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Sensorimotor Control in People With and Without Neck Pain

2. september 2021 opdateret af: CEU San Pablo University

Analysis of Sensorimotor Control in People With and Without Neck Pain Using Inertial Sensor Technology: Study Protocol for a Longitudinal Prospective Observational Study

This is a descriptive, observational, longitudinal, prospective study consecutively enrolling patients with non-specific neck pain and age-matched asymptomatic participants.

The investigators will register sensorimotor control variables, including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns. These variables will be recorded by means of Inertial Measurement Unit (IMU) sensors during the following tests consecutively performed in two measuring sessions separated by 12 months: (a) kinematics of planar movements, (b) kinematics of the craniocervical flexion movement, (c) kinematics during functional tasks and (d) kinematics of task-oriented neck movements in response to visual targets.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Aitor Martin Pintado Zugasti, PhD
  • Telefonnummer: 14691 91 3724700
  • E-mail: martinpintado@ceu.es

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients will be recruited from a community sample in Madrid, Spain

Beskrivelse

Inclusion Criteria:

  • Population aged between 18 and 65 years old

Exclusion Criteria:

  • Visual impairment not corrected by the use of glasses/contact lenses
  • Migraine headache
  • Complex regional syndrome
  • Previous surgeries in the neck and/or head region
  • Sensory and/or vestibular alterations, (f) Otogenic or idiopathic vertigo/dizziness
  • Presence of tumors in the craniocervical region
  • Previous fracture in the head or neck region
  • Osseous deformities in the thoracic, cervical or cranial region

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Asymptomatic participants
Asymptomatic subjects should not present any pain in the cervical region during the last 3 months and no previous treatment for neck pain in order to be included in the study.
Diagnostisk test: sensorimotor control analysis using inertial sensor technology
Inertial Measurement Unit (IMU) sensors will measure sensorimotor control variables including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns
Neck pain patients
Patients with neck pain should have an intensity of pain of at least 3 points out of 10 on a Visual Analog Scale and a neck pain duration of at least 3 months of evolution. Neck pain could be from nonspecific mechanical origin, associated with whiplash or with a previous medical diagnosis of degenerative or inflammatory alterations of the cervical spine, associated or not with headache and pain in the shoulder region or the upper limb.
Diagnostisk test: sensorimotor control analysis using inertial sensor technology
Inertial Measurement Unit (IMU) sensors will measure sensorimotor control variables including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Active range of motion
Tidsramme: 1 year
Expressed as an angular displacement (°) in 3 full-movements (flexion-extension, lateral flexion and rotation)
1 year
Movement speed
Tidsramme: 1 year
Expressed as angular velocity (°/sec) in 3 full-movements (flexion-extension, lateral flexion and rotation)
1 year
Smoothness of motion
Tidsramme: 1 year
expressed as movement jerk (º/sec3)
1 year
Head repositioning accuracy
Tidsramme: 1 year
Calculated as the repositioning error considering the difference between the neutral starting position and the following positions reached after the performance of any of the movements
1 year
Motion coupling patterns
Tidsramme: 1 year
Calculated as the angular displacement occurring in a different anatomical plane to the one that is being tested for each of the planar movements
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical activity level
Tidsramme: 1 year
Measured using the short version of the International Physical Activity Questionnaire (IPAQ). The score of the scale is expressed in MET level x minutes of activity/day x days per week. Levels of 3.3 METs are considered light, 4.0 METs are moderate and 8.0 METs are vigorous.
1 year
Fear of movement and injury
Tidsramme: 1 year
Measured using the Tampa Scale for Kinesiophobia (TSK-11). It consists of 11 questions scored from 1 to 4. Therefore, a score of 11 is the lowest possible level of kinesiphobia, while 44 is the highest.
1 year
Pain-related fear-avoidance
Tidsramme: 1 year
Measured using the Fear Avoidance Components Scale (FACS). It has 20 itemsmeasured on a 6-point Likert scale for total possible score of 100 and the lowest possible score of 0. Higher scores indicate higher levels of fear avoidance.
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

CEU San Pablo University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

10. oktober 2021

Primær færdiggørelse (Forventet)

15. februar 2022

Studieafslutning (Forventet)

15. februar 2023

Datoer for studieregistrering

Først indsendt

31. august 2021

Først indsendt, der opfyldte QC-kriterier

31. august 2021

Først opslået (Faktiske)

2. september 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CEU-023

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Placeringer

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