- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05032911
Sensorimotor Control in People With and Without Neck Pain
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Aitor Martin Pintado Zugasti, PhD
- Numéro de téléphone: 14691 91 3724700
- E-mail: martinpintado@ceu.es
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
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.
|
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.
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Active range of motion
Délai: 1 year
|
Expressed as an angular displacement (°) in 3 full-movements (flexion-extension, lateral flexion and rotation)
|
1 year
|
Movement speed
Délai: 1 year
|
Expressed as angular velocity (°/sec) in 3 full-movements (flexion-extension, lateral flexion and rotation)
|
1 year
|
Smoothness of motion
Délai: 1 year
|
expressed as movement jerk (º/sec3)
|
1 year
|
Head repositioning accuracy
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Physical activity level
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CEU-023
Informations sur les médicaments et les dispositifs, documents d'étude
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