Virtual Reality Based Sensorimotor Speech Therapy

Broca's Aphasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928822
• Other study ID #: SANARaphasia2016/2017
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: April 2018

Study information

• Verified date: July 2018
• Source: Universitat Pompeu Fabra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Broca's Aphasia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Universitat Pompeu Fabra, Laboratory of Synthetic Perceptive, Emotive and Cognitive Systems (SPECS)	Barcelona
Spain	Clínica de l'Hospital Universatari Joan XXIII de Tarragona	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Pompeu Fabra	Hospital Universitari Joan XXIII de Tarragona.

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View 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. — View Citation

Cameirão 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. — View 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. Review. — View 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. — View Citation

Kurland J, Pulvermüller 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. — View Citation

MacGregor LJ, Difrancesco S, Pulvermüller 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. — View Citation

Pulvermüller F. Brain mechanisms linking language and action. Nat Rev Neurosci. 2005 Jul;6(7):576-82. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in linguistic performance and competence measured using abbreviated version of Boston Naming Test		Change from the baseline outcome (date of randomization) of the abbreviated version of Boston Naming Test at 16-weeks (follow up).
Secondary	The upper extremity Fugl-Meyer Assessment		Change from the baseline outcome (date of randomization) of the The upper extremity Fugl-Meyer Assessment at week 4, 8 and 16 (follow up).
Secondary	Measure of language use during daily leaving activities using Communication Activity Log		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).
Secondary	The measure of learning using Vocabulary Test		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