Aphasia Telerehabilitation

NCT ID: NCT02768922

Aphasia Telerehabilitation Early Post Stroke
This study aims at contributing with scientific evidence to the field of aphasia telerehabilitation. In Norway today, there is an unmet need for language training in post stroke aphasia and not all patients are offered language training. Early start of aphasia rehabilitation and satisfying intensity do not seem to be standard clinical practice. Language training by telemedicine could improve this situation, and this study seeks to answer the question whether aphasia rehabilitation delivered by telemedicine can improve language function in aphasia early post stroke.
BACKGROUND: About 25 % of all stroke cases lead to aphasia. Aphasia can include difficulties with speech production and comprehension, as well as reading and writing impairment. Language impairment affects post stroke rehabilitation in a negative manner. Quality of life is reduced in persons with aphasia compared to stroke victims without aphasia. Speech and language therapy is the main form of aphasia rehabilitation. The most updated Cochrane review indicates that intensive speech and language therapy is more effective than therapy of lower intensity. Current aphasia services in Norway do not seem to be in accordance with the national guidelines for treatment and rehabilitation of stroke. The capacity for aphasia rehabilitation at the community level is too small and there is a lack of speech and language therapists. Language training by telemedicine could improve this unmet need for language training in post stroke aphasia. The literature within this field is however sparse and there is also a substantial lack of studies showing the effectiveness of telerehabilitation. Financed by the Norwegian Foundation for Health and Rehabilitation, the investigators have earlier performed a pilot project at Sunnaas Rehabilitation Hospital in cooperation with the Norwegian Centre for Integrated Care and Telemedicine. This pilot study showed that language training by telemedicine is feasible with regard to technical, practical and rehabilitation aspects. The pilot study laid ground for a larger and controlled study. OBJECTIVE: The project aims at contributing with scientific evidence to the field of aphasia telerehabilitation. The study seeks to answer the question whether aphasia rehabilitation delivered by telemedicine can improve language function in post stroke aphasia. The investigators also want to investigate the effect on patient's quality of life and how this form of therapy is experienced by patients and therapists. DESIGN: The study will be conducted as a randomized controlled clinical trial (RCT) with an intervention and a control group. The post intervention testing and follow up will be blinded and performed by speech and language therapist unknown to the patient's allocation. PARTICIPANTS: Patients will be recruited from the stroke units at Oslo University Hospital Ullevål, Akershus University Hospital, Østfold Hospital, Lovisenberg Hospital and Diakonhjemmet Hospital. A power analysis has been performed for the main effect measure. Based on power analysis, 32 participants have to be included in each group. Considering some drop out, one plans to include 40 participants in each group, with a total number of 80 subjects. The investigators will include patients with recently acquired stroke with aphasia including naming impairment. Patients under the age of 16 years and patients who are unable to perform 5 hours of speech and language therapy per week due to medical or cognitive reasons, will be excludes INTERVENTION: The intervention group will receive speech and language therapy via telemedicine, while the control group will not receive any specific therapy as part of this study. Both groups will receive standard aphasia rehabilitation. The amount of standard aphasia rehabilitation will be logged in all participants. Participants in the intervention group will receive daily language training of 1 hour for 5 days over 4 weeks. The telemedicine language training will be performed via internet from Sunnaas Rehabilitation Hospital to the laptop in the participants home. As already tested in the pilot study, the investigators will use the technical solution "Cisco Jabber Video" and the remote control software "LogMeIn", in the telerehabilitation that is given. PROCEDURES: The stroke units will refer patients, which fulfill the inclusion criteria, to Sunnaas Rehabilitation Hospital for language training. Shortly before discharge from the stroke unit, an ambulatory visit from Sunnaas will be performed where informed consent will be requested, and - in case the patient is willing to participate in the study - assessment will be carried out. The pretesting at the stroke unit will mainly by conducted by the PhD-candidate and/or by the Speech and language therapists in the project. The testing will be performed before the randomization procedure is taken place. After randomization, the participant will receive a laptop and training in the use of the computer for telerehabilitation purposes will be given. The post-intervention testing and follow-up-testing, will be blinded and performed by speech and language therapists unknown to the allocation of the participants. Directly after the intervention period (4 weeks), the participant will be visited at home or come to the outpatient clinic at Sunnaas hospital. The laptop will be retrieved and assessment performed. The control group will be tested at the corresponding time point. A further follow-up assessment will be performed 3 months later in all participants. OUTCOME MEASURES: To investigate the effect of aphasia rehabilitation delivered by telemedicine, the investigators have chosen to look especially on naming as a measure of expressive language function. The investigators want to regard the prolonged effect of aphasia telerehabilitation on language function. Further on the investigators want to see the effect immediately after intervention and on other language functions than naming. The investigators also want to investigate whether language training by telemedicine can affect quality of life, and how persons with aphasia and therapists experience the use of telerehabilitation early after stroke. For the assessment of language functioning, the Norwegian Basic Aphasia Assessment (NGA) with the subtests conversational interview, naming, repetition and comprehension will be used.The test will be carried out continued through the entire selected subtest, that is the test will be performed without interruption as a result of too many mistakes, as originally intended in the Norwegian Basic Aphasia Assessment manual. To assess the ability of sentence production, the investigators will use the Verb and Sentence Test (VAST) subtest nr 7. Functional communication will be assessed using Communicative Effectiveness Index (CETI). Quality of life will be assessed using Stroke and Aphasia Quality of Life scale (SAQOL-39). In addition, the experiences of patients, relatives and therapists with the telerehabilitation services will be assessed using a questionnaire as well as semi-structured interviews with selected patients. There will be an interview with the therapist performing the telerehabilitation. Primary endpoint: Naming ability 3 months after completed intervention. Secondary endpoints: - Language functions other than naming (repetition, comprehension, sentence production) 3 months after completed intervention - Functional communication and quality of life 3 months after completed intervention. - Naming and other language functions immediately after intervention. ANALYSES AND STATISTICS: The investigators will use linear regression and an intention to-treat (ITT) analysis.
Stroke, Aphasia
Telemedicine, Telerehabilitation, Speech and language therapy
Sunnaas Rehabilitation Hospital
Sunnaas Rehabilitation Hospital, South-Eastern Norway Regional Health Authority
Last Updated
08 May 2016
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