NCT06106542

Brief Summary

In addition to its many effects, physical movement is known to change both systemic blood circulation and muscle blood flow. In a study examining the effects of motor imagery, which produces effects similar to physical movement, on muscle oxygenation, no change in muscle oxygenation was detected with motor imagery. However, no study has been found examining muscle oxygenation along with motor imagery in stroke patients. However, it has not been investigated whether there is a difference in muscle oxygenation between the affected and less affected extremities after stroke. For this reason, our study was planned to examine the effect of motor imagery on lower extremity muscle oxygenation in stroke patients. In addition, in our study, we will examine whether there is a difference in muscle oxygenation between the affected and less affected extremities in stroke patients under different conditions (rest / physical movement / motor imagery (mental movement)). Since there are insufficient studies in this field in the literature, we think that our study will lead to future studies.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Status
unknown

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

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

November 2, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2025

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 24, 2023

Last Update Submit

October 24, 2023

Conditions

Keywords

motor imageryMuscle oxygenation

Outcome Measures

Primary Outcomes (6)

  • muscle oxygenation

    Muscle oxygenation measurement with Moxy muscle oxygen monitor via quadriceps femoris muscle in both affected and less affected extremities

    baseline

  • Kinesthetic and Visual Imagery Questionnaire

    It is a tool used to evaluate the imagination levels of healthy and physically disabled individuals. There are a total of 20 items in the survey, 10 visual and 10 kinesthetic. With the questionnaire, the intensity level of imagery is recorded on a 5-point Likert scale. A high score is considered an indication of a good level of visualization.

    baseline

  • Movement imagery questionnaire 3

    The survey consists of 12 items. With the questionnaire, the intensity level of imagery is recorded on a 7-point Likert scale. A high score is considered an indication of a good level of visualization.

    baseline

  • Mental Stopwatch/ Mental Chronometer

    Mental stopwatch is a method that allows objective measurement of motor imagery by examining the time difference between the physical execution of the movement (Movement Execution Time, MET) and the mental visualization of the same movement (Movement Imagery Time, MIT). A stopwatch will be kept at the beginning of the visualization and the stopwatch will be stopped when the individual says that he/she has finished visualizing the test. The physically realized time will be compared with the imagined time. It will be used with the Timed Up and Go Test.

    baseline

  • Timed Up and Go Test

    This test evaluates the dynamic balance of individuals during functional mobility; It includes components such as standing, walking and turning. Individuals are asked to stand up from the chair they are sitting on without support, and after walking a distance of 3 meters, they are asked to return from the designated area and sit on the chair again without support. At the end of the test, the time calculated with a stopwatch is noted in seconds.

    baseline

  • Five Times Sit to Stand Test

    The individual was asked to stand up and sit down five times without holding on to the chair, and the time taken was recorded. This method, which is valid and reliable in stroke patients, has been shown to be related to lower extremity muscle strength and balance. Low times are indicative of high performance.

    baseline

Study Arms (1)

stroke group

assessment of effect motor imagery on muscle oxygenation

Other: assessment

Interventions

assessment of motor imagery on muscle oxygenation

stroke group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals between the ages of 40-75 who are diagnosed with stroke and meet the inclusion criteria who volunteer to participate in the research constitute the sample of the study.

You may qualify if:

  • Being between the ages of 40-75
  • Being diagnosed with stroke
  • BMI \<30kg/cm2
  • Subcutaneous fat thickness \<12mm
  • Mini Mental State Test Score being 24 or above

You may not qualify if:

  • Having another musculoskeletal, cardiovascular, pulmonary, metabolic or neurological disease that is serious enough to prevent participation in the study
  • Having serious vision and hearing problems
  • Presence of serious cognitive impairment determined by the physician that would prevent the tests from being performed
  • Presence of an open wound or infection in the area to be measured

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

November 2, 2023

Primary Completion

November 2, 2024

Study Completion

November 2, 2025

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share