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临床试验/NCT04911439
NCT04911439已完成不适用

Influencia de Los Niveles de Alerta en el Aprendizaje Motor de Una Tarea Manual Precisa, en la Memoria a Corto y Largo Plazo y en la Capacidad de Imaginación Motora

Susana Nunez Nagy4 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2021年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
4
主要终点
Manual task execution error measured in seconds by MATLAB.

研究概览

简要总结

In motor learning is essential 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. Several neural circuits have been identified that closely link the emotional system and the motion control system.

Arousal is associated with many emotional responses and has effects on the nervous and motor system. In line with the "Inverted 'U' Hypothesis", all levels of both high and low arousal do not allow optimal task performance, yet moderate levels lead to excellent performance. Arousal also plays a vital role in movement learning, where a critical element is memory. There is evidence that a minimum level of arousal is required to encode or record information and that that moderate levels of arousal improve memory.

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 different levels of arousal 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. For an effective and individualize MI program is imperative to know this capacity. However, how different levels of arousal can affect our motor imagery ability is also still unknown.

The main objective of this study is to determine and quantify the effects of arousal levels in 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 participants are subjected to different levels of arousal.

Researches expect that non-anxious, non-stressed participants who are shown images that elicit an optimal level of arousal will show better motor performance on the fine motor task and better motor imagery ability. In contrast, researches expect that participants without anxiety and stress who are shown pictures that elicit a sub-optimal level of arousal will show poorer motor performance on the fine motor task and poorer motor imagery ability.

详细描述

In order to meet the study objectives of determining and quantifying the effects of arousal levels 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 Alcala, the Complutense University of Madrid, or the European University of Madrid. 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 three intervention groups, in which low, medium, or high arousal will be induced, respectively. Each group will consist of a minimum number of 30 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 each participant meet the criteria for inclusion in the study. At this point, the participant will be coded and assigned a number, which will serve as identification throughout the study. Participants will take the State-Trait Anxiety Inventory (STAI), one of the most widely used instruments for the self-reported assessment of anxiety and equivalent to a measure of stress, as it considers the amount of stressful stimulus. Thus, the two components of anxiety will be assessed: state anxiety and trait anxiety. Participants with scores indicative of state or trait anxiety will be excluded from the study, and those with scores indicating neither trait anxiety nor state anxiety will be included. Included participants will be randomized through sealed envelopes stratified by gender to one of three experimental groups: low arousal, medium arousal, and high arousal. Participants will also take the Movement Imagery Questionnaire-3 (MIQ-3) to measure internal visual, external visual, kinaesthetic imagery ability, and the Edinburgh Handedness Inventory (EHI) to determine the participant's laterality. Depending on the group to which participants have been assigned, participants will be visualize a series of International Affective Picture System (IAPS) images that will induce the different states of arousal. The IAPS is one of the most widely used standardized emotion-eliciting stimulus sets in experimental research and has been shown to produce reliable and measurable changes in all three emotional response systems in the study population of this study: subjective-verbal, behavioral and physiological. After visualizing the images, participants will learn a precise manual task with the non-dominant hand. The task will consist of going over a 127 mm circumference on a graphics tablet at a rate of 2 seconds per lap, which will be set by a metronome using a wireless pen that will leave no trace of ink but will store the data in the MATLAB program via the graphics tablet. Thus, data from the learning process and short-term memory of the task will be recorded. Afterward, there will be a 20-minute break during which participants will perform the MIQ-3 again. Finally, the task data will be collected to record the long-term memory of the manual task.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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 State-Trait Anxiety Inventory scores corresponding to trait anxiety and state anxiety.
  • •Presence of localised skin lesion or disease in the wrist area.

研究组 & 干预措施

Low Arousal

Active Comparator

This group will see 25 affective images of the International Affective Picture System with low arousal level during 8-12 randomly seconds each one at time and with randomly rest of 8-12 seconds between images.

干预措施: Low Arousal (Other)

Medium Arousal

Active Comparator

This group will see 25 affective images of the International Affective Picture System with medium arousal level during 8-12 randomly seconds each one at time and with randomly rest of 8-12 seconds between images.

干预措施: Medium arousal (Other)

High Arousal

Active Comparator

This group will see 25 affective images of the International Affective Picture System with high arousal level during 8-12 randomly seconds each one at time and with randomly rest of 8-12 seconds between images.

干预措施: High arousal (Other)

结局指标

主要结局

Manual task execution error measured in seconds by MATLAB.

时间窗: During procedure

It shall be the inaccuracy committed by the subject in the tracing of the reference circumference. The dots per inch (dpi) or pixels per inch (pix) recorded in each lap from lap No. 1 to lap No. 20 shall be considered. It shall be recorded and measured by MATLAB.

Manual task execution time measured in seconds by MATLAB.

时间窗: During procedure

This is the time taken by the subject to execute a complete circumference. It shall be expressed in seconds (s). It shall be recorded and measured through MATLAB.

Execution Speed

时间窗: During procedure

This shall be the pixels drawn per unit of time. It shall be expressed in pixels per second (pix/s). It shall be recorded and measured by MATLAB.

Execution Accuracy

时间窗: During procedure

This refers to the dispersion of the set of values obtained from repeated measurements under the same conditions of the values of each of the laps. It shall be calculated as the ratio between the number of errors made divided by the execution speed from the previous data recorded in MATLAB. It shall be expressed in seconds: No. errors (pix) /V (pix/s) = (s).

Motor Imagery Ability

时间窗: Two points: Before procedure, resting period during procedure

This will be measured using the Movement Imagery Questionnaire-3, differentiating between the kinaesthetic, external visual and internal visual imagination subscales. Each subscale has 4 items and each item can be scored on a Likert scale from 1 to 7 points, where 1=very difficult to see/feel the movement and 7=very easy to see/feel the movement. Therefore, higher scores represent greater imaginative ability and each subscale can have a minimum of 4 points and a maximum of 28 points.

次要结局

  • Latency of the Electrodermal Activity(During procedure)
  • Heart Rate Variability(During procedure)
  • Heart Rate(During procedure)
  • Rise time of the Electrodermal Activity(During procedure)
  • Amplitude of the Electrodermal Activity(During procedure)
  • Interbeat Intervals(During procedure)

研究者

发起方
Susana Nunez Nagy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Susana Nunez Nagy

PhD. Associate Professor of Physiotherapy

University of Alcala

研究点 (4)

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