- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03902847
Motor Imagery and Action Observation on Lumbar Motor Variables
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain, 28023
- CSEU La Salle
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The inclusion criteria were as follows:
- asymptomatic participants
- men and women aged 18 to 65 years.
Exclusion Criteria:
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.
Study Plan
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 |
---|---|
EXPERIMENTAL: Motor imagery
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.
|
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.
|
EXPERIMENTAL: Action observation
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. |
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.
|
ACTIVE_COMPARATOR: Control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 week and 3 weeks
|
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
|
1 week and 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived fatigue: changes in the Visual Analogue Scale-fatigue mid-intervention
Time Frame: 1 week and 3 weeks.
|
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"
|
1 week and 3 weeks.
|
Changes in the trunk muscles strength
Time Frame: 1 week and 3 weeks.
|
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
|
1 week and 3 weeks.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Motor Activity
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)CompletedMotor Activity | Motor NeuroplasticityUnited States
-
Charles University, Czech RepublicRecruiting
-
Seattle Children's HospitalActive, not recruiting
-
Charles University, Czech RepublicActive, not recruiting
-
Riphah International UniversityCompleted
-
University of MichiganCompleted
-
University of TriesteCompleted
-
University Hospital, GrenobleUniversité Joseph Fourier; Centre National de la Recherche Scientifique, FranceCompleted
-
Rowe, Veronica, M.D.Completed
Clinical Trials on motor imagery
-
Abant Izzet Baysal UniversityRecruitingCerebral Palsy, SpasticTurkey
-
Ahmed Mahmoud KadryConcordia University WisconsinCompleted
-
Universidad Autonoma de MadridCompletedAnalgesia | ExerciseSpain
-
Seoul National University Bundang HospitalActive, not recruitingStroke | HemiplegiaKorea, Republic of
-
Universidad Autonoma de MadridCentro Universitario La SalleUnknown
-
National Yang Ming UniversityNot yet recruitingParkinson Disease | Movement Disorder, Functional
-
Dokuz Eylul UniversityIzmir Katip Celebi UniversityUnknownMotor Imagery Training | Physical Exercise | Orofacial ExerciseTurkey
-
Izmir Katip Celebi UniversityCompleted
-
Rigshospitalet, DenmarkCopenhagen Academy for Medical Education and SimulationActive, not recruitingBladder Cancer | Virtual Reality | EducationDenmark
-
Universidad Autonoma de MadridCentro Universitario La SalleUnknown