Virtual Reality Based Sensorimotor Speech Therapy

July 11, 2018 updated by: Paul Verschure, Universitat Pompeu Fabra

Terapia de Lenguaje, Sensorial y Motora, Basada en Realidad Virtual

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08018
        • Universitat Pompeu Fabra, Laboratory of Synthetic Perceptive, Emotive and Cognitive Systems (SPECS)
      • Tarragona, Spain, 43005
        • Clínica de l'Hospital Universatari Joan XXIII de Tarragona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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).
Change from the baseline outcome (date of randomization) of the abbreviated version of Boston Naming Test at 16-weeks (follow up).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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).
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).
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitat Pompeu Fabra

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Universitari Joan XXIII de Tarragona.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SANARaphasia2016/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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