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| Name | Class |
|---|---|
| Neuroelectrics Corporation | INDUSTRY |
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Stroke represents one of the main causes of adult disability and will be one of the main contributors to the burden of disease in 2030. However, our healthcare systems do not have enough resources to cover the current demand let alone its future increase. There is a need to deploy new approaches that advance the current rehabilitation methods and enhance their efficiency.
One of the latest approaches used for the rehabilitation of a wide range of deficits of the nervous system is based on virtual reality (VR) applications, which combine training scenarios with dedicated interface devices. On the other hand, recent studies have shown the potential of transcranial direct current stimulation (tDCS) to restore motor function in hemiparetic stroke patients. It must be emphasized, however, that so far little work exists on the quantitative assessment of the clinical impact of VR based approaches in combination with tDCS protocols. We hypothesize that the combination of VR-based motor rehabilitation protocols with concurrent anodal tDCS can boost functional recovery, and may achieve superior effects when compared to 3 alternative treatments: 1) VR without tDCS, 2) occupational therapy with tDCS, and 3) occupational therapy without tDCS.
The findings derived from this study will contribute to establish a novel and superior neurorehabilitation paradigm that can accelerates the recovery of hemiparetic stroke patients. Besides the clinical impact, such achievement could have relevant socioeconomic impact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-based motor rehabilitation with tDCS | Experimental |
| |
| Occupational Therapy with tDCS | Active Comparator |
| |
| VR-based motor rehabilitation with sham tDCS | Sham Comparator |
| |
| Occupational Therapy with sham tDCS | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality-based therapy for upper-limbs motor rehabilitation | Behavioral | During each session, the subject will perform 4 VR-based exercises that involve reaching, grasping, and intercepting virtual objects. The training will last a total of 30 min per session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of arm/hand function as captured by the upper extremity Fugl-Meyer assessment scale | At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Independence as captured by Barthel scale | At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up) | |
| Change of motor function in ADLs as captured by Chedoke Arm and Hand Activity Inventory (CAHAI) scale | At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Verschure, Prof. | Contact | 0034935422202 | paul.verschure@upf.edu | |
| Belén Rubio, PhD | Contact | 0034935422202 | belen.rubio@upf.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unitat de Rehabilitació de l'Hospital Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
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| Anodal transcranial direct-current stimulation (tDCS) | Device | Concurrent anodal tDCS on sensorimotor cortex on the ipsilesional hemisphere. |
|
| Occupational Therapy for upper-limbs motor rehabilitation | Behavioral | During each session, the subject will perform 4 occupational therapy exercises that involve reaching, grasping, and intercepting objects. The training will last a total of 30 min per session. |
|
| Sham transcranial direct-current stimulation (tDCS) | Device | Concurrent sham tDCS on sensorimotor cortex on the ipsilesional hemisphere. |
|
| Change of interhemispheric balance as captured by EEG recordings | At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up) |
| Change of spasticity in proximal and distal muscles as captured by Ashworth scale | At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up) |
| Change of spatial hemineglect as captured by the Star cancellation test | At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up) |
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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