Motor ActivityNCT03769974
Evaluation of Motor Learning on a Sequence of Manual Motor Gestures of Increasing Complexity Through the Mental Practise
A study testing Motor imagery and Action observation in people with Motor Activity, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
The main objective of this research is to evaluate and quantify successes and errors, as well as execution time, in a sequence of manual motor gestures of increasing complexity through mental practice training (observation of actions and motor imagery). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- 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
- 6 Dec 2018to 10 Aug 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- 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.
Spain1 site, 1 recruiting
- Recruiting
CSEU La Salle
Madrid, 28023
Roy La Touche, physiotherapist, 917401980 ext. 313, roylatouche@lasallecampus.es
About this study
Official title: Evaluation of Motor Learning on a Sequence of Manual Motor Gestures of Increasing Complexity Through the Action Observation Training and Motor Imagery: a Randomized Controlled Trial.
The main objective of this research is to evaluate and quantify successes and errors, as well as execution time, in a sequence of manual motor gestures of increasing complexity through mental practice training (observation of actions and motor imagery).
Read the detailed description
The motor programs stored in the procedural memory systems allow the generation of motor mental images without the need for an external stimulus, although it has been demonstrated that providing visual information, prior to a task of imagination, facilitates it and causes a greater neurophysiological activity than if it were done in an isolated manner. Some studies have shown that in the short term, in complex motor tasks of foot and hand in a coordinated manner, the action observation training provokes a greater motor learning compared to the motor imagery strategy.
However, these studies have only assessed short-term memory immediately after the intervention. No study has so far evaluated these improvements in motor learning through action observation training and motor imagery on consecutive days, nor has it been evaluated with short to medium-term follow-up.
It is therefore that there is a lack in the current scientific literature regarding which isolated method, without physical practice, of mental practice on motor learning is the most effective when exposed both on consecutive days, as well as to short-medium-term follow-up.
- Conditions
- Motor Activity
- Being tested
- Motor imagery, Action observation, Placebo intervention
- Keywords
- motor imagery, action observation, motor learning
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imageryBehavioural
Two series of 30 seconds training of motor imagery in each manual engine gesture
Action observationBehavioural
Two series of 30 seconds training of action observation training in video format in each manual engine gesture
Placebo interventionBehavioural
Two series of 30 seconds of observation and imagination of a landscape during for each manual motor sequence
| Study group | Role | What they receive |
|---|---|---|
| Motor imagery | Experimental | A group of healthy subjects who meet the inclusion and exclusion criteria established for the study to which a first-person kinesthetic motor imagery training will be conducted on a sequence of manual motor gestures of increasing complexity for four consecutive days. The tasks of motor imagery will be 2 series of 30 seconds for each of the 12 manual positions to remember Receives: Behavioral: Motor imagery |
| Action observation | Experimental | A group of healthy subjects who meet the inclusion and exclusion criteria established for the study to which a first-personaction observation training will be conducted on a sequence of manual motor gestures of increasing complexity for four consecutive days. The tasks of action observation will be 2 series of 30 seconds for each of the 12 manual positions to remember in video format. Receives: Behavioral: Action observation |
| Placebo group | Placebo comparator | A group of healthy subjects who meet the inclusion and exclusion criteria established for the study to which an imagery training and placebo observation, inspired by a rural landscape, will be given for four consecutive days. This group will carry out the observation and imagination of a landscape during 2 series of 30 seconds for each manual motor sequence to remember. Receives: Behavioral: Placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of successes in finger positions
During the measurements, the percentage of hits and errors achieved in each hand position in each of the manual engine sequences will be evaluated.
Measured: changes in the success rates at the end of the intervention, 7 days, 1 month and 4 months after the end of the intervention
Execution time
During each measurement, the time required for each participant to place their hands will be recorded.
Measured: changes in the success rates at the end of the intervention, 7 days, 1 month and 4 months after the end of the intervention
Secondary outcomes (5)
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 α coefficients ranging above 0.84 for the total scale, 0.80 for de visual subscale and 0.84 for the kinesthetic subscale.
Measured: Pre-intervention
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
Measured: Pre-intervention
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
Measured: Pre-intervention
Laterality task
With the task of recognition of the hand's laterality, two aspects will be evaluated: first, the precision (percentage of correct answers) of the discrimination of the laterality which is the capacity to recognize if a part of the body belongs to the right or left hemicorpse and second, the response time that the participants use in the task of discrimination or cognitive judgment. The app designed and developed by the NOI group will be used.
Measured: Pre-intervention
Memory Operation Questionnaire
The allows a cognitive evaluation of everyday memory failures. The questionnaire contains four subscales: daily memory, text recall, past memories and mnemonic strategies. The memory functioning questionnaire has adequate psychometric properties of validity and reliability obtained. An acceptable internal consistency was obtained, with a Cronbach alpha coefficient of the total scale of 0.818 memory operation questionnaire
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start6 Dec 2018
- Primary completion10 Jul 2019 (estimated)
- Study completion10 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roy La Touche Arbizu, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769974
- Sponsor's protocol ID
- 4
- Status last verified
- Mar 2019
- First submitted
- 6 Dec 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Motor Learning on a Sequence of Manual Motor Gestures of Increasing Complexity Through the Action Observation Training and Motor Imagery: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03769974
- Acronym / sponsor ID
- 4
- Conditions
- Motor Activity
- Keywords
- motor imagery, action observation, motor learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 10 Jul 2019 (estimated)
- Study completion
- 10 Aug 2019 (estimated)
- First posted
- 10 Dec 2018 (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 evaluate and quantify successes and errors, as well as execution time, in a sequence of manual motor gestures of increasing complexity through mental practice training (observation of actions and motor imagery).
Detailed description
The motor programs stored in the procedural memory systems allow the generation of motor mental images without the need for an external stimulus, although it has been demonstrated that providing visual information, prior to a task of imagination, facilitates it and causes a greater neurophysiological activity than if it were done in an isolated manner. Some studies have shown that in the short term, in complex motor tasks of foot and hand in a coordinated manner, the action observation training provokes a greater motor learning compared to the motor imagery strategy.
However, these studies have only assessed short-term memory immediately after the intervention. No study has so far evaluated these improvements in motor learning through action observation training and motor imagery on consecutive days, nor has it been evaluated with short to medium-term follow-up.
It is therefore that there is a lack in the current scientific literature regarding which isolated method, without physical practice, of mental practice on motor learning is the most effective when exposed both on consecutive days, as well as to short-medium-term follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motor imagery | Experimental | Behavioral: Motor imageryA group of healthy subjects who meet the inclusion and exclusion criteria established for the study to which a first-person kinesthetic motor imagery training will be conducted on a sequence of manual motor gestures of increasing complexity for four consecutive days. The tasks of motor imagery will be 2 series of 30 seconds for each of the 12 manual positions to remember |
| Action observation | Experimental | Behavioral: Action observationA group of healthy subjects who meet the inclusion and exclusion criteria established for the study to which a first-personaction observation training will be conducted on a sequence of manual motor gestures of increasing complexity for four consecutive days. The tasks of action observation will be 2 series of 30 seconds for each of the 12 manual positions to remember in video format. |
| Placebo group | Placebo comparator | Behavioral: Placebo interventionA group of healthy subjects who meet the inclusion and exclusion criteria established for the study to which an imagery training and placebo observation, inspired by a rural landscape, will be given for four consecutive days. This group will carry out the observation and imagination of a landscape during 2 series of 30 seconds for each manual motor sequence to remember. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 and 60
- Healthy and with no pain subjects
Key exclusion criteria (6 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.
- Underage subjects
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 imageryTwo series of 30 seconds training of motor imagery in each manual engine gesture | Behavioural | Motor imagery |
| Action observationTwo series of 30 seconds training of action observation training in video format in each manual engine gesture | Behavioural | Action observation |
| Placebo interventionTwo series of 30 seconds of observation and imagination of a landscape during for each manual motor sequence | Behavioural | Placebo group |
Primary outcome
Percentage of successes in finger positions
Time frame: changes in the success rates at the end of the intervention, 7 days, 1 month and 4 months after the end of the intervention
During the measurements, the percentage of hits and errors achieved in each hand position in each of the manual engine sequences will be evaluated.
Execution time
Time frame: changes in the success rates at the end of the intervention, 7 days, 1 month and 4 months after the end of the intervention
During each measurement, the time required for each participant to place their hands will be recorded.
5 secondary outcomes
Visual and Kinesthetic Motor Imagery Ability
Time frame: Pre-intervention
Mental Chronometry
Time frame: Pre-intervention
The degree of physical activity
Time frame: Pre-intervention
Laterality task
Time frame: Pre-intervention
Memory Operation Questionnaire
Time frame: Pre-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: No
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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 Motor Activity, 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 6 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 29 Mar 2019. 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 La Touche, 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?
Percentage of successes in finger positions (time frame: changes in the success rates at the end of the intervention, 7 days, 1 month and 4 months after the end of the intervention). The study lists 2 primary outcomes in all. 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 29 Mar 2019.