Telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial

Today, stroke stands as a major and leading cause of disability worldwide. Each year, one estimates that about 11,000 people in Norway acquire their first stroke [1]. In Norway, stroke is the most common cause of disability in the older population, with a stable incidence for the last decade due to better preventive treatment and acute management [1]. An aging European population in combination with an improvement in the survival rates of stroke is expected to put an increased burden on the health care system in the years to come.

One of the most devastating consequences of stroke is aphasia, a disturbance in language function which can affect the ability to speak and includes difficulties with speech production, auditory comprehension, as well as reading and writing. It affects one third of stroke survivors [2], where about 60% of the patients show consistent communication impairment 1 year post stroke [3]. Aphasia impacts on the rehabilitation process, affecting rehabilitation outcomes in a negative manner. The presence of aphasia following stroke is a negative predictor for return to workforce [4]. People with aphasia report significantly worse health-related quality of life (HRQL) than stroke survivors without aphasia [5]. Hence, aphasia affects stroke survivors’ social life by isolating them from social networks and limiting social participation [6]. Furthermore, aphasia impacts on significant others, describing third-party disability in family members [7]. Effective rehabilitation for aphasia is vital to recovery.

As the future holds an increasingly aged population, the urgency to develop evidence-based, cost-effective interventions to improve rehabilitation of people with aphasia is profound [8]. The aim of aphasia rehabilitation is an improvement in speech and language functions, where speech and language therapy (SLT) is considered to be “gold standard.” Several studies claim that intensive SLT improves outcomes in aphasia [9‐11]. The updated Cochrane review from 2016 on the effects of SLT for aphasia following stroke, provides evidence of the effectiveness of SLT in terms of improved functional communication, reading, writing and expressive language compared to no access to therapy [8]. This meta-analysis furthermore concludes that there is some evidence that therapy at high intensity, high dose or over a longer period may be beneficial compared to lower intensity, lower dose or over a shorter period of time [8]. Today, a wide range of different forms of therapy exists, from constraint-induced language therapy (CILT) and functional-orientated therapy to phonological, semantic and cognitive-linguistic approaches. To date, the evidence for the best therapeutic approach, and details about timing, frequency, duration, intensity and dose, is still unclear for the overall aphasia population.

Access to SLT services, the recruitment and retention of speech-language pathologists (SLPs) remains a problem worldwide [12]. In rural countries like Norway, providing tailored aphasia rehabilitation of sufficient intensity and duration is a challenge. An early start to rehabilitation, meeting the Norwegian national guidelines of ≥ 5 h of SLT per week [13], seems not to be provided for reasons as the lack of SLPs and a limited capacity for aphasia services in the municipalities [14]. There is a unique opportunity to use telemedicine solutions for providing therapy. Telerehabilitation represents a future service delivery model for aphasia beyond the traditional gold standard of “face-to-face” treatment [15]. Telerehabilitation has been defined as rehabilitation services delivered via information and communication technology, and is categorized as rehabilitation services provided at a distance [16, 17]. It has the potential to widen the access to SLPs with promise of better and more equitable services. However, the academic literature on aphasia telerehabilitation is yet in its infancy, with substantial gaps in the scientific evidence of the feasibility and effectiveness of this therapy approach. This seems to be the case for stroke rehabilitation in general, as a Cochrane review of all types of telerehabilitation services for stroke has concluded that there is limited trials and evidence to guide practice [18]. Studies of the use of videoconference in aphasia interventions is especially lacking, with only one pilot RCT on the effectiveness of telerehabilitation by videoconference included in the published Cochrane review on aphasia following stroke [19]. Thus, the need to provide high-quality RCTs to contribute scientific evidence and knowledge to this relatively new field of aphasia research is a priority.

There are barriers and advantages with telerehabilitation activities in SLT as elaborated in a recent review [20]. A great advantage is higher availability of treatment facilitating shorter waiting lists and reducing potential delay of treatment. Telerehabilitation can reduce traveling time and costs for both patient and therapist. As treatment takes place in the patient’s home environment, the rehabilitation can be goal orientated toward the patient’s everyday life, with greater involvement of family and caregivers [20]. Telemedicine uses computer-based technology, which might enable the use of interactive computer-based therapy programs, videogames or social media [21]. Following stroke, significant fatigue and motor dysfunction can make traveling to receive therapy a challenging task. By receiving therapy in the home, patients with fatigue can focus their energies on aphasia rehabilitation rather than the journey to the rehabilitation centre [15]. Favorable patient satisfaction with telerehabilitation has been described [22, 23]. Despite these advantages, there are several barriers that hinder the routine implementation of telerehabilitation into a clinical setting. To date, we lack cost-benefit and cost-effectiveness analyses on telerehabilitation. There are ethical issues and threats to privacy and confidentiality to address. The lack of infrastructure, technical and/or personal support, funding of equipment and the lack of reimbursement are other issues to consider [20].

We previously conducted a feasibility study to explore the feasibility of delivering SLT by videoconference [24]. Tailored speech-language therapy was tested through videoconference in four patients with aphasia. Patient satisfaction and feasibility aspects were mapped through logs, questionnaires and semi-structured interviews. Aphasia rehabilitation via videoconference was found to be acceptable to both patient and therapist, and considered sustainable and feasible with regards to technical, logistic, patient and data safety aspects [24]. In this article we present the protocol of a pragmatic, exploratory, pilot randomized controlled trial (RCT) of standard SLT augmented by additional hours of SLT by videoconference compared to standard SLT alone. This pilot trial targets a larger, randomized sample size recruited across a number of sites, providing a better understanding of feasibility and new technical arrangements beyond our earlier feasibility study.

Due to ethical issues we have chosen a design were we compare the effects of aphasia telerehabilitation alongside standard SLT (usual care) with standard SLT only. To date, we have limited evidence of the effectiveness of telerehabilitation, which limits the application of SLT via videoconference as a treatment option.

As already tested in our feasibility study [24], we will use videoconference software and equipment installed at Sunnaas Rehabilitation Hospital and in study laptops given to the participants. The videoconference software is delivered by the “Norwegian Health Net (NHN),” a company owned by the Ministry of Health and Care services. Videoconference is provided through encrypted software which meets requirements with regards to data safety aspects, privacy and confidentiality. As the therapy sessions are live, there are no recordings or storage of video, sound or picture. The software we will use for the videoconference is Cisco Jabber/ Acano. In addition, the SLPs will also use the software called LogMeIn which allows the therapist to remotely control the participant’s computer, and has been shown to be a valuable tool in delivering therapy and assistance should technical problems arise [24].

Our current technical setup builds upon experience from the feasibility study “Language training straight home” [24]. In this former feasibility study some areas for improvement were identified which have been integrated in the present protocol. To maintain safety aspects a checklist has been implemented to be used at the start of each therapy session to control and adjust the patient’s physical environment. This is to ensure optimal training conditions, preserve accurate procedures in case of emergency and to accommodate privacy issues. When it comes to the technical aspects of delivering aphasia rehabilitation by videoconference, one expects to encounter technical challenges not revealed during the small feasibility study (n = 4). A separate log to map technical error has been developed and integrated into the protocol. Furthermore, the technical solutions tested in the feasibility study have been improved compared to the original technical setup. This includes a separate speaker to improve sound quality and a wide-angle web camera to enable the therapist to see the patient’s upper body in case alternative communication approaches, such as the use of body language and/or gestures, are needed.

No large RCTs have been carried out within the field of aphasia telerehabilitation, especially with the use of videoconference SLT. Previous studies have used interventions not applicable with the current protocol, and have been of varying quality and used small sample sizes. We were, therefore, unable to calculate an a prior accurate sample size. Thus, our pilot RCT will support a more accurate sample size estimate and to inform a definitive trial of the effect of intensive telerehabilitation for aphasia. We will investigate possible effects using the percentile score of the NGA naming subtest where we consider the minimal clinically meaningful effect to be an improvement of 8 percentile scores. Given a standard deviation of 18.17 (based on recently collected data from another project without telerehabilitation), 32 participants will be sufficient to detect a significant improvement within a group between time points using a pairwise comparison, with a significance level of 5 and a power of 80. This will enable the study to make some suggestions on effectivity. Considering possible dropouts, the study aims to include 40 participants in each group, with a total number of 80 subjects. We anticipate that results from this pilot RCT will yield data to inform a more accurate sample size calculation for future definitive RCTs.

Data will be analyzed on an intention-to-treat basis. Descriptive statistics will be applied and the characteristics of the sample will be described. The trial is a longitudinal study with continuous repeated measurements. The data will be analyzed by using mixed models. A mixed model is preferred to the more traditional repeated measures analysis of variance (ANOVA) because of its advantages in the way in which it accommodates missing values. Data will be examined for differences over time and between groups. Subgroup analysis will be performed to explore factors considered to affect the outcome of the trial like differences in time since onset of stroke or demographic and stroke-related factors. Qualitative data collected from semi-structured interviews will be suitably coded for qualitative responses to be categorized and examined.

This protocol describes a pragmatic, pilot randomized controlled trial (phase II exploratory trial) that should make a valuable contribution to the field of aphasia telerehabilitation.

This trial’s objective is to investigate the feasibility and effectiveness of augmented SLT delivered via videoconference in addition to the standard SLT that the participants are already receiving. To our knowledge, there are no RCTs of this size that have explored the use of videoconferencing in providing an augmented, intensive SLT intervention for aphasia after stroke.

Our trial will look at the feasibility of scaling the intervention up for a larger trial and clinical implementation. Future studies may draw upon our findings if the trial is shown to be feasible, not harmful and indicates effects to be explored beyond this pilot. Our trial might offer some insight into videoconferencing as an effective mode of delivering speech and language interventions in the rehabilitation of people with aphasia, as we have chosen also to investigate clinically meaningful improvement. The trial does not meet sample size based on our assumptions for power calculation; however, large effect sizes might result in significant effects possibly influencing clinical practice. The main purpose of the study, however, is to contribute to the development of future fully powered definitive trials on the effectiveness of this therapy approach, also compared to – and not only in addition to – standard care.

A recent review of the effectiveness of SLT for post-stroke aphasia [8] suggests that intensity may be a key predictor for outcome. This trial investigates the feasibility of telerehabilitation as a supplement to increase the intensity of therapy within aphasia services with limited resources amongst a patient population with common mobility problems and fatigue within a geographically remote context. If telerehabilitation can be used within such a setting, our trial may demonstrate potential for change in future practice. Future studies examining SLT via videoconference as an alternative to usual care will be informed by this study. By shedding light on feasibility aspects through the data gathered using qualitative research methods and logs to map technical errors, we will expect to develop a greater understanding of SLT via videoconference.

When it comes to evaluate the feasibility of telerehabilitation for aphasia, broad participant inclusion criteria in this trial may be regarded as strength. Recent evidence suggests that there may be an interaction between timing post stroke and tolerance of high-intensity SLT [8]. By including participants at all stages of aphasia, from acute to chronic, the data will be more clinically representative for evaluating feasibility features, and of greater ecological validity to the population of people with aphasia. This trial is pragmatic in nature, and due to ecological validity, practicability and ethical issues, we have chosen to examine the effect of additional aphasia telerehabilitation alongside standard SLT in comparison to standard SLT only. As telerehabilitation is relatively new to the field of aphasia research and there is limited pre-existing evidence for the primary and secondary outcomes of our trial, it is considered unethical to prevent the patients from receiving usual care. Thus, an added benefit of this design is to reassure potential participants that randomization may augment their access to therapy and not restrict it.