NCT06482528

Brief Summary

Motor Imagery (MI) is defined as imagining an action in the mind without any explicit physical movement. MI is considered an "offline" process of the motor areas of the brain. Neuroimaging studies have shown that roughly the same neural structures play a role both during movement execution and MI. Specifically, these neural structures; supplementary motor area (SMA), premotor cortex (PMC), and in a growing number of studies, primary motor cortex (M1), inferior parietal lobe (IPL), basal ganglia, and cerebellum. In MI, the changes occurring in the Central Nervous System (CNS), such as the activation of the structures responsible for planning the movement and the purpose for which the movement will be performed, are similar to physical movement, but with the inhibition of the last motor neuron (primary motor area) responsible for revealing the movement, the movement is not physically performed and the motor visualization occurs. During motor imagery, monitoring the quality of the individual's imagery session is very important for the effectiveness of the session. Additionally, studies have shown that giving the subject biofeedback regarding mental work can modulate the individual's mental work. For these purposes, the quality of an individual's motor imagery during a motor imagery session can be measured by biological measurement methods such as fMRI and autonomic nervous system response. In studies conducted on the autonomic nervous system response, changes in skin resistance and heart rate variations were observed. However, these methods are very costly and cannot be accessed in every clinic. In the literature, the Polar HRV device for measuring heart rate variability is a measuring device with proven validity and reliability and is easily accessible in terms of cost. However, we do not yet know whether Polar HRV is a valid and reliable measurement tool to measure the quality of an individual's imagery session during a motor imagery session. This study aims to determine the effects of the individual's autonomic nervous system during the kinesthetic motor imagery session. To measure the responses and to investigate whether the polar HRV device is a valid and reliable tool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

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

April 29, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2024

Completed
Last Updated

March 5, 2025

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

June 26, 2024

Last Update Submit

March 4, 2025

Conditions

Keywords

Imageryautonomic nervous system

Outcome Measures

Primary Outcomes (2)

  • Electrodermal Activity

    Electrodermal activity recording will be carried out in the Research Laboratory of Kütahya Health Sciences University Faculty of Medicine, Department of Physiology, at normal room temperature (20±2⁰C) in a dimly lit room isolated against external factors. EDA recordings will be taken bilaterally with the MP36 system. EDA recordings were made using two instruments placed on the distal phalanx surface of the 2nd and 3rd fingers of both hands, two on the right hand and two on the left. It will be done with four Ag/AgCl electrodes in hand. These four electrodes will be connected to the MP 36 system.

    10 minutes

  • Polar HRV (Heart Rate Variability)

    The Polar H10 heart rate sensor will be used to evaluate heart rate and heart rate variability. Polar H10 is a heart rate sensor placed under the chest with an elastic electrode strap. RR intervals will be recorded for 5 minutes with the smartphone application. Measurements will be taken with the participant in a sitting position, without any clothing in the area where the device will be placed.

    10 minutes

Secondary Outcomes (3)

  • Mental Chronometer

    5 minutes

  • Mental Rotation

    100 second

  • Kinesthetic and Visual Imagery Questionnaire

    15 minutes

Study Arms (1)

Motor imagery group

EXPERIMENTAL

Individuals who meet the inclusion criteria will fill out the demographic data form after signing the informed consent form. Then, individuals' motor imagery abilities will be evaluated using HIA-3, mental rotation and mental stopwatch. After the evaluation, the individuals will be taken to a quiet and isolated room and the Polar H10 device will be placed on the chest area of the individuals to measure heart rate variations and (MP36 system and BİOPAC software) will be placed to measure the electrodermal activities of the individuals. Then, a motor imagery session will be held for individuals with a physiotherapist who is an expert in the field.

Other: Motor Imagery

Interventions

After the measurement devices are connected to the individuals, they will be seated in a comfortable chair. After the calibration of the devices, individuals will undergo a 2-minute relaxation session. During the relaxation session, individuals will be asked to focus on their breathing and relax as much as possible. Then, heart rate variability, electrodermal activities and respiratory frequencies of the individuals will be measured in a sitting position for 5 minutes. In case of rest, after taking the variables, individuals will be kept to rest for 10 minutes. After 10 minutes, the devices will be placed on the individuals again and a 2-minute relaxation session will be held. Then, individuals will be asked to imagine running through kinesthetic imagery for 5 minutes. Feedback will be given to individuals throughout the entire session. These feedbacks will be given verbally with an audio recording prepared by the physiotherapist.

Also known as: Relaxation
Motor imagery group

Eligibility Criteria

Age18 Years - 30 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being 18-30 years old
  • Volunteering to participate in the study
  • Being seemingly healthy
  • Not having any neurological or orthopedic disease
  • Not having any vision, hearing, or speech problems that would prevent the tests from being performed.

You may not qualify if:

  • Pregnancy and a history of any previous disorder or surgery that alters physical performance or physiological functions
  • Have previous experience with Motor Imagery techniques or training
  • People being treated with any medication that affects the central nervous system will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

Location

Study Officials

  • Meltem Işıntaş

    Kutahya Health Sciences University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 1, 2024

Study Start

April 29, 2024

Primary Completion

August 8, 2024

Study Completion

December 27, 2024

Last Updated

March 5, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations