NCT03902847

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

March 29, 2019

Last Update Submit

April 2, 2019

Conditions

Keywords

motor imageryaction observationmotor learning

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    1 week and 3 weeks

Secondary Outcomes (2)

  • Perceived fatigue: changes in the Visual Analogue Scale-fatigue mid-intervention

    1 week and 3 weeks.

  • Changes in the trunk muscles strength

    1 week and 3 weeks.

Study Arms (3)

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.

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.

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.

Behavioral: Motor Control Exercises

Interventions

motor imageryBEHAVIORAL

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.

Motor imagery

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.

Action observation

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.

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • asymptomatic participants
  • men and women aged 18 to 65 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSEU La Salle

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 4, 2019

Study Start

February 1, 2018

Primary Completion

May 30, 2018

Study Completion

December 1, 2018

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations