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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04548323
Other study ID # uammadrid32
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 30, 2020
Est. completion date July 30, 2021

Study information

Verified date September 2020
Source Universidad Autonoma de Madrid
Contact Roy A La Tocuhe, physiotherapist PhD
Phone 917401980
Email roylatouche@lasallecampus.es
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main objective is to identify the hypoalgesic effect of the imagination of actions in sedentary subjects with high levels of physical activity.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date July 30, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- asymptomatic participants

- men and women aged 18 to 65 years

Exclusion Criteria:

- insomnia

- nausea

- headache

- pregnancy

- use of painkillers in the last 24 hours

- presence of metal inside the head

- pacemaker

- wound on the area of electrodes' application

- drug consumption; (j) recent application of tDCS

- psychiatric disease impeding understanding of the study.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motor imagery
Subjects will perform motor imagery tasks on the motor gestures of running and walking.

Locations

Country Name City State
Spain CSEU La Salle Madrid

Sponsors (2)

Lead Sponsor Collaborator
Universidad Autonoma de Madrid Centro Universitario La Salle

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain pressure threshold Pressure Pain Threshold (PPT) is one of these tests and it is defined as the minimum force applied which induces pain. The measurement shall be carried out by using an algometer (pressure device that induces mechanical stimuli) is to standardize the amount of pressure applied in the neck region. The reliability of pressure pain thresholds according to raters or measurement frequencies is relatively high Change from baseline and immediately post-intervention
Primary Temporal sumation Temporal summation is a somatosensory measure that is performed by making small punctures in the area of interest. Change from baseline and immediately post-intervention
Primary Electrodermal activity Electrodermal Activity will be measured through the use of two electrodes that recorded changes in conductance through the skin located at the back of the dominant hand Change from baseline and immediately post-intervention
Primary Respiration Rate Respiration Rate will be measured through a pressure transducer located in the centre of the chest, where it was fixed by a strap. Change from baseline and immediately post-intervention
Primary Heart rate Heart Rate will be measured by three electrodes located in the left area of the chest. One of the electrodes was placed in the middle zone while a second electrode was positioned on the lateral side, and a third one on the lower left side, below the first electrode. Change from baseline and immediately post-intervention.
Primary Salivary stress The Salivary Stress Test is a study that assesses fatigue and the type of stress (acute, moderate or chronic) presented by the subject. Change from baseline and immediately post-intervention.
Secondary Visual and Kinesthetic Motor Imagery Ability Visual and Kinesthetic Motor Imagery Ability will be measured with Movement Imagery Questionnaire-Revised (MIQ-R). MIQ-R has four movements repeated in two subscales, a visual and a kinesthetic one. Additionally, a score between 1 and 7 is assigned, with 1 representing difficulty in picturing the motor image or difficulty in feeling the movement previously made, and 7 representing the maximum ease. The internal consistencies of the MIQ-R have been consistently adequate with Cronbach's a coefficients ranging above 0.84 for the total scale, 0.80 for de visual subscale and 0.84 for the kinesthetic subscale. Change from baseline and immediately post-intervention
Secondary The degree of physical activity The degree of physical activity was objectified through the The International Physical Activity Questionnaire (IPAQ) questionnaire, which allows the subjects to be divided into three groups according to their level of activity, which can be high, moderate, and low or inactive. The IPAQ consists of 7 questions about the frequency, duration and intensity of activity (moderate and intense) performed in the last seven days, as well as walking and sitting time on a workday. The IPAQ scoring protocol assigns the following MET values to walking, moderate, and vigorous intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively. Immediately before the intervention.
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