- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01689883
Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Study participants will be instructed to perform upper-limb movements using a system designed for upper-limb rehabilitation (Armeo Spring by Hocoma AG). The system provides subjects with unloading of the stroke-affected arm thus facilitating the performance of upper-limb movements. The system will be used to track the movements of the stroke-affected arm. Simultaneously, a custom-designed system (a prototype developed by the investigators) will be used to deliver small electrical currents to the arm. We hypothesize that the currents delivered to the arm will improve the accuracy of the movements performed by study participants.
To assess if delivering small currents to the arm has an effect on the accuracy of the movements performed by the study participants, they will receive actual stimulation for some trials and sham stimulation for other trials. Because the investigators will deliver very small currents, study participants will be unable to perceive such currents and hence tell if they are performing the movements while receiving actual or sham stimulation. By comparing trials performed while subjects receive actual stimulation with trials performed while subjects received sham stimulation, the investigators will determine if the stimulation has an effect on the accuracy of the movements performed by the subjects.
It is worth noticing that the investigators collected primary outcome data to assess changes associated with the use of actual stimulation vs sham stimulation. Data during a follow-up session was also collected, but not for the purpose of collecting outcome measures.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02129
- Spaulding Rehabilitation Hospital Boston
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- unilateral and cortical, subcortical, or cerebellar stroke
- 6 months post-stroke
- Upper extremity impairments but able to move upper extremity against gravity 25% of the range
- Ability to understand directions and follow simple instructions
- Medically stable
- Upper Extremity Fugl-Meyer between 28 and 55
- At least four (4) months since last botox treatment
- Mini-Mental State Examination (MMSE) ≥ 23
Exclusion Criteria:
- Participation in other forms of therapy/ intervention for upper extremity motor recovery
- Upper extremity or trunk fractures
- Severe fixed contractures affecting the upper limbs
- Severe perceptual deficits or visual field impairments
- Severe cognitive deficits
- Pregnant women
- Presence of an implanted electrically operated medical device
- Evidence of more than one clinical stroke
- Serious medical or neurological illness
- History of head trauma or cerebral infectious disease
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Autre: Current stimulator
The investigators have developed a device to deliver very small currents to the arm.
The device will be used while subjects perform upper-limb movements using a device for upper-limb rehabilitation.
Subjects will perform multiple trials of movement.
During half of the trials, they will receive actual stimulation.
During the other half, they will receive sham stimulation.
|
This is a device developed by the investigators to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Fugl-Meyer Assessment
Délai: Changes in Fugl-Meyer Assessment score with vs without stimulation
|
Subjects are asked to perform upper-limb movements from which a therapist can assess the severity of movement abnormalities (e.g.
flexion synergies)
|
Changes in Fugl-Meyer Assessment score with vs without stimulation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Jebsen-Taylor Hand Function Test
Délai: Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation
|
Subjects are asked to perform a set of functional movements from which a therapist can assess subjects' functional limitations
|
Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation
|
Motor Activity Log
Délai: Change in Motor Activity Log score with vs without stimulation
|
Subjects are asked about the amount and quality of use of their stroke-affected arm during the performance of daily activities
|
Change in Motor Activity Log score with vs without stimulation
|
Modified Ashworth Scale
Délai: Change in Modified Ashworth Scale score with vs without stimulation
|
A therapist examines subjects to assess the severity of spasticity
|
Change in Modified Ashworth Scale score with vs without stimulation
|
Box and Block test
Délai: Change in Box and Block test score with vs without stimulation
|
Subjects are asked to move as many small wooden blocks as possible from one to box to another in a set amount of time
|
Change in Box and Block test score with vs without stimulation
|
Grip strength
Délai: Change in grip strength with vs without stimulation
|
A hand dynamometer is used to measure grip strength
|
Change in grip strength with vs without stimulation
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
- 2011-P-001592
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Survivants d'un AVC chronique
-
PfizerComplétéLeucémie, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) PositifFrance, États-Unis, Canada, Espagne, Tchéquie, Singapour, Thaïlande, Danemark, Norvège, Corée, République de, Finlande, Hongrie, Suède, Pays-Bas, Italie, Allemagne, Ukraine, Afrique du Sud, Taïwan, Australie, Belgique, Israël, Mexique, Pologn... et plus