Feasibility and Acceptability of a Complex Telerehabilitation Intervention for Pediatric Acquired Brain Injury: The Child in Context Intervention (CICI).

The current study is a feasibility study of a randomized controlled trial (RCT): the Child in Context Intervention (CICI). The CICI study is an individualized, goal-oriented and home-based intervention conducted mainly through videoconference. It targets children with ongoing challenges (physical, cognitive, behavioral, social and/or psychological) after acquired brain injury (ABI) and their families at least one year post injury. The CICI feasibility study included six children aged 11-16 years with verified ABI-diagnosis, their families and their schools. The aim was to evaluate the feasibility of the intervention components, child and parent perceptions of usefulness and relevance of the intervention as well as the assessment protocol through a priori defined criteria. Overall, the families and therapists rated the intervention as feasible and acceptable, including the videoconference treatment delivery. However, the burden of assessment was too high. The SMART-goal approach was rated as useful, and goal attainment was high. The parents' ratings of acceptability of the intervention were somewhat higher than the children's. In conclusion, the CICI protocol proved feasible and acceptable to families, schools and therapists. The assessment burden was reduced, and adjustments in primary outcomes were made for the definitive RCT.

Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial.

BACKGROUND: Pediatric acquired brain injury (pABI) is associated with long-term cognitive, behavioral, social, and emotional problems, which may affect the quality of life, school, and family functioning. Yet, there is a lack of evidence-based community-centered rehabilitation programs for chronic pABI and these children do not systematically receive comprehensive rehabilitation. The Child In Context Intervention (CICI) study is a pragmatic randomized controlled trial (RCT) for children with chronic pABI, which aims to evaluate the effectiveness of an individualized and goal-oriented intervention targeting everyday functioning of the child and family. METHODS: Children aged 6-16 years with MRI/CT-verified intracranial abnormalities will be included in the CICI study if they have persistent self- or parent-reported cognitive, emotional, and/or behavioral challenges 1 year or more after insult and attend school regularly. A total of 70 families will be randomized 1:1 to an intervention or a control group. The intervention consists of seven family sessions, one parent seminar, and four school sessions delivered over approximately 6 months. The parent seminar will be held in person, and the other sessions will mainly be video based. The children's and families' self-reported major challenges in everyday life will be targeted using SMART goals. Evidence-based strategies, when available, will be applied to achieve the goals, combined with psychoeducation. Goal attainment scaling (GAS) will be used to evaluate goal attainment. Data is collected at baseline and after approximately 6 and 9 months. External assessors are blinded to group allocation. Primary outcomes are parent-reported brain injury symptoms in children and parenting self-efficacy at 9 months of follow-up. Secondary outcomes include child-reported brain injury symptoms, quality of life, executive functioning in daily life, parent emotional symptoms, family functioning, and unmet family health care needs. A process evaluation will be conducted. DISCUSSION: The current study provides an innovative approach to rehabilitation for children in the chronic phase of ABI and their families. This complex intervention may contribute to the development of evidence-based, high-quality rehabilitation for a large patient group, which is underrepresented in clinical research. It may also improve collaboration between specialized rehabilitation facilities, schools, and local health care services. Inclusion for the trial started in April 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT04798859 . Registered on March 15, 2021.

Technical Features, Feasibility, and Acceptability of Augmented Telerehabilitation in Post-stroke Aphasia-Experiences From a Randomized Controlled Trial.

Background: Post-stroke aphasia is a communication disorder where existing evidence favors intensive therapy methods. Telerehabilitation represents a service model for geographically remote settings, or other barriers to clinic attendance or to facilitate an augmentation of therapy across a continuum of care. Evidence to support efficiency, feasibility, and acceptability is however still scarce. Appraising aphasia telerehabilitation in controlled trials beyond its effectiveness, by investigating feasibility and acceptability, may facilitate implementation into clinical practice. Methods: In our pilot randomized controlled trial, we investigated the feasibility and acceptability of speech and language therapy by videoconference, in addition to usual care, in people with aphasia following stroke. To improve functional, expressive language, a tailored intervention was given 1 h per day, five times per week over four consecutive weeks. Feasibility measures included evaluation of technical setup using diary logs. Acceptability was investigated by examining adherence and satisfaction with therapy alongside evaluation of data safety and privacy. Results: Feasibility and acceptability data were collected in relation to 556.5 h of telerehabilitation delivered to 30 participants over a 2-years intervention period by three speech-language pathologists. Protocol adherence was high, with a tolerable technical fault rate; 86 faults were registered over 541 video sessions. Most (80%; n = 30) of the participants experienced zero to three faults. The main cause of technical failures was flawed internet connection, causing delayed or interrupted therapy. Total satisfaction with telerehabilitation was rated good or very good by 93.1% (n = 29) of participants and two of three speech-language pathologists. Within a moderate variance of technical failure, participants experiencing more faults were more satisfied. No serious events regarding security and privacy were reported. Our model is feasibly and ready to be implemented across a range of clinical settings and contexts. Conclusions: Synchronous telerehabilitation for post-stroke aphasia is feasible and acceptable and shows tolerable technical fault rates with high satisfaction among patients and pathologists. Within a low rate of faults, satisfaction was not negatively influenced by fault frequency. Access to clinical and technical expertise is needed when developing telerehabilitation services. Telerehabilitation may be a viable service delivery model for aphasia rehabilitation. Trial Registration: ClinicalTrials.gov, ID: NCT02768922.

The effect of augmented speech-language therapy delivered by telerehabilitation on poststroke aphasia-a pilot randomized controlled trial.

OBJECTIVE: Pilot a definitive randomized controlled trial of speech-language telerehabilitation in poststroke aphasia in addition to usual care with regard to recruitment, drop-outs, and language effects. DESIGN: Pilot single-blinded randomized controlled trial. SETTING: Telerehabilitation delivered from tertiary rehabilitation center to participants at their home or admitted to secondary rehabilitation centers. SUBJECTS: People with naming impairment due to aphasia following stroke. INTERVENTION: Sixty-two participants randomly allocated to 5 hours of speech and language telerehabilitation by videoconference per week over four consecutive weeks together with usual care or usual care alone. The telerehabilitation targeted functional, expressive language. MAIN MEASURES: Norwegian Basic Aphasia Assessment: naming (primary outcome), repetition, and auditory comprehension subtests; Verb and Sentence Test sentence production subtest and the Communicative Effectiveness Index at baseline, four weeks, and four months postrandomization. Data were analyzed by intention to treat. RESULTS: No significant between-group differences were seen in naming or auditory comprehension in the Norwegian Basic Aphasia Assessment at four weeks and four months post randomization. The telerehabilitation group (n = 29) achieved a Norwegian Basic Aphasia Assessment repetition score of 8.9 points higher (P = 0.026) and a Verb and Sentence Test score 3 points higher (P = 0.002) than the control group (n = 27) four months postrandomization. Communicative Effectiveness Index was not significantly different between groups, but increased significantly within both groups. No adverse events were reported. CONCLUSION: Augmented telerehabilitation via videoconference may be a viable rehabilitation model for aphasia affecting language outcomes poststroke. A definitive trial with 230 participants is needed to confirm results.

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

BACKGROUND: The Cochrane review on the effectiveness of speech and language therapy for aphasia following stroke suggests intensity of therapy is a key predictor for outcome. Current aphasia services cannot provide intervention at the intensity observed within trial contexts because of resource limitations. Telerehabilitation could widen access to speech-language pathologists (SLPs) in geographically remote contexts and reduce the time spent on travel by the therapist and patient. The current academic literature within this field is in its infancy, with few trials of speech and language therapy (SLT) delivered by videoconference. Our pilot randomized controlled trial (RCT) will explore feasibility aspects and effectiveness of telerehabilitation for aphasia in addition to standard SLT. METHOD/DESIGN: Our study is a pragmatic, exploratory, pilot randomized controlled trial, where participants will be randomized to a telerehabilitation group or a control group. Both groups receive standard SLT (usual care) but the telerehabilitation group receives an additional 5 h of telerehabilitation per week over 4 weeks through videoconference. This additional telerehabilitation focuses on spoken language with an emphasis on word naming. We aim to include 40 patients in each group, with inclusion criteria being aphasia any time post stroke. Participants will be assessed blindly at pre-randomization (baseline), and 4 weeks and 4 months after randomization. The primary endpoint is naming ability 3 months after the completed intervention, measured by the Norwegian Basic Aphasia Assessment (NGA) naming subtest. Secondary endpoints include other subtests of the NGA, the VAST (Verb and Sentence Test) subtest sentence production, Communicative Effectiveness Index (CETI) and the Stroke and Aphasia Quality of Life scale (SAQOL-39). Experiences of patients and SLPs with telerehabilitation are assessed using questionnaires and semi-structured interviews. Statistical between group comparisons will be in line with an intention-to-treat analysis. DISCUSSION: This pilot RCT of intensive language training by videoconference will contribute new scientific evidence to the field of aphasia telerehabilitation. Here, we describe our trial which will explore the feasibility of telerehabilitation for aphasia as an intervention, our choice of primary and secondary outcome measures and proposed analyses. Our trial will provide information for the development and delivery of future definitive RCTs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02768922 . Registered on 11 May 2016. Last updated on 17 November 2017.