Stroke Clinical Trial
Official title:
Efficacy of an Attentional Process Training Using Competitive Versus Non Competitive Strategies
Verified date | August 2015 |
Source | Hospitales Nisa |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Interventional |
Within a prospective, randomised, controlled study 60, selected patients with chronic (> 6 months) stroke or traumatic brain injury will be randomised to 30 1-hour sessions of competitive versus non-competitive attentional training. Competitive training will include fifteen 1-hour sessions of standard (paper and pencil) training under competitive situations and fifteen 1-hour sessions of competitive attentional games designed for this purpose using a new virtual reality system (conventional liquid-crystal-display screen with an infrared LED array to facilitate multi-touch experience embedded in a conventional table). Progress will be evaluated by pre and post measurement of attentional neuropsychological tests, subjective reports of global attention, usability and motivational scales. Our hypothesis is that competitive training is more effective in improving attention than conventional training in the chronic phase after acquired brain injury.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Acquired brain injury patients (stroke and traumatic brain injury) - Chronicity > 6 months - More than 3 months under cognitive rehabilitation - Mississippi Aphasia Screening Test (comprehension subtest > 45) Exclusion Criteria: - Severe cognitive impairment defined as < 23 on Mini Mental Status Examination - Unable to give informed consent - Visual or auditive disorders limiting the ability to comply with treatment regimen |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospitales NISA | Valencia |
Lead Sponsor | Collaborator |
---|---|
Hospitales Nisa | Universidad Politécnica de Valencia, University of Seville |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Family-centered outcomes | Moos Attention Rating Scale, Subjective perception of improvement | Baseline versus end of treatment (an expected average of 8 weeks) | No |
Primary | Change in attentional psychometric measures | Neuropsychological battery: Conner's Continuous Performance Test (CPT-II), Color-Trail Test, d2, Stroop test, Wechsler Adult Intelligence Scale-IV digit-span, Corsi block-tapping test | Baseline versus end of treatment (an expected average of 8 weeks) | No |
Secondary | Usability measures | System Usability Scale, Intrinsic Motivation Inventory | Baseline versus end of treatment (an expected average of 8 weeks) | No |
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