Virtual Reality Based Sensorimotor Speech Therapy
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|ClinicalTrials.gov Identifier: NCT02928822|
Recruitment Status : Completed
First Posted : October 10, 2016
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Broca's Aphasia||Behavioral: VR-based sensorimotor aphasia therapy Behavioral: Control Group (conventional aphasia rehabilitation)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Terapia de Lenguaje, Sensorial y Motora, Basada en Realidad Virtual|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||April 2018|
Experimental: Experimental Group
Virtual reality based sensorimotor aphasia therapy.
Behavioral: VR-based sensorimotor aphasia therapy
VR-based sensorimotor aphasia therapy. 8 weeks, 1 session a week, 30min-1h per session of language and motor therapy using using VR rehabilitation gaming system. The patients will play in pairs.
Active Comparator: Control Group
Conventional aphasia therapy.
Behavioral: Control Group (conventional aphasia rehabilitation)
8 weeks, 1 session a week, 30min-1h per session of conventional aphasia rehabilitation training the same vocabulary as the experimental group.
- Change in linguistic performance and competence measured using abbreviated version of Boston Naming Test [ Time Frame: Change from the baseline outcome (date of randomization) of the abbreviated version of Boston Naming Test at 16-weeks (follow up). ]
- The upper extremity Fugl-Meyer Assessment [ Time Frame: Change from the baseline outcome (date of randomization) of the The upper extremity Fugl-Meyer Assessment at week 4, 8 and 16 (follow up). ]
- Measure of language use during daily leaving activities using Communication Activity Log [ Time Frame: Change from the baseline outcome (date of randomization) of the Communication Activity Log assesed by the patient, a blinded therapist and a caregiver at week 4, 8 and 16 (follow up). ]
- The measure of learning using Vocabulary Test [ Time Frame: Measured five times over the period of the intervention (at randomization, at week 2, at week 4, at week 6, at week 8) and once at the followed up period at week 16 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928822
|Universitat Pompeu Fabra, Laboratory of Synthetic Perceptive, Emotive and Cognitive Systems (SPECS)|
|Barcelona, Spain, 08018|
|Clínica de l'Hospital Universatari Joan XXIII de Tarragona|
|Tarragona, Spain, 43005|
|Principal Investigator:||Rosa Maria San Segundo Mozo, Dra.||Laboratory of Synthetic Perceptive, Emotive and Cognitive Systems|
|Study Director:||Rosa Maria San Segundo Mmozo, Dra.||Servicio de Medicina Fisica i Rehabilitacion de Joan XXII de Tarragona. 977295801|