Skip to main content
Clinical Trials/NCT04973956
NCT04973956CompletedNot Applicable

Influencia de la Ansiedad en el Aprendizaje Motor de Una Tarea Manual Precisa y en la Capacidad de Imaginación Motora

Susana Nunez Nagy8 sites in 2 countries60 target enrollmentStarted: September 14, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
8
Primary Endpoint
Task accuracy

Study Overview

Brief Summary

In motor learning, to consider that movements are produced by the cooperation and combination of many brain structures and are influenced by the emotions to which individuals are subjected is essential. Several neural circuits have been identified that closely link the emotional system and the motion control system.

Anxiety is defined by persistent and excessive worries that do not disappear even in the absence of the stressor. Anxiety has been found to produce inefficiencies in information processing, which can result in performance deficits, as well as self-reported anxiety has been linked to poorer working retrieval performance. In these stress and anxiety contexts, relaxation techniques have been widely used to reduce psychophysiological arousal levels.

Understanding how movement, emotions and interactions are regulated is significant because of the large number of movements humans perform. Of these, manual tasks represent precise movements that require the integration of many elements by the nervous system to perform these tasks successfully. How anxiety influence the way manual tasks are learned is still unknown.

On the other hand, motor imagery (MI) is a cognitive process that is an important contributor to how movements are planned and executed. The use of MI has been recommended to improve movement learning and task execution. Knowing MI capacity is essential for creating effective and individualized MI programs. However, how a relax intervention can affect the motor imagery ability in anxiety people is still unknown.

The aim of our study was to find out whether a relaxation intervention prior to MI practice in subjects with anxiety can influence the learning of a precise manual task not previously trained on four parameters of fine motor control: time, error, speed, and accuracy. On the other hand, the aim is to determine if the ability of internal visual, external visual, and kinaesthetic imagery varies when the anxiety participants are subjected to relaxation.

The investigators expect that participants with anxiety, to whom relaxation is induced, will show better motor performance on the fine motor task and better motor imagery ability. In contrast, the investigators expect that participants with anxiety, to whom relaxation is not induced, will show poorer motor performance on the fine motor task and poorer motor imagery ability.

Detailed Description

In order to meet the study objectives of determining and quantifying the effects of relax in anxiety people on learning a precise manual task and on motor imagery ability, this study will be conducted. The development of the study will take place in a conditioned room belonging to the University of Alcalá, the Complutense University of Madrid, the European University of Madrid, or Claude Bernard University Lyon 1. The study may also be carried out in other Spanish and international university centers, subject to the consent and permission of the respective centres. The study will be carried out by all national and international laws, regulations, and recommendations.

The study design will be longitudinal, experimental, randomized, and double-blind, as specified in the present registry.

The study population will be composed of participants who are undergraduate and postgraduate students at the university centers where the study will be carried out, from which the participants will be recruited. All participants included in the study must meet the study selection criteria and participate voluntarily after reading the information sheet and signing the informed consent form.

The study will consist of two intervention groups, both groups will have anxiety measured with the State-Trait Anxiety Inventory (STAI) and then be randomized to either the relaxation intervention group or the control group. Each group will consist of a minimum number of 20 subjects to be able to study the desired effect.

After each participant freely chooses to participate in the study, an initial questionnaire will be administered to ensure that the participants meet the criteria for inclusion in the study. At this point, the participants will be coded by assigning them a number, which will serve to identify each participant throughout the study. Participants will take the STAI, one of the most widely used instruments for the self-reported assessment of anxiety. Participants with scores indicative of anxiety will be included in the study. Included participants will be randomized through sealed envelopes stratified by gender to one of two experimental groups: relaxation or control. They will also take the Edinburgh Handedness Inventory (EHI) to determine the participant's laterality, and the Movement Imagery Questionnaire-3 (MIQ-3) to measure internal visual, external visual, kinaesthetic imagery capacity. At the same time of MIQ-3, the experimenter will record the execution and imagery times were recorded (for subsequent calculation of the time discrepancy between executed and imagery as a measure of temporal congruence between them).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Masking Description

The participant does not know what the other participants are doing, the researcher knows which study and group the subject is in, but only sets up the computerized presentations for each group and assigns folders within the computer that collects the data, thus avoiding a possible information bias, and finally, another researcher blind to the intervention will analyse the data to obtain the results.

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Men and women between 18 and 35 years of age.
  • Normal or corrected vision specifying the method of correction.
  • Normal or corrected hearing specifying method of correction.
  • Unfamiliar with the assessment and uses of motor imagery.
  • Presence of State-Trait Anxiety Inventory scores corresponding to anxiety.

Exclusion Criteria

  • Subjects who have suffered fractures, dislocations, or traumatic processes in any segment of the non-dominant upper limb or fingers, wrist, or elbow of the dominant upper limb in the last 6 months.
  • Subjects with learning disabilities or problems in reading or writing.
  • Subjects with a history of any neurological disease, cardiovascular disease, myopathic disease, epileptic seizure, absence seizure, sleep apnoea, chronic fatigue syndrome, or fibromyalgia.
  • Taking any medication to suppress anxiety, to sleep, antidepressants, antihistamines, muscle relaxants, psychotropic, or other medications that interfere with the nervous system.
  • Intake of nervous system depressants or stimulants such as caffeine or theine in the last 8 hours.
  • Presence of localised skin lesion or disease in the wrist area.

Outcomes

Primary Outcomes

Task accuracy

Time Frame: During manual task performance in acquisition, short-term retrieval, and long-term retrieval

It shall be the ability of the subject to learn at any rate. It shall be expressed in pixels per second. It shall be recorded and measured by MATLAB.

Timing error

Time Frame: During manual task performance in acquisition, short-term retrieval, and long-term retrieval

It is the absolute value of the difference between the duration of 2 seconds requested from the subjects and the total time elapsed in the execution of the trajectory. It shall be expressed in seconds (s). It shall be recorded and measured using MATLAB.

Timing accuracy

Time Frame: During manual task performance in acquisition, short-term retrieval, and long-term retrieval

The ability of the subject to learn the task at the requested rate of 2 seconds per lap. It shall be expressed in square pixels per second. It shall be recorded and measured by MATLAB.

Motor Imagery Capacity

Time Frame: Before induction of acute stress and in the resting period between short-term and long-term retrieval after induction of acute stress

This will be measured using the Movement Imagery Questionnaire-3, differentiating between the kinaesthetic, external visual and internal visual imagination subscales, each scored on a Likert scale from 1 to 7.

Trayectory error

Time Frame: During manual task performance in acquisition, short-term retrieval, and long-term retrieval

It shall be the sum of the error between each of the points defining the path of the circumference. Pixels squared shall be considered as the unit of length measurement. To be recorded and measured with MATLAB. To be recorded and measured with MATLAB.

Discrepancy time

Time Frame: Before induction of acute stress and in the resting period between short-term and long-term retrieval after induction of acute stress

It will be the difference between the execution times and imagery of the MIQ-3 items. It will be measured with a stopwatch by the experimenter.

Secondary Outcomes

  • Electrodermal Activity(During the procedure)
  • Heart Rate Variability(During the procedure)

Investigators

Sponsor
Susana Nunez Nagy
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Susana Nunez Nagy

PhD. Associate Professor of Physiotherapy

University of Alcala

Study Sites (8)

Loading locations...

Similar Trials