Movement, InvoluntaryNCT04548336
Mental Practice on Balance
A study testing Motor Imagery and Action observation in people with Movement, Involuntary, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
The main objective of this research is to see the effect of two mental practice techniques on static and dynamic balance. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Movement, Involuntary
- What is being tested?
- Motor Imagery and Action observation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 60
- Healthy and with no pain subjects
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Movement, Involuntary
- Being tested
- Motor Imagery, Action observation, Placebo group
- Keywords
- Motor imagery
- Medical subject headings
- Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor ImageryBehavioural
Motor imagery group will have to imagine motor gestures of static and dynamic balance
Action observationBehavioural
Action observation group will have to observe static and dynamic equilibrium motor gestures
Placebo groupBehavioural
This group will watch a video of nature without a human component.
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery | Experimental | Not described Receives: Behavioral: Motor Imagery |
| Action Observation | Experimental | Not described Receives: Behavioral: Action observation |
| Placebo group | Placebo comparator | Not described Receives: Behavioral: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in immediately at the end of the intervention.
Secondary outcomes (2)
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.
Measured: Immediately before the intervention
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.
Measured: Immediately before the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Nov 2020 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement, InvoluntaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitario La Salle
- Responsible party
- Principal investigator, Roy La Touche Arbizu, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548336
- Sponsor's protocol ID
- uammadrid33
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Imagery and Action Observation on Static and Dynamic Balance: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04548336
- Acronym / sponsor ID
- uammadrid33
- Conditions
- Movement, Involuntary
- Keywords
- Motor imagery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Centro Universitario La Salle
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this research is to see the effect of two mental practice techniques on static and dynamic balance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery | Experimental | Behavioral: Motor Imagery |
| Action Observation | Experimental | Behavioral: Action observation |
| Placebo group | Placebo comparator | Behavioral: Placebo group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 60
- Healthy and with no pain subjects
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor ImageryMotor imagery group will have to imagine motor gestures of static and dynamic balance | Behavioural | Motor Imagery |
| Action observationAction observation group will have to observe static and dynamic equilibrium motor gestures | Behavioural | Action Observation |
| Placebo groupThis group will watch a video of nature without a human component. | Behavioural | Placebo group |
Primary outcome
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.
2 secondary outcomes
Visual and Kinesthetic Motor Imagery Ability
Time frame: Immediately before the intervention
The degree of physical activity
Time frame: Immediately before the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery and Action observation in people with Movement, Involuntary, run by Universidad Autonoma de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roy A La Tocuhe, physiotherapist PhD (917401980 ext. 313, roylatouche@lasallecampus.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posturography (time frame: Change in immediately at the end of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.