- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03232879
Combining Motor Imagery With Action Observation Does Not Lead to a Greater Autonomic Response Than Motor Imagery Alone During Simple and Functional Movements: a Randomized Controlled Trial.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Motor Imagery (MI) is defined as a dynamic mental process that involves the representation of an action, in an internal way, without its actual motor execution. The Action Observation (AO) evokes an internal, real-time motor simulation of the movements that the observer is perceiving visually. Both mental processes trigger the activation of the neurocognitive mechanisms that underlie the planning and execution of voluntary movements in a manner that resembles how the action is performed in a real manner.
Both observation and imagination share a great number of common mental processes based primarily on sensory perception, and the information stored by memory systems. The activation of the motor command during a mental practice does not induce an active movement probably due to an inhibitory mechanism in the primary motor cortex on the descending corticospinal tract pathways. However, this inhibition is not complete, for it is well known that the training of mental practice involves a component of the autonomic nervous system (ANS).
It has been shown that both MI and AO lead to changes in the ANS that cause excitatory sympathetic responses, although the neurophysiological bases remain uncertain and are still based on hypotheses. The functional relations between both neurocognitive processes and the sympathetic-excitatory nervous system (SNS) could be based on a preparation phase in which, the activation of the SNS, happens to a near effort and, therefore, to a close energy expenditure in physiological processes (i.e., cardiorespiratory adaptationse) which will take place in order to face said metabolic changes produced by the voluntary movement itself. In addition, several hypotheses have been described regarding the notion that the SNS not only has the quantitative objective of providing energy to the muscle effectors, but that it also qualitatively and specifically designs and adapts the parameters on demand in an attempt to save the energy provided for each precise motor execution.
Taking into account that both MI and AO cause sympathetic-excitatory changes that induce an increase in heart rate, blood pressure, respiratory rate, electrodermal activity , our hypothesis is that the combination of MI and AO induces an autonomic sympathetic-excitatory shift greater than MI does in isolation. Therefore, the main objective of this study was to compare the results obtained from intervention groups on the subject of the activation of the SNS in a program that combined MI with AO, in contrast to an isolated MI program on the one hand in asymptomatic subjects and in the other hand in patients with chronic low back pain.. The secondary objective of the present study was to explore whether there is any relationship between the sympathetic-excitatory response and the ability to generate motor imagery, the mental chronometry, and the level of physical activity.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Madrid, Spania, 28023
- CSEU La Salle
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria asymptomatic subjects:
- Age between 18 and 60
- Healthy and with no pain subjects
Inclusion Criteria patients with chronic low back pain:
- Low back pain for at least the prior 3 months
- Low back pain of nonspecific nature
- Age between 18 and 60
- Low back pain for at least 10 days per month
- Intensity of pain of between 3 and 10 on the Visual Analogue Scale
Exclusion Criteria asymptomatic subjects:
- 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.
Exclusion Criteria patients with chronic low back pain:
- 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
- Having undergone back surgery
- Specific spinal pathology
- Recent trauma
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Experimental 1
Motor Imagery
|
Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R).
|
|
Eksperimentell: Experimental 2
Action Observation
|
Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R).
Before the subjects performed the mental MI practice, they were presented with a 30 seconds video that displayed the task that they ought to imagine later.
A video was played prior to the first practice of imagination and after the second mental practice, a second video was shown.
|
|
Ingen inngripen: Kontrollgruppe
Ingen inngrep
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Electrodermal Activity
Tidsramme: Change in electrodermal activity after 5 minutes post-intervention
|
Electrodermal Activity will be measured through the use of two electrodes that recorded changes in conductance through the skin located at the back of the dominant hand
|
Change in electrodermal activity after 5 minutes post-intervention
|
|
Respiration Rate
Tidsramme: Change in respiration rate after 5 minutes post-intervention
|
Respiration Rate will be measured through a pressure transducer located in the centre of the chest, where it was fixed by a strap
|
Change in respiration rate after 5 minutes post-intervention
|
|
Heart Rate
Tidsramme: Change in heart rate after 5 minutes post-intervention
|
Heart Rate will be measured by three electrodes located in the left area of the chest.
One of the electrodes was placed in the middle zone while a second electrode was positioned on the lateral side, and a third one on the lower left side, below the first electrode.
|
Change in heart rate after 5 minutes post-intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Visuelle og kinestetiske motoriske bilder
Tidsramme: Pre-intervensjon
|
Visuell og kinestetisk motorisk bildeevne vil bli målt med MIQ-R spørreskjema.
MIQ-R har 4 bevegelser som gjentas i to underskalaer, en visuell og en kinestetisk.
I tillegg tildeles en poengsum mellom 1 og 7, hvor 1 representerer vanskeligheter med å forestille seg det motoriske bildet eller vanskeligheter med å føle bevegelsen tidligere gjort, og 7 representerer maksimal letthet.
En modifikasjon ble gjort i MIQ-R.
Punkt 2 og 5, hvor det gjøres et lite hopp, ble endret ved å stå på tå.
De interne konsistensen til MIQ-R har vært konsekvent tilstrekkelig med Cronbachs α-koeffisienter som strekker seg over 0,84 for den totale skalaen, 0,80 for den visuelle underskalaen og 0,84 for den kinestetiske underskalaen.
|
Pre-intervensjon
|
|
Mental kronometri
Tidsramme: Pre-intervensjon
|
Mental kronometrievaluering ble også brukt for å måle personens motoriske bildeevne.
Ved hjelp av en stoppeklokke ble tiden brukt for å utføre hver MIQ-R-oppgave registrert.
Registrert tid tilsvarer intervallet mellom kommandoen for å starte oppgaven, gitt av evaluatoren, og den verbale responsen på avslutningen av oppgaven, gitt av faget.
Mental kronometri er en pålitelig atferdsoppgave som tidligere har blitt brukt for å samle et objektivt mål på MI-evne
|
Pre-intervensjon
|
|
Graden av fysisk aktivitet
Tidsramme: Pre-intervensjon
|
Graden av fysisk aktivitet ble objektivisert gjennom spørreskjemaet The International Physical Activity Questionnaire, som lar forsøkspersonene deles inn i tre grupper etter deres aktivitetsnivå, som kan være høyt, moderat og lavt eller inaktivt.
|
Pre-intervensjon
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2 (Annen identifikator: Instituto Cardiovascular de Buenos Aires)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Autonome nervesystem
-
Paracelsus Medical UniversityRekruttering
-
Francois CorbinHar ikke rekruttert ennå
-
Hospices Civils de LyonFullført
-
Kaohsiung Medical University Chung-Ho Memorial...RekrutteringClinical Decision Support SystemTaiwan
-
Poitiers University HospitalFullførtSvangerskap | Endokrine system | ForebyggingsprogramFrankrike
-
Jiawei JiangRekruttering
-
Iaso Maternity Hospital, Athens, GreeceFullført
-
University of WashingtonMedical Technology Enterprise ConsortiumRekruttering
-
Changchun GeneScience Pharmaceutical Co., Ltd.FullførtFrivillig frisk | Vasomotorisk system; LabileKina
-
Sanko UniversityFullførtRyggrad | Holdning | Bekken | Stomatognatisk systemTyrkia
Kliniske studier på Motor Imagery
-
Universiti Tunku Abdul RahmanFullført
-
Centre Hospitalier Departemental VendeeFullført
-
University of ValenciaFullført
-
Istanbul UniversityFullført
-
Mälardalen UniversityDanderyd HospitalFullført
-
St. Ambrose UniversityFullført
-
Inonu UniversityRekruttering
-
Nuray AlacaRekrutteringSkulderimpingementsyndrom | SkuldersmerteTyrkia
-
Appalachian State UniversityFullført
-
Istanbul University - Cerrahpasa (IUC)FullførtSmerter, postoperativt | Albuebrudd | Problem med øvre ekstremiteter | Begrensning, MobilitetTyrkia