A Trial Investigating Telerehabilitation as an add-on to Face-to-face Speech and Language Therapy in Post-stroke Aphasia.

NCT03228264 | Completed

• 1 other identifier: 2016-01577
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to investigate the effects of high-frequency short duration tablet-based speech and language therapy (teleSLT) mixed with cognitive training (teleCT) in chronic stroke patients. Recent studies suggest that chronic stroke patients benefit from SLT with high frequency and that cognitive abilities can play a role in sentence comprehension and production by individuals with aphasia. To investigate the effects of the distribution of training time for teleSLT and teleCT the investigators use two combinations. In the experimental group 80% of the training time will be devoted to teleSLT and 20% to teleCT whereas in the control group 20% of the training time will be devoted to teleSLT and 80% to teleCT. Both groups receive the same total amount and frequency of intervention but with different distributions. At three time points (pre-, post-test and 8 week follow-up) the patients' word finding ability is measured.

Conditions

Aphasia; Chronic Stroke; Post Stroke Seizure

Outcome Measures

Primary Outcomes (3)

• Understandability of verbal communication

  The understandability of verbal communication is assessed with the A-scale of the Amsterdam-Nijmegen Everyday Language Test (ANELT). For this scale, oral answers in ten everyday life scenarios are scored with respect to understandability of the message, i.e. the content of the message independent of the linguistic form of the utterance (Blomert, Kean, Koster, \& Schokker, 1994). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place at the beginning of the intervention.

  Pre-test (Baseline, week 0)

• Understandability of verbal communication

  The understandability of verbal communication is assessed with the A-scale of the Amsterdam-Nijmegen Everyday Language Test (ANELT). For this scale, oral answers in ten everyday life scenarios are scored with respect to understandability of the message, i.e. the content of the message independent of the linguistic form of the utterance (Blomert, Kean, Koster, \& Schokker, 1994). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place at the end of the intervention.

  Post-test (Change from Baseline at week 4)

• Understandability of verbal communication

  The understandability of verbal communication is assessed with the A-scale of the Amsterdam-Nijmegen Everyday Language Test (ANELT). For this scale, oral answers in ten everyday life scenarios are scored with respect to understandability of the message, i.e. the content of the message independent of the linguistic form of the utterance (Blomert, Kean, Koster, \& Schokker, 1994). The measurement is performed in a face-to-face interaction between the patients and the evaluator and takes place eight weeks after the intervention.

  8 week follow-up (Change from Baseline at week 12)

Secondary Outcomes (9)

• Intelligibility of verbal communication

  Pre-test (Baseline, week 0)

• Intelligibility of verbal communication

  Post-test (Change from Baseline at week 4)

• Intelligibility of verbal communication

  8 week follow-up (Change from Baseline at week 12)

• Impairment specific language measures

  Pre-test (Baseline, week 0)

• Impairment specific language measures

  Post-test (Change from Baseline at week 4)

Study Arms (2)

High teleSLT frequency

EXPERIMENTAL

During four weeks all patients will do a daily two-hour training session with a tablet computer (consisting of teleSLT and teleCT) at their home. In the experimental group 80% of the training time will be devoted to teleSLT and 20% to teleCT. Both groups receive the same amount of ucSLT.

Device: teleSLT; Device: teleCT

Low teleSLT frequency

ACTIVE COMPARATOR

During four weeks all patients will do a daily two-hour training session with a tablet computer (consisting of teleSLT and teleCT) at their home. In the control group 20% of the training time will be devoted to teleSLT and 80% to teleCT. Both groups receive the same amount of ucSLT.

Device: teleSLT; Device: teleCT

Interventions

teleSLT DEVICE

The teleSLT intervention consists of a daily training session with a tablet computer at the patients' home. The teleSLT application that will be used for this study was developed within a multidisciplinary team of speech and language therapists, neurologists and computer engineers that have transferred well-established SLT exercises to a tablet computer. The investigators call this application Bern Aphasia App (BAA). During the four weeks the training time with the BAA differs between the two arms. The experimental group trains for 96 minutes per day (80% of two hours) and the control group for 24 minutes per day (20% of two hours).

High teleSLT frequency; Low teleSLT frequency

teleCT DEVICE

For the cognitive training the investigators will use two custom-made versions of popular commercial casual puzzle video games: Flow Free (Big Duck Games LCC) and Bejeweled (PopCap Games). The video games are also delivered on tablet-computers. Again, during the four weeks the training time differs between the two arms. The experimental group trains for 24 minutes and the control group for 96 minutes per day.

High teleSLT frequency; Low teleSLT frequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or over.
• Diagnosis of aphasia due to stroke, as confirmed by a speech and language therapist.
• Raw value for the German version of the Token Test (De Renzi \& Vignolo, 1962) has to be smaller or equal to 8 (T-value smaller or equal to 60).
• Sufficient vision and cognitive ability to work with the teleSLT software (a simple matching task on the tablet computer will be used to test this).
• Written informed consent.

You may not qualify if:

• Any other pre-morbid speech and language disorder caused by a deficit other than stroke.
• Requirement for treatment in language other than German.
• Currently using a computer speech therapy software.

Sponsors & Collaborators

• University of Bern: lead

Study Sites (2)

ARTORG Center for Biomedical Engineering Research

Bern, 3008, Switzerland

Location

Center for Neurology and Neurorehabilitation

Lucerne, 6000, Switzerland

Location

Related Publications (13)

• Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. doi: 10.1161/01.STR.0000062343.64383.D0. Epub 2003 Mar 20.

  PMID: 12649521 BACKGROUND

• Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;(5):CD000425. doi: 10.1002/14651858.CD000425.pub3.

  PMID: 22592672 BACKGROUND

• Caplan D, Waters G. Memory mechanisms supporting syntactic comprehension. Psychon Bull Rev. 2013 Apr;20(2):243-68. doi: 10.3758/s13423-012-0369-9.

  PMID: 23319178 BACKGROUND

• Crotty M, George S. Retraining visual processing skills to improve driving ability after stroke. Arch Phys Med Rehabil. 2009 Dec;90(12):2096-102. doi: 10.1016/j.apmr.2009.08.143.

  PMID: 19969174 BACKGROUND

• Kendall DL, Oelke M, Brookshire CE, Nadeau SE. The Influence of Phonomotor Treatment on Word Retrieval Abilities in 26 Individuals With Chronic Aphasia: An Open Trial. J Speech Lang Hear Res. 2015 Jun;58(3):798-812. doi: 10.1044/2015_JSLHR-L-14-0131.

  PMID: 25766309 BACKGROUND

• Sandberg CW, Bohland JW, Kiran S. Changes in functional connectivity related to direct training and generalization effects of a word finding treatment in chronic aphasia. Brain Lang. 2015 Nov;150:103-16. doi: 10.1016/j.bandl.2015.09.002. Epub 2015 Sep 20.

  PMID: 26398158 BACKGROUND

• Wang CP, Hsieh CY, Tsai PY, Wang CT, Lin FG, Chan RC. Efficacy of synchronous verbal training during repetitive transcranial magnetic stimulation in patients with chronic aphasia. Stroke. 2014 Dec;45(12):3656-62. doi: 10.1161/STROKEAHA.114.007058. Epub 2014 Nov 6.

  PMID: 25378426 BACKGROUND

• Zakarias L, Keresztes A, Marton K, Wartenburger I. Positive effects of a computerised working memory and executive function training on sentence comprehension in aphasia. Neuropsychol Rehabil. 2018 Apr;28(3):369-386. doi: 10.1080/09602011.2016.1159579. Epub 2016 Mar 21.

  PMID: 26999324 BACKGROUND

• Blomert L, Kean ML, Koster C, Schokker, J. Amsterdam-Nijmegen everyday language test: construction, reliability and validity. Aphasiology 8(4): 381-407, 1994.

  BACKGROUND

• Blömer F, Pesch A, Willmes K, Huber W, Springer L, Abel S. Das sprachsystematische Aphasiescreening (SAPS): Konstruktionseigenschaften und erste Evaluierung. Zeitschrift für Neuropsychologie 24(3): 139-148, 2013.

  BACKGROUND

• Hilari K, Byng S, Lamping DL, Smith SC. Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39): evaluation of acceptability, reliability, and validity. Stroke. 2003 Aug;34(8):1944-50. doi: 10.1161/01.STR.0000081987.46660.ED. Epub 2003 Jul 10.

  PMID: 12855827 BACKGROUND

• DE RENZI E, VIGNOLO LA. The token test: A sensitive test to detect receptive disturbances in aphasics. Brain. 1962 Dec;85:665-78. doi: 10.1093/brain/85.4.665. No abstract available.

  PMID: 14026018 BACKGROUND

• Uslu AS, Gerber SM, Schmidt N, Rothlisberger C, Wyss P, Vanbellingen T, Schaller S, Wyss C, Koenig-Bruhin M, Berger T, Nyffeler T, Muri R, Nef T, Urwyler P. Investigating a new tablet-based telerehabilitation app in patients with aphasia: a randomised, controlled, evaluator-blinded, multicentre trial protocol. BMJ Open. 2020 Nov 11;10(11):e037702. doi: 10.1136/bmjopen-2020-037702.

  PMID: 33177134 DERIVED

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tobias Nef, Prof. Dr.

  Gerontechnology and Rehabilitation, ARTORG Centre for Biomedical Engineering Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a randomized, controlled, evaluator-blinded multi-center superiority trial with two parallel groups and with word finding ability as primary endpoint at the end of the intervention. Aphasia outpatients will be recruited and randomly assigned to the experimental or control group. The randomization will be stratified by the study centre (Bern, Luzern) and the severity of aphasia (mild with a raw value/T-value smaller than 5/52, severe with a raw value/T-value greater or equal to 5/52 for the Token Test). Both groups will do a four weeks intensive tablet-delivered telerehabilitation training (2 hours a day).

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 24, 2017
• Study Start: September 25, 2018
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)