Asymptomatic SubjectsNCT03324217
Effects of Motor Imagery and Action Observation on Electromyographic Activity and Intramuscular Oxygenation in the Hand Gripping Gesture
A study testing Mental Practise in people with Asymptomatic Subjects and Painfree Voluntiers, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
Motor imagery is defined as a dynamic mental process of an action, without its real motor execution. Action observation training consists of watching an action performed by someone else. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Subjects, Painfree Voluntiers, Neuroscience
- What is being tested?
- Mental Practise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2017to 13 Oct 2017
- 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
- asymptomatic participants;
- men and women aged 18 to 65 years.
Who cannot join
- participants who had any knowledge of physical therapy;
- underage participants;
- participants with pain at the time of the study;
- participants with any type of neurological disease.
Trial locations and contacts
1 site in 1 country.
About this study
Motor imagery is defined as a dynamic mental process of an action, without its real motor execution. Action observation training consists of watching an action performed by someone else. The primary objective of this study was to evaluate the effects of motor imagery and action observation combined with a hand grip strength program on strength gains in asymptomatic participants. The secondary objective was to assess the influence of motor imagery and action observation training combined with a hand grip strength program on electromyographic activity and intramuscular oxygenation of the forearm muscles.
Read the detailed description
Motor imagery is defined as a dynamic mental process of an action, without its real motor execution. Action observation training consists of watching an action performed by someone else. Both motor imagery and action observation have been shown to produce a neurophysiological activation of the brain areas related to the planning and execution of voluntary movement in a manner that resembles how the action is performed in reality.
Several studies have shown that patients can report a significant improvement in strength with motor imagery training. There is also evidence regarding the improvements in motor skills in participants who perform motor imagery training combined with mirror therapy. Motor imagery is recognized as one of the most popular and effective forms of training to improve learning strategies and to increase the capacity to perfect sports movements, as has been observed in rhythmic gymnastics athletes.
In addition to the previously mentioned adaptations, a recent research proved that motor imagery and action observation provoke an activation of the sympathetic-excitatory nervous system. Changes in respiration, heart rate and skin temperature are produced, as well as an increase in electrodermal activity.
Both motor imagery and action observation are interventions that can generate adaptive neuroplastic changes on a cortical level, leading to a decrease in chronic pain. These rehabilitation techniques are used in pain treatment and impaired movement injuries that could be due to a nervous system alteration.
Action observation effectively facilitates motor learning, and is a tool for rehabilitation in neurological and musculoskeletal diseases. Action observation training leads to significant improvements in static balance and helps improve gait in patients with hemiparesis after an ictus.
A recent study showed that the patient's functionality loss is lessened if motor imagery and action observation are applied after an immobilization process, reducing the loss of wrist mobility, strength and muscle mass.
The effectiveness of motor imagery is controversial; several studies have presented unfavorable outcomes from this technique. Some variables, such as the duration of the sessions, the time employed the type of motor task or the number of sessions can influence the outcomes of these studies. Thus, it is necessary to clarify the controversial aspects of motor imagery, which lead us to perform this study.
This study evaluates variables that have not yet shown conclusive results: intramuscular oxygenation and electromyography. Focusing principally on the effectiveness of the treatment and the adaptations that are generated on an intramuscular level leads to a better understanding of what occurs as a result of training with motor imagery and action observation, and also whether these variables influence the effectiveness of the treatment.
Therefore, the primary objective of this study was to evaluate the effects of motor imagery and action observation combined with a hand grip strength program on strength gains in asymptomatic participants. The secondary objective was to assess the influence of motor imagery and action observation training combined with a hand grip strength program on electromyographic activity and intramuscular oxygenation of the forearm muscles.
- Conditions
- Asymptomatic Subjects, Painfree Voluntiers, Neuroscience
- Being tested
- Mental Practise
- Keywords
- motor imagery, action observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental PractiseOther
Also called Mental Task
They made a mental task to produce a neurophysiological activation of the brain areas related to the planning and execution of voluntary movement in a manner that resembles how the action is performed in reality in combination with real exercises.
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery Group | Experimental | The participants in the motor imagery group were given instructions to perform a daily training composed of two sets of activities. The main set consisted of 10 isometric hand grip contractions for 3 seconds each with a tennis ball, leaving a 20-second break between contractions. In the first set, the participant only had to imagine that he was performing that task, placed in the standard position with the tennis ball in the hand. Once the first set was completed, the participant had to take a 2-minute break before starting the second set, in which they had to complete the set both imagining and actively performing the isometric contractions with the tennis ball. Receives: Other: Mental Practise |
| Action Observation Group | Experimental | The participants in the action observation group were given instructions to perform a daily training comprised of two sets of activities. The main set consisted of 10 isometric hand grip contractions for 3 seconds each with a tennis ball, leaving a 20-second break between contractions. In the first set, the participant simply watched a video that showed a forearm performing the task, placed in the standard position and with the tennis ball in the hand. Once that first set was completed, the participant took a 2-minute break before starting the second set, in which they performed the 10 isometric contractions with the tennis ball while they watched the video. Receives: Other: Mental Practise |
| Control Group | Active comparator | The participants in the control group were given instructions to perform a daily training of a single set. The set consisted of 10 isometric hand grip contractions for 3 seconds each with a tennis ball, leaving a 20-second break between contractions. Receives: Other: Mental Practise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The hand grip strength
The hand grip strength in kilograms was assessed using a Jamar dynamometer with the standard protocols for hand grip training. The measurements with the Jamar dynamometer present excellent test-retest reliability (intraclass correlation coefficient [ICC] = 0.81-0.99) for preferred and nonpreferred hands in men and excellent test-retest reliability (ICC = 0.83-1.0) for preferred and nonpreferred hands in women. The Jamar Dynamometer presents excellent intra-rater reliability (ICC = 0.94 and 0.98) and excellent inter-rater reliability (ICC = 0.98 for right and left handgrip strength).
Measured: Change in hand grip strength after 72 hours post-intervention
Secondary outcomes (2)
Intramuscular oxygenation
The intramuscular oxygenation of the extensor muscles of the forearm was measured with the Moxy Monitor System. The Moxy sensor is placed over the muscle bellies of the extensor carpi radialis longus and the extensor carpi radialis brevis and measures the intramuscular oxygenation through a continuous infrared light emission.
Measured: Change in Intramuscular oxygenation after 72 hours post-intervention
Electromyographic activity
The electromyographic activity of the extensor muscles of the forearm was measured on the bellies of the extensor carpi radialis longus and the extensor carpi radialis brevis, placing the two electrodes in each of the muscle bellies, and a fifth electrode over the olecranon, which acts as a grounding. The Physioplux system was used for muscle contraction capture.
Measured: Change in Electromyographic activity after 72 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Jun 2017
- Primary completion11 Sep 2017
- Study completion13 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic SubjectsStudies 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
- Investigator
- Enrolment
- 60 participants (actual)
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
- Investigators
- Roy A La Touche, PT, PhD, Study director, Departamento de Fisioterapia. Centro Superior de Estudios Universitarios de La Salle. Universidad Autónoma de Madrid. Madrid. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324217
- Sponsor's protocol ID
- uamadrid 3
- Status last verified
- Oct 2017
- First submitted
- 20 Oct 2017
- Last updated
- 30 Oct 2017
- 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 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Imagery and Action Observation on Electromyographic Activity and Intramuscular Oxygenation in the Hand Gripping Gesture
- ClinicalTrials.gov ID
- NCT03324217
- Acronym / sponsor ID
- uamadrid 3
- Conditions
- Asymptomatic Subjects, Painfree Voluntiers, Neuroscience
- Keywords
- motor imagery, action observation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 13 Oct 2017 (actual)
- First posted
- 27 Oct 2017 (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.
Motor imagery is defined as a dynamic mental process of an action, without its real motor execution. Action observation training consists of watching an action performed by someone else. The primary objective of this study was to evaluate the effects of motor imagery and action observation combined with a hand grip strength program on strength gains in asymptomatic participants. The secondary objective was to assess the influence of motor imagery and action observation training combined with a hand grip strength program on electromyographic activity and intramuscular oxygenation of the forearm muscles.
Detailed description
Motor imagery is defined as a dynamic mental process of an action, without its real motor execution. Action observation training consists of watching an action performed by someone else. Both motor imagery and action observation have been shown to produce a neurophysiological activation of the brain areas related to the planning and execution of voluntary movement in a manner that resembles how the action is performed in reality.
Several studies have shown that patients can report a significant improvement in strength with motor imagery training. There is also evidence regarding the improvements in motor skills in participants who perform motor imagery training combined with mirror therapy. Motor imagery is recognized as one of the most popular and effective forms of training to improve learning strategies and to increase the capacity to perfect sports movements, as has been observed in rhythmic gymnastics athletes.
In addition to the previously mentioned adaptations, a recent research proved that motor imagery and action observation provoke an activation of the sympathetic-excitatory nervous system. Changes in respiration, heart rate and skin temperature are produced, as well as an increase in electrodermal activity.
Both motor imagery and action observation are interventions that can generate adaptive neuroplastic changes on a cortical level, leading to a decrease in chronic pain. These rehabilitation techniques are used in pain treatment and impaired movement injuries that could be due to a nervous system alteration.
Action observation effectively facilitates motor learning, and is a tool for rehabilitation in neurological and musculoskeletal diseases. Action observation training leads to significant improvements in static balance and helps improve gait in patients with hemiparesis after an ictus.
A recent study showed that the patient's functionality loss is lessened if motor imagery and action observation are applied after an immobilization process, reducing the loss of wrist mobility, strength and muscle mass.
The effectiveness of motor imagery is controversial; several studies have presented unfavorable outcomes from this technique. Some variables, such as the duration of the sessions, the time employed the type of motor task or the number of sessions can influence the outcomes of these studies. Thus, it is necessary to clarify the controversial aspects of motor imagery, which lead us to perform this study.
This study evaluates variables that have not yet shown conclusive results: intramuscular oxygenation and electromyography. Focusing principally on the effectiveness of the treatment and the adaptations that are generated on an intramuscular level leads to a better understanding of what occurs as a result of training with motor imagery and action observation, and also whether these variables influence the effectiveness of the treatment.
Therefore, the primary objective of this study was to evaluate the effects of motor imagery and action observation combined with a hand grip strength program on strength gains in asymptomatic participants. The secondary objective was to assess the influence of motor imagery and action observation training combined with a hand grip strength program on electromyographic activity and intramuscular oxygenation of the forearm muscles.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery Group | Experimental | Other: Mental PractiseThe participants in the motor imagery group were given instructions to perform a daily training composed of two sets of activities. The main set consisted of 10 isometric hand grip contractions for 3 seconds each with a tennis ball, leaving a 20-second break between contractions. In the first set, the participant only had to imagine that he was performing that task, placed in the standard position with the tennis ball in the hand. Once the first set was completed, the participant had to take a 2-minute break before starting the second set, in which they had to complete the set both imagining and actively performing the isometric contractions with the tennis ball. |
| Action Observation Group | Experimental | Other: Mental PractiseThe participants in the action observation group were given instructions to perform a daily training comprised of two sets of activities. The main set consisted of 10 isometric hand grip contractions for 3 seconds each with a tennis ball, leaving a 20-second break between contractions. In the first set, the participant simply watched a video that showed a forearm performing the task, placed in the standard position and with the tennis ball in the hand. Once that first set was completed, the participant took a 2-minute break before starting the second set, in which they performed the 10 isometric contractions with the tennis ball while they watched the video. |
| Control Group | Active comparator | Other: Mental PractiseThe participants in the control group were given instructions to perform a daily training of a single set. The set consisted of 10 isometric hand grip contractions for 3 seconds each with a tennis ball, leaving a 20-second break between contractions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- asymptomatic participants;
- men and women aged 18 to 65 years.
Key exclusion criteria (4 listed)
- participants who had any knowledge of physical therapy;
- underage participants;
- participants with pain at the time of the study;
- participants with any type of neurological disease.
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 |
|---|---|---|
| Mental PractiseAlso: Mental TaskThey made a mental task to produce a neurophysiological activation of the brain areas related to the planning and execution of voluntary movement in a manner that resembles how the action is performed in reality in combination with real exercises. | Other | Action Observation Group, Control Group, Motor Imagery Group |
Primary outcome
The hand grip strength
Time frame: Change in hand grip strength after 72 hours post-intervention
The hand grip strength in kilograms was assessed using a Jamar dynamometer with the standard protocols for hand grip training. The measurements with the Jamar dynamometer present excellent test-retest reliability (intraclass correlation coefficient [ICC] = 0.81-0.99) for preferred and nonpreferred hands in men and excellent test-retest reliability (ICC = 0.83-1.0) for preferred and nonpreferred hands in women. The Jamar Dynamometer presents excellent intra-rater reliability (ICC = 0.94 and 0.98) and excellent inter-rater reliability (ICC = 0.98 for right and left handgrip strength).
2 secondary outcomes
Intramuscular oxygenation
Time frame: Change in Intramuscular oxygenation after 72 hours post-intervention
Electromyographic activity
Time frame: Change in Electromyographic activity after 72 hours post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- 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.
Roy A La Touche, PT, PhD study director
Departamento de Fisioterapia. Centro Superior de Estudios Universitarios de La Salle. Universidad Autónoma de Madrid. Madrid. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Practise in people with Asymptomatic Subjects and Painfree Voluntiers, 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 4 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: finished, as of the sponsor's last update on 30 Oct 2017. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The hand grip strength (time frame: Change in hand grip strength after 72 hours post-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 30 Oct 2017.