NCT03959449

Brief Summary

This study evaluates the influence of motor imagery and the observation of actions on pain perception. Participants in this study are asymptomatic subjects who will perform an IM and AO protocol of an aerobic exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

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

First Submitted

Initial submission to the registry

May 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

June 5, 2019

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

25 days

First QC Date

May 20, 2019

Last Update Submit

July 19, 2019

Conditions

Keywords

Motor imageryAction observationHypoalgesia

Outcome Measures

Primary Outcomes (1)

  • Pain pressure threshold

    Pressure Pain Threshold (PPT) is one of these tests and it is defined as the minimum force applied which induces pain. The measurement shall be carried out by using an algometer (pressure device that induces mechanical stimuli) is to standardize the amount of pressure applied in the neck region. The reliability of pressure pain thresholds according to raters or measurement frequencies is relatively high

    Change from baseline and immediately post-intervention

Secondary Outcomes (6)

  • Visual and Kinesthetic Motor Imagery Ability

    Immediately before the intervention

  • The degree of physical activity

    Immediately before the intervention

  • Kinesiophobia

    Immediately before the intervention

  • Electrodermal Activity

    Change in electrodermal activity after 5 minutes post-intervention

  • Respiration Rate

    Change in electrodermal activity after 5 minutes post-intervention

  • +1 more secondary outcomes

Study Arms (3)

Action Observation and Motor imagery

EXPERIMENTAL
Behavioral: Action Observation plus motor imagery

Motor Imagery

ACTIVE COMPARATOR
Behavioral: Motor imagery

Exercise plus motor imagery and action observation

EXPERIMENTAL
Behavioral: Exercise plus action Observation and motor imagery

Interventions

Action observation (video) and motor imagery of running.

Action Observation and Motor imagery
Motor imageryBEHAVIORAL

Motor imagery of running

Motor Imagery

Real exercise of running during 6 min plus action observation (video) and motor imagery of running.

Exercise plus motor imagery and action observation

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 60
  • Healthy and with no pain subjects

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSEU La Salle

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

AgnosiaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 22, 2019

Study Start

June 5, 2019

Primary Completion

June 30, 2019

Study Completion

July 15, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations