tDCS and Robotic Therapy in Stroke
After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.
The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Ferrara, Italie
- Ferrara University Hospital
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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:
- Males and females subjects. Age > 18 years.
- Diagnosis of first ischemic stroke
- Impairment of the upper limb
- Trunk control defined in the Trunk-Control Test (TCT), with a score > 50.
Exclusion Criteria:
- anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
- Impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
- contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
- Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
- Neurological or psychiatric pathology
- severe cardio-pulmonary, renal, hepatic diseases
- Pregnancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur factice: sham-tDCS + UE robot-assisted therapy
This group will receive the same robot-assisted therapy of the intervention group, in association of sham-tDCS.
This consists in a 30 seconds stimulation, with the same instrumentation and electrodes placement.
This method of sham stimulation was previously validated.
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Expérimental: real-tDCS + UE robot-assisted therapy
This group will receive continuous stimulation lasting 30 minutes during the session of robot-assisted therapy. The training session, which includes multiplanar, repetitive and target reaching movements, will be given 5 times a week for 2 weeks(REO Therapy System; Motorika, Medical LTD, Israel). Each session will last about 30 minutes. Transcranial direct current stimulation (tDCS) will be administered as follows. The anode will be placed on the primary motor cortex (M1) of the affected hemisphere and the cathode on the contralateral M1 area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries (Brainstim, EMS, Italy). This continuous stimulation lasted 30 minutes, with an intensity of 1mA. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fugl-Meyer Upper Extremity
Délai: A week prior to treatment beginning
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Measure of upper extremity motor impairment.
The upper extremity score ranges from 0-66.
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A week prior to treatment beginning
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Box and Block Test
Délai: A week prior to treatment beginning
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Test for gross motor function.
It counts the number of blocks that can be transported from one compartment of a box to another compartment within 1 minute.
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A week prior to treatment beginning
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Ashworth Modified Scale
Délai: A week prior to treatment beginning
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a 6 point measure of spasticity.
We will assess the spasticity at the shoulder, elbow and, wrist
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A week prior to treatment beginning
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Motor Activity Log (MAL)
Délai: A week prior to treatment beginning
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Assessment of the change in real-world arm use in activities of daily living.
Subjects are asked to score the quality of movement as well as amount of use of the affected arm in a number of common daily activities.
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A week prior to treatment beginning
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Assessment of cortical excitability (TMS)
Délai: A week prior to treatment beginning
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MEP of upper limb muscles (first dorsal interosseous) will be recorded with surface EMG electrodes. neurophysiological parameters analyzed:
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A week prior to treatment beginning
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
- Stroke_tDCS
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