Motor ActivityNCT03902847
Motor Imagery and Action Observation on Lumbar Motor Variables
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
Motor imagery is defined as a dynamic mental process of an action, without its real motor execution. Action observation evokes an internal, real-time motor simulation of the movements that the observer is perceiving visually. Read more about this study
- Who is it for?
- Ages 18 to 65 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?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2018to 1 Dec 2018
- 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
- The inclusion criteria were as follows:
- asymptomatic participants
- men and women aged 18 to 65 years.
Who cannot join
- The exclusion criteria included the following:
- participants who had any knowledge of Physical Therapy or Occupational Therapy
- underage participants
- participants with any symptomatology in the lumbo-pelvic region at the time of the study -participants with lumbo-pelvic pain in at least the prior six months
- subjects who have been treated for lumbo-pelvic pain in the previous 6 months
- participants with any type of neurological disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Intensive Exercise Program Combined With Training on Action Observation and Motor Imagery for Improving Lumbopelvic Motor Control and Strengthening Trunk Muscles: A Randomized Controlled Trial
Motor imagery is defined as a dynamic mental process of an action, without its real motor execution. Action observation evokes an internal, real-time motor simulation of the movements that the observer is perceiving visually. Both MI and AO have been shown to produce a neurophysiological activation of the brain areas related to the planning and execution of voluntary movement in a similar manner how the real action.
- Conditions
- Motor Activity
- Being tested
- motor imagery, Action observation, Motor Control Exercises
- 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
All subjects had to imagine that he/she was performing each exercise during 1 set of 12 repetitions prior to the real execution of this. During the second phase (the second and third week), subjects had to complete the set both imagining, with visual mental motor imagery, and actively performing the exercises.
Action observationBehavioural
A video was shown in third-person perspective. All subjects watched one person performing each exercise during 1 set of 12 repetitions. During the second phase (the second and third week), subjects had to perform actively the exercises while they watched the video.
Motor Control ExercisesBehavioural
The subjects were asked to perform 3 sets, of 10-12 repetitions each six exercise, with a total duration of approximately 30-35 minutes. The exercises program had to do it once a day, 6 days a week, for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Motor imagery | Experimental | All the subjects in this group were informed of the procedure at the beginning of the intervention, which consisted of the following: in the first phase (the first week), all participants had to perform the same motor control exercises program than the control group, but previously, a mental practice based on kinesthetic mental motor imagery was performed. To reinforce the process of motor imagery, a video with the exercises was shown to the subjects before performing the mental practice. All subjects had to imagine that he/she was performing each exercise during 1 set of 12 repetitions prior to the real execution of this. During the second phase (the second and third week), subjects had to complete the set both imagining, with visual mental motor imagery, and actively performing the exercises. Receives: Behavioral: motor imagery |
| Action observation | Experimental | All the subjects in this group were informed of the procedure at the beginning of the intervention, which consisted of the following: in the first phase (the first week), all participants had to perform the same motor control exercises program than the control group, but prior to the real execution, a video was shown in third-person perspective. All subjects watched one person performing each exercise during 1 set of 12 repetitions. During the second phase (the second and third week), subjects had to perform actively the exercises while they watched the video.
All the participants also received a booklet with written information about the indications and exercises to be practiced at home to ensure that the training program was performed properly. Each week, participants received messages to remind and motivate them to undertake the exercise program daily. Receives: Behavioral: Action observation |
| Control group | Active comparator | The subjects in this group received an intensive training program based on stabilization exercises of lumbo-pelvic region, which are common exercises used in rehabilitation of patients with chronic non-specific low back pain. Receives: Behavioral: Motor Control Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Right Lumbo-pelvic motor control
Lumbar motor control will be measured by a pressure biofeedback called Stabilizer TM. The measurement protocol in the following procedure; The patient should be supine position with the Stabilizer TM placed in the lumbar region with an initial pressure of 70 mmHg. Then, the patient will be asked to flex the hip and knee at 90 ° with one leg and then with the opposite one. It is a validated and reliable protocol for motor control of the lumbar region
Measured: 1 week and 3 weeks
Changes in the Left Lumbo-pelvic motor control
Lumbar motor control will be measured by a pressure biofeedback called Stabilizer TM. The measurement protocol in the following procedure; The patient should be supine position with the Stabilizer TM placed in the lumbar region with an initial pressure of 70 mmHg. Then, the patient will be asked to flex the hip and knee at 90 ° with one leg and then with the opposite one. It is a validated and reliable protocol for motor control of the lumbar region
Measured: 1 week and 3 weeks
Secondary outcomes (2)
Perceived fatigue: changes in the Visual Analogue Scale-fatigue mid-intervention
Perceived fatigue will be measured with Visual Analogue Scale (VAS). The VAS consists of a 100-mm line, the left side of which represents "no fatigue" whereas the right side represents "maximal fatigue"
Measured: 1 week and 3 weeks.
Changes in the trunk muscles strength
The strength of the lumbar region will be measured by a foot dynamometer (Takei TM 5420). The patient should stand on the dynamometer platform with knees extended, elbows extended, hips bent and index fingers holding the bar at knee height. Starting from this position the subject will have to make a previous adjustment of contraction of the musculature of the lumbar region and must perform a movement of lumbar extension. Subjects should maintain contraction for 3 seconds. It is a valid and reliable test to measure the muscular strength of the lumbar region
Measured: 1 week and 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Feb 2018
- Primary completion30 May 2018
- Study completion1 Dec 2018
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902847
- Sponsor's protocol ID
- 5
- Status last verified
- Apr 2019
- First submitted
- 29 Mar 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- 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 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Intensive Exercise Program Combined With Training on Action Observation and Motor Imagery for Improving Lumbopelvic Motor Control and Strengthening Trunk Muscles: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03902847
- Acronym / sponsor ID
- 5
- Conditions
- Motor Activity
- Keywords
- motor imagery, action observation, motor learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 4 Apr 2019 (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 evokes an internal, real-time motor simulation of the movements that the observer is perceiving visually. Both MI and AO have been shown to produce a neurophysiological activation of the brain areas related to the planning and execution of voluntary movement in a similar manner how the real action.
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 | Experimental | Behavioral: motor imageryAll the subjects in this group were informed of the procedure at the beginning of the intervention, which consisted of the following: in the first phase (the first week), all participants had to perform the same motor control exercises program than the control group, but previously, a mental practice based on kinesthetic mental motor imagery was performed. To reinforce the process of motor imagery, a video with the exercises was shown to the subjects before performing the mental practice. All subjects had to imagine that he/she was performing each exercise during 1 set of 12 repetitions prior to the real execution of this. During the second phase (the second and third week), subjects had to complete the set both imagining, with visual mental motor imagery, and actively performing the exercises. |
| Action observation | Experimental | Behavioral: Action observationAll the subjects in this group were informed of the procedure at the beginning of the intervention, which consisted of the following: in the first phase (the first week), all participants had to perform the same motor control exercises program than the control group, but prior to the real execution, a video was shown in third-person perspective. All subjects watched one person performing each exercise during 1 set of 12 repetitions. During the second phase (the second and third week), subjects had to perform actively the exercises while they watched the video. All the participants also received a booklet with written information about the indications and exercises to be practiced at home to ensure that the training program was performed properly. Each week, participants received messages to remind and motivate them to undertake the exercise program daily. |
| Control group | Active comparator | Behavioral: Motor Control ExercisesThe subjects in this group received an intensive training program based on stabilization exercises of lumbo-pelvic region, which are common exercises used in rehabilitation of patients with chronic non-specific low back pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- asymptomatic participants
- men and women aged 18 to 65 years.
Key exclusion criteria (6 listed)
- participants who had any knowledge of Physical Therapy or Occupational Therapy
- underage participants
- participants with any symptomatology in the lumbo-pelvic region at the time of the study -participants with lumbo-pelvic pain in at least the prior six months
- subjects who have been treated for lumbo-pelvic pain in the previous 6 months
- 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 |
|---|---|---|
| motor imageryAll subjects had to imagine that he/she was performing each exercise during 1 set of 12 repetitions prior to the real execution of this. During the second phase (the second and third week), subjects had to complete the set both imagining, with visual mental motor imagery, and actively performing the exercises. | Behavioural | Motor imagery |
| Action observationA video was shown in third-person perspective. All subjects watched one person performing each exercise during 1 set of 12 repetitions. During the second phase (the second and third week), subjects had to perform actively the exercises while they watched the video. | Behavioural | Action observation |
| Motor Control ExercisesThe subjects were asked to perform 3 sets, of 10-12 repetitions each six exercise, with a total duration of approximately 30-35 minutes. The exercises program had to do it once a day, 6 days a week, for 3 weeks. | Behavioural | Control group |
Primary outcome
Changes in the Right Lumbo-pelvic motor control
Time frame: 1 week and 3 weeks
Lumbar motor control will be measured by a pressure biofeedback called Stabilizer TM. The measurement protocol in the following procedure; The patient should be supine position with the Stabilizer TM placed in the lumbar region with an initial pressure of 70 mmHg. Then, the patient will be asked to flex the hip and knee at 90 ° with one leg and then with the opposite one. It is a validated and reliable protocol for motor control of the lumbar region
Changes in the Left Lumbo-pelvic motor control
Time frame: 1 week and 3 weeks
Lumbar motor control will be measured by a pressure biofeedback called Stabilizer TM. The measurement protocol in the following procedure; The patient should be supine position with the Stabilizer TM placed in the lumbar region with an initial pressure of 70 mmHg. Then, the patient will be asked to flex the hip and knee at 90 ° with one leg and then with the opposite one. It is a validated and reliable protocol for motor control of the lumbar region
2 secondary outcomes
Perceived fatigue: changes in the Visual Analogue Scale-fatigue mid-intervention
Time frame: 1 week and 3 weeks.
Changes in the trunk muscles strength
Time frame: 1 week and 3 weeks.
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 4 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 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: finished, as of the sponsor's last update on 4 Apr 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. 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?
Changes in the Right Lumbo-pelvic motor control (time frame: 1 week and 3 weeks). 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 4 Apr 2019.