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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
Sponsor:
Collaborator:
Hospital Universitari Joan XXIII de Tarragona.
Information provided by (Responsible Party):
Paul Verschure, Universitat Pompeu Fabra

Brief Summary:
The purpose of this study is to determine whether VR based language rehabilitation scenario based on the core premises of ILAT has a beneficial effect on the linguistic performance (faster retrieval of the target lexicon and general fluency) of Broca's aphasia patients. Furthermore, it aims at testing the effects of cueing (visual and auditory) on word retrieval.

Condition or disease Intervention/treatment Phase
Broca's Aphasia Behavioral: VR-based sensorimotor aphasia therapy Behavioral: Control Group (conventional aphasia rehabilitation) Not Applicable

Detailed Description:
Acquired brain lesions such as stroke often result the most common disabling neurological damages (Carter et al, 2012). 35-40% of stroke patients suffer serious language deficits and patients are frequently left with chronic disabilities which adversely impact their quality of life. Thus, the need for efficient rehabilitation methods increases. Recent studies show that Broca's area and the premotor cortex are anatomically coupled (Pulvermuller 2005) suggesting that for a therapy to be effective, in the brain there must be an interaction between linguistic neural system, motor and sensory circuits, memory, planning and monitoring (Kurland et al, 2012). These hypotheses led to the establishment of the so-called Intensive Language-Action Therapy (ILAT) (Pulvermuller 2012) which promotes motor movement during language practice. Thus, ILAT is an action-embedded language therapy grounded in three main principles: intense practice, overcoming learned non-use, and promoting motor actions (no compensations). Recently, a number of studies examined the functionality of virtual reality based rehabilitation systems that aim at post stroke motor recovery of upper extremities (Boian et al., 2002; Cameirão, Badia, Oller, & Verschure, 2010; Jack et al., 2001; Saposnik et al., 2010). In the present study, the goal is to further validate VR based language rehabilitation system based on the core principles of ILAT implemented within the environment of the rehabilitation Gaming System (RGS). Additionally, the goal is to investigate the effects of cueing on word retrieval. It was shown that conduction and Broca's aphasics exhibit the highest responsiveness to cueing (Li & Williams 1989). In order to overcome subsequent disturbances in word retrieval mechanisms, a number of cueing methods have been established to improve both the immediate and long term lexical access (Howard 2000). Both semantic and phonemic cues act as primes and are usually administered by the therapist in a written or oral manner containing phonological, semantic or syntactic information about the target word (Howard et al. 1985, Howard2000). Here, the investigators will implement the system with videos representing the lip motion representative for a correct pronunciation of the target words, as well as a representative sound (i.e. barking sound in case of dog). The investigators expect that the proposed system will be efficient in treating post stroke chronic Broca's aphasia patients according to the standard scales such as Boston Naming Test and Communicative Activity Log.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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). ]

Secondary Outcome Measures :
  1. 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). ]
  2. 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). ]
  3. 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 ]


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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Broca's aphasia patient following ischemic and hemorrhagic strokes (moderate and chronic stages).
  • Mild, moderate and chronic Broca's stages.
  • Age: between 25 and 85 years old.
  • Absence of any major cognitive impairments (MMSE>25).

Exclusion Criteria:

  • Presence of major perceptual, motor and neuropsychological impairments that make it difficult to interact with the system, including severe forms of motor impairments and apraxia, visual processing deficits, planning deficits, learning deficits, memory deficits, or attentional deficits.

Information from the National Library of Medicine

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


Locations
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Spain
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
Sponsors and Collaborators
Universitat Pompeu Fabra
Hospital Universitari Joan XXIII de Tarragona.
Investigators
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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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paul Verschure, Professor, Universitat Pompeu Fabra
ClinicalTrials.gov Identifier: NCT02928822     History of Changes
Other Study ID Numbers: SANARaphasia2016/2017
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Paul Verschure, Universitat Pompeu Fabra:
stroke
broca's aphasia
priming
Intensive language-action therapy
Rehabilitation gaming system

Additional relevant MeSH terms:
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Aphasia
Aphasia, Broca
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms