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- Registre américain des essais cliniques
- Essai clinique NCT04325516
Decoding Motion Planning Using Cortical Potentials
Decoding Motion Planning Using Cortical Potentials in People With a Transfemoral Amputation and Able-bodied Individuals
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The evolution of lower limb prostheses has made considerable progress in the past decades. There has been a transition from passive (e.g. Total knee®, Össur) to quasi-passive (e.g. C-leg®, Otto Bock) and eventually to active prostheses (e.g. Power knee®, Össur). The development always focused on an amputation as a primary peripheral disorder. For example, manufacturers have been searching to compensate the loss of muscle mass by adding torque into the prosthesis. However, few considerations have yet been taken to the fact that central adaptations are also observed after amputation in terms of neuroplasticity and reorganization.
The atypical motion planning strategies of people with a lower limb amputation (LLA) could possibly be related to the challenges that they experience during daily activities, such as the sit to stand transfer. Standing up from a chair is a relevant clinical problem and current devices do not yet relieve the asymmetrical loading. A few studies have already investigated the muscular activity during a sit to stand movement in people with a LLA and able-bodied individuals. The movement is characterized by a forward displacement of the centre of mass with the highest activation of the m. gluteus maximus, m. adductor magnus and m. biceps femoris.The sit to stand transfer is a potential movement to investigate brain activity incorporating the advantages and disadvantages of EEG measurements.
Until now, the development of lower limb prostheses approaches people with a LLA as a peripheral disorder whereas relevant central adaptations are also observed. Therefore, the purpose of this study is to identify the cortical activity that is responsible for successfully completing a sit to stand transfer. The hypothesis is that different brain locations are activated in people with a transfemoral amputation for motion planning compared to able-bodied individuals.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Brussel, Belgique, 1050
- Recrutement
- Vrije Universiteit Brussel
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Contact:
- Jo Ghillebert, msc
- Numéro de téléphone: 0494902770
- E-mail: jo.ghillebert@vub.be
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age: 25 - 75 years
- Gender: men and women
- Level of amputation: unilateral transfemoral
- Vascular or traumatic cause of amputation
- Medicare Functional Classification Level25: K3-4
- Participants are able to stand up from a chair and return to the seated position without support of their hands for ten repetitions
- Participants wear their prosthesis for at least 8 hours/day (Prosthetic use has been shown to have an influence on functional reorganization)
- No cognitive impairment. This will be objectified with the mini-mental state examination (score on 30)
Exclusion Criteria:
- Any neurological disease
- No upper limb or bilateral amputation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: People with a lower limb amputation
Participants will perform four tasks in a randomized order:
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Participants will perform four tasks in a randomized order:
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Expérimental: Able bodied individuals
Participants will perform four tasks in a randomized order:
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Participants will perform four tasks in a randomized order:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
ElectroEncephalography in milliseconds
Délai: Approximatley 9 months
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Movement related cortical potential before the actual movement
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Approximatley 9 months
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ElectroMyography activity in milliseconds
Délai: Approximatley 9 months
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Amplitude
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Approximatley 9 months
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ElectroMyography timing
Délai: Approximatley 9 months
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Time of movement onset
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Approximatley 9 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Duration of the sit to stand test
Délai: Approximatley 9 months
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Duration of the sit to stand test
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Approximatley 9 months
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Autres numéros d'identification d'étude
- EEGstudy
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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