Autonomic Nervous System Clinical Trial
Official title:
Combining Motor Imagery With Action Observation Does Not Lead to a Greater Autonomic Response Than Motor Imagery Alone During Simple and Functional Movements: a Randomized Controlled Trial.
Verified date | February 2018 |
Source | Universidad Autonoma de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this study was to compare the activation of the Sympathetic Nervous System in a program that combined Motor Imagery with Action Observation, in contrast to an isolated Motor Imagery program on the one hand in asymptomatic subjects and in the other hand in patients with chronic low back pain.
Status | Completed |
Enrollment | 45 |
Est. completion date | June 30, 2017 |
Est. primary completion date | April 10, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria asymptomatic subjects: - Age between 18 and 60 - Healthy and with no pain subjects Inclusion Criteria patients with chronic low back pain: - Low back pain for at least the prior 3 months - Low back pain of nonspecific nature - Age between 18 and 60 - Low back pain for at least 10 days per month - Intensity of pain of between 3 and 10 on the Visual Analogue Scale Exclusion Criteria asymptomatic subjects: - Any cognitive impairment that hindered viewing of audiovisual material. - Difficulty understanding or communicating. - Presence of systemic pathology, Central Nervous System or rheumatic disease. - Inadequate understanding of the Spanish language to follow instructions for measuring and treatment. - Collaboration of pregnant women. - Underage subjects - Subjects with pain at the time of the study. Exclusion Criteria patients with chronic low back pain: - Any cognitive impairment that hindered viewing of audiovisual material. - Difficulty understanding or communicating. - Presence of systemic pathology, Central Nervous System or rheumatic disease. - Inadequate understanding of the Spanish language to follow instructions for measuring and treatment. - Collaboration of pregnant women. - Underage subjects - Having undergone back surgery - Specific spinal pathology - Recent trauma |
Country | Name | City | State |
---|---|---|---|
Spain | CSEU La Salle | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Autonoma de Madrid | Centro Universitario La Salle |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 in electrodermal activity after 5 minutes 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 in respiration rate after 5 minutes 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 in heart rate after 5 minutes post-intervention | |
Secondary | Visual and Kinesthetic Motor Imagery Ability | Visual and Kinesthetic Motor Imagery Ability will be measured with MIQ-R Questionnaire. MIQ-R has 4 movements repeated in two subscales, a visual and a kinaesthetic 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. A modification was made in the MIQ-R. Items 2 and 5, in which a small jump is made, were changed by standing on tiptoe. 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. | Pre-intervention | |
Secondary | Mental Chronometry | Mental chronometry evaluation was also used to measure the subject's motor imagery ability. Using a stopwatch, the time spent for performing each MIQ-R task was recorded. Time recorded corresponds to the interval between the command to start the task, given by the evaluator, and the verbal response of conclusion of the task, given by the subject. Mental chronometry is a reliable behavioral task that has previously been employed to collect an objective measure of MI ability | Pre-intervention | |
Secondary | The degree of physical activity | The degree of physical activity was objectified through the The International Physical Activity Questionnaire 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 | Pre-intervention |
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