Aphasia, BrocaRNAATNCT05274360
Remote Neurobased Approach to Aphasia Therapy
A study testing Mobile evidence-based aphasia therapy and Conventional aphasia rehabilitation in people with Aphasia, Broca and Aphasia, Wernicke, run by Institute for Bioengineering of Catalonia at 1 site in Spain.
Trial summary
The purpose of this study is the development and validation of an evidence-based mobile application, based on the core premises of Intensive Language-Action Therapy (ILAT) for aphasia, for the training and improvement of chronic aphasia patients administered at the patient's home. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aphasia, Broca, Aphasia, Wernicke, Aphasia, Fluent
- What is being tested?
- Mobile evidence-based aphasia therapy and Conventional aphasia rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 29 Nov 2021to 29 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with any type of aphasia
- 6 or more months have passed since the stroke (chronic stage)
- Age between 18 and 90 years
Who cannot join
- Non-compliance with some of the inclusion criteria
- Presence of major perceptual, cognitive, motor, cognitive or neuropsychological pathology that can interfere with aphasia or 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
- Inability to understand the study participation
- Patients with an Android phone or tablet
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institute for Bioengineering of Catalonia - Specs Lab
Barcelona, 08930
About this study
Official title: Neuroscience-Based Aphasia Therapy Adapted to Remote, Mobile-Based Treatment
The purpose of this study is the development and validation of an evidence-based mobile application, based on the core premises of Intensive Language-Action Therapy (ILAT) for aphasia, for the training and improvement of chronic aphasia patients administered at the patient's home. It aims at testing the beneficial effect on the linguistic performance (as assessed by the Barcelona and CAL clinical tests) counteracting learned non-use and the usability of the application as a tool for training once discharged from hospital care.
Read the detailed description
Acquired brain lesions such as stroke often result in the most common disabling neurological damages. Up to 42% of stroke patients suffer serious language deficits and patients are frequently left with chronic disabilities which adversely impact their quality of life. One of the main challenges in aphasia rehabilitation includes long-term effects. After a certain time (i.e., 3-6mo, chronic phase), the frequency of therapy will decrease or stop, even if the patient has not always reached the expected or desired level of recovery. After this, a body of evidence suggests that the person with aphasia might decrease the use of verbal language given the negative reinforcement when trying to use the deteriorated function and failing to achieve a successful communication. This might lead to relying on other forms of communication (e.g., gestures) and to a vicious cycle of deterioration of verbal skills known as Learned Non-Use principle. Together with the pandemic socioeconomic situation and limited resources at healthcare facilities, this calls for the need of effective and efficient interventions that can be deployed at the house of the patients, in the form of auto-administered therapy. Despite the limited exploration of portable technologies in aphasia recovery, their use has been extensive and successful in other domains such as motor rehabilitation. Importantly, patients with aphasia report that the number 1 topic they would like to know more about is how to keep recovering after therapy ends.
Following recent evidence on experience-dependent plasticity mechanisms for successful stroke recovery and well-established theory-grounded interventions, such as ILAT, the present study aims to study the usability and improvement potential of a mobile-based aphasia rehabilitation app for stroke patients, used at home. A previous collaboration between both centers (SPECS lab and Hospital Joan XIII) used a computer-based setup. In this study by Grechuta et al. (2019), the Rehabilitation Gaming System for aphasia (RGSa) shows positive significant results on language (P= 0.001) and communication (P<0.05) compared to conventional therapy in the long term (16 weeks). This study will assess the usability, risks, and clinical outcome of the same principles applied to a mobile application that is prescribed to be used at home for two twenty-minutes session per day during two weeks.
- Conditions
- Aphasia, Broca, Aphasia, Wernicke, Aphasia, Fluent, Aphasia, Nonfluent, Aphasia
- Being tested
- Mobile evidence-based aphasia therapy, Conventional aphasia rehabilitation
- Medical subject headings
- Aphasia, Broca, Aphasia, Wernicke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile evidence-based aphasia therapyBehavioural
Use of mobile application to practice language for 2 weeks with a recommendation of 2 sessions per day of 20 minutes. The Android application, which is a Unity-based 2D game, will be installed on the patient's own phone, and they will play individually with the support of a family member if needed. The patients are free to start and stop using the application at any time. The application is safe to use, and it consists of therapeutic training methods such as object-matching, word search, writing, and manual voice recordings.
Conventional aphasia rehabilitationBehavioural
Control Group (conventional aphasia rehabilitation). No therapy as patients are in the chronic stage, where they do not receive healthcare rehabilitation training.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Mobile evidence-based aphasia therapy Receives: Behavioral: Mobile evidence-based aphasia therapy |
| Control Group | Active comparator | Conventional aphasia therapy Receives: Behavioral: Conventional aphasia rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-group changes of language function
Clinical scale for language (Barcelona Test) will be assessed at baseline T0 (prior to the use of the application) and T1 (after two weeks of use) for the experimental group.
Scale from 0 (minimum) to 365 (maximum) where higher scores indicate a better outcome.
Measured: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
Within-group changes of communication
Clinical scale for communication (Communicative Activity Log; Pulvermüller et al., 2001b) will be assessed at baseline T0 (prior to the use of the application) and T1 (after two weeks of use) for the experimental group.
Scale from 0 (minimum) to 5 (maximum) where higher scores indicate a better outcome.
Measured: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
Secondary outcomes (9)
Between-group change of language function
Clinical scale for language (Barcelona Test) will be assessed at baseline T0 (time 0) and T1 (time 1).
Scale from 0 (minimum) to 365 (maximum) where higher scores indicate a better outcome.
Measured: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
Between-group change of communication
Clinical scale for communication (Communicative Activity Log; Pulvermüller et al., 2001b) will be assessed at baseline T0 (time 0) and T1 (time 1).
Scale from 0 (minimum) to 5 (maximum) where higher scores indicate a better outcome.
Measured: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
Validation of usability of the technologies used
System Usability Scale (SUS) will be used as a measure of usability of the application.
Scale from 1 (minimum) to 5 (maximum) where higher scores indicate a better outcome.
Measured: This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.
Validation of usability, acceptability, and usefulness of the technologies used
mHealth App Usability Questionnaire (MAUQ) (Zhou, Bao, Setiawan, Saptono, \& Parmanto, 2019) will be used as a measure of usability, acceptability, and usefulness of the application.
Scale from 1 (minimum) to 7 (maximum), where higher scores indicate a better outcome.
Measured: This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.
Amount and time of use
Relationship between the total use of the application, measured in number of sessions and total time spent in minutes using the app, and improvement on the Barcelona test measured on scale from 0-365, where higher scores indicate a better outcome.
Measured: This will be measured continuously through the use of the application during the two weeks of use.
Cues used per practice session
Count of cues used by the subjects during the primary sessions of use of the application and compared to the final sessions of use of the application.
Measured: This will be measured continuously through the use of the application during the two weeks of use.
Reaction time on tasks in the application
Reaction time, measured in seconds, during the primary sessions of use of the application and compared to the final sessions of use of the application.
Measured: This will be measured continuously through the use of the application during the two weeks of use.
Subjects' own validation score of voice recordings
The validation score recorded from the application during the primary sessions of use of the application and compared to the final sessions of use of the application. Measured between 0 and 1 and represents the subject's score of how well they performed the task and recording.
Measured: This will be measured continuously through the use of the application during the two weeks of use.
Risk assessment
A custom questionnaire will be used to measure any risks associated with the use of the application.
Measured: This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start29 Nov 2021
- Primary completion16 Dec 2021
- Study completion29 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Aphasia, BrocaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either an experimental group or a control group. In the experimental group the participants will receive mobile-based aphasia therapy for two weeks. In the control group participants will receive no additional therapy apart from the conventional aphasia therapy that they are already receiving.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Bioengineering of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona., Universitat Pompeu Fabra
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274360
- Sponsor's protocol ID
- RNAAT2021
- Acronym
- RNAAT
- Status last verified
- Dec 2021
- First submitted
- 16 Nov 2021
- Last updated
- 10 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ameer K, Ali K. iPad Use in Stroke Neuro-Rehabilitation. Geriatrics (Basel). 2017 Jan 6;2(1):2. doi: 10.3390/geriatrics2010002.
PubMed 31011013Bakheit AM, Shaw S, Barrett L, Wood J, Carrington S, Griffiths S, Searle K, Koutsi F. A prospective, randomized, parallel group, controlled study of the effect of intensity of speech and language therapy on early recovery from poststroke aphasia. Clin Rehabil. 2007 Oct;21(10):885-94. doi: 10.1177/0269215507078486.
PubMed 17981847Brandenburg, C., & Power, E. (2019). Mobile Technology in Aphasia Rehabilitation: Current Trends and Lessons Learnt. Everyday Technologies in Healthcare, 293-317. https://doi.org/10.1201/9781351032186-16
Engelter ST, Gostynski M, Papa S, Frei M, Born C, Ajdacic-Gross V, Gutzwiller F, Lyrer PA. Epidemiology of aphasia attributable to first ischemic stroke: incidence, severity, fluency, etiology, and thrombolysis. Stroke. 2006 Jun;37(6):1379-84. doi: 10.1161/01.STR.0000221815.64093.8c. Epub 2006 May 11.
PubMed 16690899Grechuta 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.
PubMed 30913976Grechuta 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.
PubMed 32907594Griffith, J. (2018). Encyclopedia of Clinical Neuropsychology. Encyclopedia of Clinical Neuropsychology, 2-4. https://doi.org/10.1007/978-3-319-56782-2
Hallowell, B., & Chapey, R. (2012). Introduction to language intervention strategies in adult aphasia. Language Intervention Strategies in Aphasia and Related Neurogenic Communication Disorders: Fifth Edition, (November), 3-19.
Hidaka Y, Han CE, Wolf SL, Winstein CJ, Schweighofer N. Use it and improve it or lose it: interactions between arm function and use in humans post-stroke. PLoS Comput Biol. 2012 Feb;8(2):e1002343. doi: 10.1371/journal.pcbi.1002343. Epub 2012 Feb 16.
PubMed 22761551Hilari K, Needle JJ, Harrison KL. What are the important factors in health-related quality of life for people with aphasia? A systematic review. Arch Phys Med Rehabil. 2012 Jan;93(1 Suppl):S86-95. doi: 10.1016/j.apmr.2011.05.028. Epub 2011 Nov 25.
PubMed 22119074Hinckley JJ, Hasselkus A, Ganzfried E. What people living with aphasia think about the availability of aphasia resources. Am J Speech Lang Pathol. 2013 May;22(2):S310-7. doi: 10.1044/1058-0360(2013/12-0090).
PubMed 23695907Hirsch T, Barthel M, Aarts P, Chen YA, Freivogel S, Johnson MJ, Jones TA, Jongsma MLA, Maier M, Punt D, Sterr A, Wolf SL, Heise KF. A First Step Toward the Operationalization of the Learned Non-Use Phenomenon: A Delphi Study. Neurorehabil Neural Repair. 2021 May;35(5):383-392. doi: 10.1177/1545968321999064. Epub 2021 Mar 11.
PubMed 33703971Holland A, Fromm D, Forbes M, MacWhinney B. Long-term Recovery in Stroke Accompanied by Aphasia: A Reconsideration. Aphasiology. 2017;31(2):152-165. doi: 10.1080/02687038.2016.1184221. Epub 2016 May 27.
PubMed 28713191Kim J, Thayabaranathan T, Donnan GA, Howard G, Howard VJ, Rothwell PM, Feigin V, Norrving B, Owolabi M, Pandian J, Liu L, Cadilhac DA, Thrift AG. Global Stroke Statistics 2019. Int J Stroke. 2020 Oct;15(8):819-838. doi: 10.1177/1747493020909545. Epub 2020 Mar 9.
PubMed 32146867Maceira-Elvira P, Popa T, Schmid AC, Hummel FC. Wearable technology in stroke rehabilitation: towards improved diagnosis and treatment of upper-limb motor impairment. J Neuroeng Rehabil. 2019 Nov 19;16(1):142. doi: 10.1186/s12984-019-0612-y.
PubMed 31744553
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroscience-Based Aphasia Therapy Adapted to Remote, Mobile-Based Treatment
- ClinicalTrials.gov ID
- NCT05274360
- Acronym / sponsor ID
- RNAAT / RNAAT2021
- Conditions
- Aphasia, Broca, Aphasia, Wernicke, Aphasia, Fluent, Aphasia, Nonfluent, Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Institute for Bioengineering of CataloniaUniversity, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona., Universitat Pompeu Fabra
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is the development and validation of an evidence-based mobile application, based on the core premises of Intensive Language-Action Therapy (ILAT) for aphasia, for the training and improvement of chronic aphasia patients administered at the patient's home. It aims at testing the beneficial effect on the linguistic performance (as assessed by the Barcelona and CAL clinical tests) counteracting learned non-use and the usability of the application as a tool for training once discharged from hospital care.
Detailed description
Acquired brain lesions such as stroke often result in the most common disabling neurological damages. Up to 42% of stroke patients suffer serious language deficits and patients are frequently left with chronic disabilities which adversely impact their quality of life. One of the main challenges in aphasia rehabilitation includes long-term effects. After a certain time (i.e., 3-6mo, chronic phase), the frequency of therapy will decrease or stop, even if the patient has not always reached the expected or desired level of recovery. After this, a body of evidence suggests that the person with aphasia might decrease the use of verbal language given the negative reinforcement when trying to use the deteriorated function and failing to achieve a successful communication. This might lead to relying on other forms of communication (e.g., gestures) and to a vicious cycle of deterioration of verbal skills known as Learned Non-Use principle. Together with the pandemic socioeconomic situation and limited resources at healthcare facilities, this calls for the need of effective and efficient interventions that can be deployed at the house of the patients, in the form of auto-administered therapy. Despite the limited exploration of portable technologies in aphasia recovery, their use has been extensive and successful in other domains such as motor rehabilitation. Importantly, patients with aphasia report that the number 1 topic they would like to know more about is how to keep recovering after therapy ends.
Following recent evidence on experience-dependent plasticity mechanisms for successful stroke recovery and well-established theory-grounded interventions, such as ILAT, the present study aims to study the usability and improvement potential of a mobile-based aphasia rehabilitation app for stroke patients, used at home. A previous collaboration between both centers (SPECS lab and Hospital Joan XIII) used a computer-based setup. In this study by Grechuta et al. (2019), the Rehabilitation Gaming System for aphasia (RGSa) shows positive significant results on language (P= 0.001) and communication (P<0.05) compared to conventional therapy in the long term (16 weeks). This study will assess the usability, risks, and clinical outcome of the same principles applied to a mobile application that is prescribed to be used at home for two twenty-minutes session per day during two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to either an experimental group or a control group. In the experimental group the participants will receive mobile-based aphasia therapy for two weeks. In the control group participants will receive no additional therapy apart from the conventional aphasia therapy that they are already receiving.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Mobile evidence-based aphasia therapyMobile evidence-based aphasia therapy |
| Control Group | Active comparator | Behavioral: Conventional aphasia rehabilitationConventional aphasia therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with any type of aphasia
- 6 or more months have passed since the stroke (chronic stage)
- Age between 18 and 90 years
Key exclusion criteria (4 listed)
- Non-compliance with some of the inclusion criteria
- Presence of major perceptual, cognitive, motor, cognitive or neuropsychological pathology that can interfere with aphasia or 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
- Inability to understand the study participation
- Patients with an Android phone or tablet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile evidence-based aphasia therapyUse of mobile application to practice language for 2 weeks with a recommendation of 2 sessions per day of 20 minutes. The Android application, which is a Unity-based 2D game, will be installed on the patient's own phone, and they will play individually with the support of a family member if needed. The patients are free to start and stop using the application at any time. The application is safe to use, and it consists of therapeutic training methods such as object-matching, word search, writing, and manual voice recordings. | Behavioural | Experimental Group |
| Conventional aphasia rehabilitationControl Group (conventional aphasia rehabilitation). No therapy as patients are in the chronic stage, where they do not receive healthcare rehabilitation training. | Behavioural | Control Group |
Primary outcome
Within-group changes of language function
Time frame: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
Clinical scale for language (Barcelona Test) will be assessed at baseline T0 (prior to the use of the application) and T1 (after two weeks of use) for the experimental group. Scale from 0 (minimum) to 365 (maximum) where higher scores indicate a better outcome.
Within-group changes of communication
Time frame: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
Clinical scale for communication (Communicative Activity Log; Pulvermüller et al., 2001b) will be assessed at baseline T0 (prior to the use of the application) and T1 (after two weeks of use) for the experimental group. Scale from 0 (minimum) to 5 (maximum) where higher scores indicate a better outcome.
9 secondary outcomes
Between-group change of language function
Time frame: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
Between-group change of communication
Time frame: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
Validation of usability of the technologies used
Time frame: This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.
Validation of usability, acceptability, and usefulness of the technologies used
Time frame: This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.
Amount and time of use
Time frame: This will be measured continuously through the use of the application during the two weeks of use.
Cues used per practice session
Time frame: This will be measured continuously through the use of the application during the two weeks of use.
Reaction time on tasks in the application
Time frame: This will be measured continuously through the use of the application during the two weeks of use.
Subjects' own validation score of voice recordings
Time frame: This will be measured continuously through the use of the application during the two weeks of use.
Risk assessment
Time frame: This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Background: PubMed 31011013Ameer K, Ali K. iPad Use in Stroke Neuro-Rehabilitation. Geriatrics (Basel). 2017 Jan 6;2(1):2. doi: 10.3390/geriatrics2010002.
- Background: PubMed 17981847Bakheit AM, Shaw S, Barrett L, Wood J, Carrington S, Griffiths S, Searle K, Koutsi F. A prospective, randomized, parallel group, controlled study of the effect of intensity of speech and language therapy on early recovery from poststroke aphasia. Clin Rehabil. 2007 Oct;21(10):885-94. doi: 10.1177/0269215507078486.
- BackgroundBrandenburg, C., & Power, E. (2019). Mobile Technology in Aphasia Rehabilitation: Current Trends and Lessons Learnt. Everyday Technologies in Healthcare, 293-317. https://doi.org/10.1201/9781351032186-16
- Background: PubMed 16690899Engelter ST, Gostynski M, Papa S, Frei M, Born C, Ajdacic-Gross V, Gutzwiller F, Lyrer PA. Epidemiology of aphasia attributable to first ischemic stroke: incidence, severity, fluency, etiology, and thrombolysis. Stroke. 2006 Jun;37(6):1379-84. doi: 10.1161/01.STR.0000221815.64093.8c. Epub 2006 May 11.
- Background: PubMed 30913976Grechuta 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.
- Background: PubMed 32907594Grechuta 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.
- BackgroundGriffith, J. (2018). Encyclopedia of Clinical Neuropsychology. Encyclopedia of Clinical Neuropsychology, 2-4. https://doi.org/10.1007/978-3-319-56782-2
- BackgroundHallowell, B., & Chapey, R. (2012). Introduction to language intervention strategies in adult aphasia. Language Intervention Strategies in Aphasia and Related Neurogenic Communication Disorders: Fifth Edition, (November), 3-19.
- Background: PubMed 22761551Hidaka Y, Han CE, Wolf SL, Winstein CJ, Schweighofer N. Use it and improve it or lose it: interactions between arm function and use in humans post-stroke. PLoS Comput Biol. 2012 Feb;8(2):e1002343. doi: 10.1371/journal.pcbi.1002343. Epub 2012 Feb 16.
- Background: PubMed 22119074Hilari K, Needle JJ, Harrison KL. What are the important factors in health-related quality of life for people with aphasia? A systematic review. Arch Phys Med Rehabil. 2012 Jan;93(1 Suppl):S86-95. doi: 10.1016/j.apmr.2011.05.028. Epub 2011 Nov 25.
- Background: PubMed 23695907Hinckley JJ, Hasselkus A, Ganzfried E. What people living with aphasia think about the availability of aphasia resources. Am J Speech Lang Pathol. 2013 May;22(2):S310-7. doi: 10.1044/1058-0360(2013/12-0090).
- Background: PubMed 33703971Hirsch T, Barthel M, Aarts P, Chen YA, Freivogel S, Johnson MJ, Jones TA, Jongsma MLA, Maier M, Punt D, Sterr A, Wolf SL, Heise KF. A First Step Toward the Operationalization of the Learned Non-Use Phenomenon: A Delphi Study. Neurorehabil Neural Repair. 2021 May;35(5):383-392. doi: 10.1177/1545968321999064. Epub 2021 Mar 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile evidence-based aphasia therapy and Conventional aphasia rehabilitation in people with Aphasia, Broca and Aphasia, Wernicke, run by Institute for Bioengineering of Catalonia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-group changes of language function (time frame: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274360, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.