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Virtual Reality Based Sensorimotor Speech Therapy

Primary Purpose

Broca's Aphasia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
VR-based sensorimotor aphasia therapy
Control Group (conventional aphasia rehabilitation)
Sponsored by
Universitat Pompeu Fabra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Broca's Aphasia focused on measuring stroke, broca's aphasia, priming, Intensive language-action therapy, Rehabilitation gaming system

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Virtual reality based sensorimotor aphasia therapy.

Conventional aphasia therapy.

Outcomes

Primary Outcome Measures

Change in linguistic performance and competence measured using abbreviated version of Boston Naming Test

Secondary Outcome Measures

The upper extremity Fugl-Meyer Assessment
Measure of language use during daily leaving activities using Communication Activity Log
The measure of learning using Vocabulary Test

Full Information

First Posted
July 30, 2016
Last Updated
July 11, 2018
Sponsor
Universitat Pompeu Fabra
Collaborators
Hospital Universitari Joan XXIII de Tarragona.
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1. Study Identification

Unique Protocol Identification Number
NCT02928822
Brief Title
Virtual Reality Based Sensorimotor Speech Therapy
Official Title
Terapia de Lenguaje, Sensorial y Motora, Basada en Realidad Virtual
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Pompeu Fabra
Collaborators
Hospital Universitari Joan XXIII de Tarragona.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Broca's Aphasia
Keywords
stroke, broca's aphasia, priming, Intensive language-action therapy, Rehabilitation gaming system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Virtual reality based sensorimotor aphasia therapy.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Conventional aphasia therapy.
Intervention Type
Behavioral
Intervention Name(s)
VR-based sensorimotor aphasia therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group (conventional aphasia rehabilitation)
Intervention Description
8 weeks, 1 session a week, 30min-1h per session of conventional aphasia rehabilitation training the same vocabulary as the experimental group.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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).
Title
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).
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Maria San Segundo Mozo, Dra.
Organizational Affiliation
Laboratory of Synthetic Perceptive, Emotive and Cognitive Systems
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosa Maria San Segundo Mmozo, Dra.
Organizational Affiliation
Servicio de Medicina Fisica i Rehabilitacion de Joan XXII de Tarragona. 977295801
Official's Role
Study Director
Facility Information:
Facility Name
Universitat Pompeu Fabra, Laboratory of Synthetic Perceptive, Emotive and Cognitive Systems (SPECS)
City
Barcelona
ZIP/Postal Code
08018
Country
Spain
Facility Name
Clínica de l'Hospital Universatari Joan XXIII de Tarragona
City
Tarragona
ZIP/Postal Code
43005
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22414990
Citation
Carter AR, Shulman GL, Corbetta M. Why use a connectivity-based approach to study stroke and recovery of function? Neuroimage. 2012 Oct 1;62(4):2271-80. doi: 10.1016/j.neuroimage.2012.02.070. Epub 2012 Mar 5.
Results Reference
background
PubMed Identifier
25403745
Citation
MacGregor LJ, Difrancesco S, Pulvermuller F, Shtyrov Y, Mohr B. Ultra-rapid access to words in chronic aphasia: the effects of intensive language action therapy (ILAT). Brain Topogr. 2015 Mar;28(2):279-91. doi: 10.1007/s10548-014-0398-y. Epub 2014 Nov 18.
Results Reference
background
PubMed Identifier
15959465
Citation
Pulvermuller F. Brain mechanisms linking language and action. Nat Rev Neurosci. 2005 Jul;6(7):576-82. doi: 10.1038/nrn1706.
Results Reference
background
PubMed Identifier
22294409
Citation
Kurland J, Pulvermuller F, Silva N, Burke K, Andrianopoulos M. Constrained versus unconstrained intensive language therapy in two individuals with chronic, moderate-to-severe aphasia and apraxia of speech: behavioral and fMRI outcomes. Am J Speech Lang Pathol. 2012 May;21(2):S65-87. doi: 10.1044/1058-0360(2012/11-0113). Epub 2012 Jan 31.
Results Reference
background
PubMed Identifier
15458061
Citation
Boian R, Sharma A, Han C, Merians A, Burdea G, Adamovich S, Recce M, Tremaine M, Poizner H. Virtual reality-based post-stroke hand rehabilitation. Stud Health Technol Inform. 2002;85:64-70.
Results Reference
background
PubMed Identifier
20860808
Citation
Cameirao MS, Badia SB, Oller ED, Verschure PF. Neurorehabilitation using the virtual reality based Rehabilitation Gaming System: methodology, design, psychometrics, usability and validation. J Neuroeng Rehabil. 2010 Sep 22;7:48. doi: 10.1186/1743-0003-7-48.
Results Reference
background
PubMed Identifier
11561668
Citation
Jack D, Boian R, Merians AS, Tremaine M, Burdea GC, Adamovich SV, Recce M, Poizner H. Virtual reality-enhanced stroke rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2001 Sep;9(3):308-18. doi: 10.1109/7333.948460.
Results Reference
background
PubMed Identifier
20508185
Citation
Saposnik G, Teasell R, Mamdani M, Hall J, McIlroy W, Cheung D, Thorpe KE, Cohen LG, Bayley M; Stroke Outcome Research Canada (SORCan) Working Group. Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle. Stroke. 2010 Jul;41(7):1477-84. doi: 10.1161/STROKEAHA.110.584979. Epub 2010 May 27.
Results Reference
background
PubMed Identifier
25638465
Citation
Routhier S, Bier N, Macoir J. The contrast between cueing and/or observation in therapy for verb retrieval in post-stroke aphasia. J Commun Disord. 2015 Mar-Apr;54:43-55. doi: 10.1016/j.jcomdis.2015.01.003. Epub 2015 Jan 21.
Results Reference
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PubMed Identifier
25688082
Citation
Abel S, Weiller C, Huber W, Willmes K, Specht K. Therapy-induced brain reorganization patterns in aphasia. Brain. 2015 Apr;138(Pt 4):1097-112. doi: 10.1093/brain/awv022. Epub 2015 Feb 15.
Results Reference
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PubMed Identifier
32907594
Citation
Grechuta K, Rubio Ballester B, Espin Munne R, Usabiaga Bernal T, Molina Hervas B, Mohr B, Pulvermuller F, San Segundo RM, Verschure PFMJ. Multisensory cueing facilitates naming in aphasia. J Neuroeng Rehabil. 2020 Sep 9;17(1):122. doi: 10.1186/s12984-020-00751-w.
Results Reference
derived
PubMed Identifier
30913976
Citation
Grechuta K, Rubio Ballester B, Espin Munne R, Usabiaga Bernal T, Molina Hervas B, Mohr B, Pulvermuller F, San Segundo R, Verschure P. Augmented Dyadic Therapy Boosts Recovery of Language Function in Patients With Nonfluent Aphasia. Stroke. 2019 May;50(5):1270-1274. doi: 10.1161/STROKEAHA.118.023729.
Results Reference
derived

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Virtual Reality Based Sensorimotor Speech Therapy

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