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Mental Practice on Balance

Primary Purpose

Movement, Involuntary

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Motor Imagery
Action observation
Placebo group
Sponsored by
Universidad Autonoma de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Movement, Involuntary focused on measuring Motor imagery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CSEU La Salle

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Motor Imagery

Action Observation

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

Posturography
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.

Secondary Outcome Measures

Visual and Kinesthetic Motor Imagery Ability
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.
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.

Full Information

First Posted
September 7, 2020
Last Updated
September 7, 2020
Sponsor
Universidad Autonoma de Madrid
Collaborators
Centro Universitario La Salle
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1. Study Identification

Unique Protocol Identification Number
NCT04548336
Brief Title
Mental Practice on Balance
Official Title
Effects of Motor Imagery and Action Observation on Static and Dynamic Balance: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Madrid
Collaborators
Centro Universitario La Salle

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The main objective of this research is to see the effect of two mental practice techniques on static and dynamic balance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Movement, Involuntary
Keywords
Motor imagery

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motor Imagery
Arm Type
Experimental
Arm Title
Action Observation
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Motor Imagery
Intervention Description
Motor imagery group will have to imagine motor gestures of static and dynamic balance
Intervention Type
Behavioral
Intervention Name(s)
Action observation
Intervention Description
Action observation group will have to observe static and dynamic equilibrium motor gestures
Intervention Type
Behavioral
Intervention Name(s)
Placebo group
Intervention Description
This group will watch a video of nature without a human component.
Primary Outcome Measure Information:
Title
Posturography
Description
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.
Time Frame
Change in immediately at the end of the intervention.
Secondary Outcome Measure Information:
Title
Visual and Kinesthetic Motor Imagery Ability
Description
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.
Time Frame
Immediately before the intervention
Title
The degree of physical activity
Description
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.
Time Frame
Immediately before the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roy A La Tocuhe, physiotherapist PhD
Phone
917401980
Ext
313
Email
roylatouche@lasallecampus.es
Facility Information:
Facility Name
CSEU La Salle
City
Madrid
ZIP/Postal Code
28023
Country
Spain

12. IPD Sharing Statement

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Mental Practice on Balance

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