery questionnaire, the person does not need to perform the movements before visualizing them. This scale consists of four scenarios and you are asked to rank on a scale of one to five how vividly you picture them in the participant mind. Each scenario asks you to imagine the face of a loved one, a view of your favorite grocery store or a beautiful landscape and rate the vividness of the details in each scene. The individual is asked to imagine 4 scenarios first with eyes open and then with eyes closed. As a result of this situation, the individual can reach a maximum of 160 in total score.

    The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes

Secondary Outcomes (6)

  • Dalhousie Dyspnea and Perceived Exertion Scale

    The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  • 6 Minute Walk Test

    The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  • Quality of Life Scale for Children

    The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  • Tampa Kinesiophobia Scale

    The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  • Respiratory Function Test

    The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  • +1 more secondary outcomes

Study Arms (2)

Children with Bronchiectasis Experiment Group

Children with bronchiectasis Participants will be required to sign an informed consent form before the evaluation. Assesment Methods: 1. Demographic data will be collected verbally. 2. The number of exacerbations in the last 1 year, hospitalization and medications used will be questioned. 3. Pulmonary Function Test will be applied. 4. Reaction time will be evaluated with the Nelson Hand-Foot Reaction Test. 5. Functional capacity of the patient will be evaluated with the 6 Minute Walk Test. 6. Dalhousie Dyspnea and Perceived Exertion Scale will be used to determine the level of dyspnea. 7. Quality of life will be assessed with the "Quality of Life Scale for Children". 8. Fear of movement will be assessed with the Tampa Kinesiophobia Scale. 9. Motor Imagery ability will be assessed with the Movement Imagery Questionnaire-3, Vividness of Movement Imagery. 10. Cognitive functions will be assessed with Trail Making Test and Stroop Test.

Other: Demographic DataOther: Disease HistoryOther: Pulmonary Function TestOther: Reaction TimeOther: Functional CapacityOther: Dyspnea PerceptionOther: Quality of LifeOther: Fear of movementOther: Ability of Motor ImageryOther: Cognitive Functions

Healthy Controls

Healthy Peers Participants will be required to sign an informed consent form before the evaluation. Assessment Methods: 1. Demographic data (age, height, weight, BMI) will be collected verbally via the assessment form. 2. Pulmonary Function Test will be applied. 3. Reaction time will be evaluated with the Nelson Hand-Foot Reaction Test. 4. Functional capacity of the patient will be evaluated with the 6 Minute Walk Test. 5. Dalhousie Dyspnea and Perceived Exertion Scale will be used to determine the level of dyspnea. 6. Quality of life will be assessed with the "Quality of Life Scale for Children". 7. Fear of movement will be assessed with the Tampa Kinesiophobia Scale. 8. Motor Imagery ability will be assessed with the Movement Imagery Questionnaire-3, Vividness of Movement Imagery. 9. Cognitive functions will be assessed with Trail Making Test and Stroop Test.

Other: Demographic DataOther: Pulmonary Function TestOther: Reaction TimeOther: Functional CapacityOther: Dyspnea PerceptionOther: Quality of LifeOther: Fear of movementOther: Ability of Motor ImageryOther: Cognitive Functions

Interventions

Demographic data (age, height, weight, BMI) will be collected verbally through an assessment form.

Children with Bronchiectasis Experiment GroupHealthy Controls

The number of exacerbations in the last 1 year, hospitalization and medications used will be questioned.

Children with Bronchiectasis Experiment Group

Pulmonary Function Test will be performed with a spirometer.

Children with Bronchiectasis Experiment GroupHealthy Controls

Reaction time will be evaluated with the Nelson Hand-Foot Reaction Test.

Children with Bronchiectasis Experiment GroupHealthy Controls

Functional capacity will be evaluated with 6 minute walk test

Children with Bronchiectasis Experiment GroupHealthy Controls

Dalhousie Dyspnea and Perceived Exertion Scale will be used to determine the level of dyspnea

Children with Bronchiectasis Experiment GroupHealthy Controls

Quality of life will be assessed with the "Quality of Life Scale for Children\"

Children with Bronchiectasis Experiment GroupHealthy Controls

Fear of movement will be evaluated with Tampa Kinesiophobia Scale

Children with Bronchiectasis Experiment GroupHealthy Controls

Motor Imagery ability will be assessed by Movement Imagery Questionnaire-3 and Vividness of Movement Imagery

Children with Bronchiectasis Experiment GroupHealthy Controls

Cognitive functions will be assessed with Trail Making Test and Stroop Test

Children with Bronchiectasis Experiment GroupHealthy Controls

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Twenty patients with bronchiectasis and 20 healthy individuals who met the inclusion criteria applied to the study. The study consisted of 2 groups, experimental and control.

You may qualify if:

  • Diagnosed with cystic or non-cystic bronchiectasis
  • Being clinically stable
  • Not having an exacerbation or infection
  • Being between the ages of 7-18
  • To be able to read and understand Turkish

You may not qualify if:

  • Unstable concomitant cardiac, orthopedic or neurologic disease
  • History of previous lung or liver transplantation
  • History of acute exacerbation and/or hospitalization in the last 1 month
  • Changes in medical treatment during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bronchiectasis

Interventions

DemographyRespiratory Physiological PhenomenaReaction TimeFunctional Residual CapacityQuality of Life

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Population CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthCirculatory and Respiratory Physiological PhenomenaPsychological TechniquesInvestigative TechniquesBehavioral Disciplines and ActivitiesNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTotal Lung CapacityLung Volume MeasurementsRespiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisHealth Status

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

September 17, 2024

First Posted

October 8, 2024

Study Start

September 5, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10

Locations