- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545684
Effects of Mental Practice on Manual Gripping Motor Function
November 3, 2020 updated by: Roy La Touche Arbizu, Universidad Autonoma de Madrid
Effects of Mental Practice on Manual Gripping Motor Function: A Randomized Controlled Trial
The main objective is to evaluate and quantify the manual gripping force caused by mental practice
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
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
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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
|
The placebo group will imagine a place without the presence of humans.
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EXPERIMENTAL: Mental practice
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The person will have to imagine different scenarios of manual gripping
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain pressure threshold
Time Frame: Change from baseline and immediately post-intervention
|
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
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Hand grip strength
Time Frame: Change from baseline and immediately post-intervention
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It is a variable of gripping force measured in the unit of Newtons
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Change from baseline and immediately post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual and Kinesthetic Motor Imagery Ability
Time Frame: Immediately before the intervention
|
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 α coefficients ranging above 0.84 for the total scale, 0.80 for de visual subscale and 0.84 for the kinesthetic subscale.
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Immediately before the intervention
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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.
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Immediately before the intervention.
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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 30, 2020
Primary Completion (ANTICIPATED)
December 30, 2020
Study Completion (ANTICIPATED)
February 26, 2021
Study Registration Dates
First Submitted
September 4, 2020
First Submitted That Met QC Criteria
September 10, 2020
First Posted (ACTUAL)
September 11, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- uammadrid31
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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