- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04548336
Mental Practice on Balance
September 7, 2020 updated by: Roy La Touche Arbizu, Universidad Autonoma de Madrid
Effects of Motor Imagery and Action Observation on Static and Dynamic Balance: A Randomized Controlled Trial
The main objective of this research is to see the effect of two mental practice techniques on static and dynamic balance.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Madrid, Spain, 28023
- CSEU La Salle
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 18 and 60
- Healthy and with no pain subjects
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
PLACEBO_COMPARATOR: Placebo group
|
This group will watch a video of nature without a human component.
|
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EXPERIMENTAL: Motor Imagery
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Motor imagery group will have to imagine motor gestures of static and dynamic balance
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EXPERIMENTAL: Action Observation
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Action observation group will have to observe static and dynamic equilibrium motor gestures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Posturography
Time Frame: Change in immediately at the end of the intervention.
|
The device is a robotic device that evaluates motor function and consists of wirelessly sensed electromechanical platforms.
This allows the evaluation of static and dynamic balance.
|
Change in immediately at the end of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The degree of physical activity
Time Frame: Immediately before the intervention
|
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
|
|
Visual and Kinesthetic Motor Imagery Ability
Time Frame: Immediately before the intervention
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
November 1, 2020
Primary Completion (ANTICIPATED)
March 30, 2021
Study Completion (ANTICIPATED)
June 30, 2021
Study Registration Dates
First Submitted
September 7, 2020
First Submitted That Met QC Criteria
September 7, 2020
First Posted (ACTUAL)
September 14, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 14, 2020
Last Update Submitted That Met QC Criteria
September 7, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- uammadrid33
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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