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L'essai clinique NCT06547073 (VR4shoulder) pour Épaule gelée est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Université de GandThe Effect of Virtual Reality Training Compared to Traditional Exercise in Patients With Frozen Shoulder (VR4shoulder) 45 Randomisé Exercice Virtuel
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT06547073 (VR4shoulder) est une étude interventionnel pour Épaule gelée. Son statut actuel est : en recrutement. L'étude a débuté le 8 avril 2024 et vise à recruter 45 participants. Dirigée par l'Université de Gand, l'étude devrait être terminée d'ici le 31 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 9 août 2024.
Résumé succinct
Background: Virtual reality (VR) technology sees a rising appearance in clinical settings, and can be used for physical rehabilitation of the shoulder joint. The immersive virtual world created by VR games can be a distraction of the limitations and hindrances a patient experiences when exercising. Frozen shoulder (FS) or adhesive capsulitis is one of such instances of shoulder pathologies where pain and limited rang...Afficher plus
Titre officiel
Exploring the Possibilities of Virtual Reality in Rehabilitation of Patients With Frozen Shoulder
Pathologies
Épaule geléeAutres identifiants de l'étude
- VR4shoulder
- ONZ-2023-0381
Numéro NCT
Date de début (réel)
2024-04-08
Dernière mise à jour publiée
2024-08-09
Date de fin (estimée)
2025-12-31
Inscription (estimée)
45
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Objectif principal
Traitement
Méthode d'allocation
Non randomisé
Modèle d'intervention
Étude croisée
Masquage
Double aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalFrozen shoulder group Patient group | Virtual reality exercise training Beat saber Traditional exercise training Bench slides, supine active assisted flexion, pendulum exercise, seated active assisted external rotation |
Comparateur actifHealthy group Healthy subjects without shoulder pain | Virtual reality exercise training Beat saber |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
3D upper limb kinematics | Noraxon IMU | During VR session (both groups) - Day 1 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Shoulder range of motion | Goniometer | Immediately before and after both interventions (patients group) - Day 1 |
Shoulder strength | Hand held dynamometer | Immediately before and after both interventions (patients group) - Day 1 |
Shoulder pain | VAS | Immediately before and after both interventions (patients group) - Day 1 |
Personal experience with VR session | Interview | Immediately before and after both interventions (patients group) - Day 1 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
A diagnosis of frozen shoulder/adhesive capsulitis (by a medical doctor) both idiopathic and postoperative/posttraumatic
The participants need to have:
- a passive ROM restriction (measured using goniometry) at the affected shoulder of 25% or more in at least two directions in comparison to the unaffected shoulder
- an external rotation restriction at the affected shoulder of at least 50% when compared to the unaffected side
- pain and restricted ROM present for at least two months, reaching a plateau or becoming worse
- gradual onset of pain and stiffness
The participants are allowed to already be in therapy with a physiotherapist and do not have to stop an ongoing therapy in order to participate in the study. The reason for this is that only the short-term effect is being researched
The participants are allowed to have had an operative treatment if they still have the aforementioned restrictions
- The presence of contra-indications to perform active shoulder movements
- The presence of neurological conditions
- Systemic disease (e.g. Fibromyalgia, rheumatism, muscle disease…)
- The presence of visual conditions that will not allow performing VR therapy without losing balance
- A pathology of the back of lower limbs which do not allow the performance of exercise in standing position
- A higher risk of falling with at least one fall during the past year
- Insufficient control of the Dutch language
HEALTHY GROUP Exclusion criteria
- shoulder pain in the last 6 months
- prior shoulder surgery
- fractures of the upper arm or scapula
- systemic disease (e.g. Fibromyalgia, rheumatism, muscle disease…)
- the presence of contra-indications to perform active shoulder movements (e.g. recent elbow surgery), balance disorders (e.g. benign paroxysmal positional vertigo), visual disorders (e.g. severe reduced vision or visual acuity)
- any pathology in the back/lower limbs that prevents standing exercises from being performed
- increased risk of falls with at least one fall incident in the past year
- insufficient knowledge of the Dutch language.
Université de Gand282 essais cliniques actifs à explorerContact central de l'étude
Contact: Annelies Maenhout, PhD, 0032473806159, [email protected]
1 Centres de l'étude dans 1 pays
Ghent University, Ghent, 9000, Belgium
Annelies Maenhout, PhD, Contact, 0032473806159, [email protected]
En recrutement