IntroductionA growing number of children and young people are surviving severe acquired brain injuries due to advances in healthcare. However, many fail to emerge from coma and continue to live with disorders of consciousness (DOC). Diagnostic, clinical and ethical challenges are prominent in this group. Misdiagnosis can have severe consequences for children and their families, including inadequate care, insufficient access to rehabilitation and stimulation, reduced accessibility to services and inappropriately limited opportunities for participation. The proposed project will develop and validate a diagnostic measure that supports detailed goal-planning—the Music therapy Sensory Instrument for Cognition, Consciousness and Awareness (MuSICCA).Methods and analysisFace validity will be assessed using a short questionnaire and the MuSICCA will be amended if face validity is insufficient. Once face validity is sufficient, 80 participants with suspected DOC will be recruited from multiple sites around the UK, USA and Ireland.Validity will be assessed using external reference standards (Coma Recovery Scale-Revised, Coma Near-Coma Scale and Nociception Coma Scale). Intra-rater reliability will be established using repeated ratings of video recordings from the assessment sessions. Inter-rater reliability will be assessed through video ratings by a second blinded assessor. In addition to these analyses, the clinical utility of the MuSICCA will be evaluated using a questionnaire to be completed by clinicians and relatives of the participants following the completion of the MuSICCA assessment.Ethics and disseminationEthical approval has been obtained for this study from the Research Ethics Committee and Health Research Authority of the National Health Service of the UK (ID: 167534). Results will be presented at national and international conferences, published in scientific journals and disseminated to participant representatives, clinicians, educators and care providers.Trial registration detailsThis study was registered at ClinicalTrials.gov Protocol Registration and Results System on 7th August 2019 (ID: NCT04050995); Pre-results.
Positive effects of music therapy for people with dementia and their family carers are reported in a growing number of studies. However, small sample sizes or low recruitment rates often limit the success of these research studies. More adequately powered evidence-based studies are needed to impact policy and funding in dementia care. This systematic review examined recruitment strategies in music therapy clinical trials involving people living with dementia and/or their family carers. Eligible studies described enrolment, consent, accrual, or recruitment methods as well as recruitment or consent rates. Thirty studies with a total of 1,192 participants were included. Recruitment and conversion rates in residential aged care facilities (RACFs) (14 studies) were substantially higher than in community-based studies (16 studies). Whereas studies in RACFs most commonly recruited participants through staff approaching residents face-to-face or conversing with residents’ legal guardians, community-based studies utilized a vast array of strategies, including staff referral, demonstrations/information sessions by researchers, advertisements, and direct contact with residents. Recruitment rates are likely to be higher when recruiters have an existing relationship with potential participants and when an independent third-party dementia organization is involved. Randomized controlled trials led to equally or greater recruitment conversion rates than other designs. Findings suggest that recruitment in dementia trials is complex, challenging, and needs thorough planning and consideration to be time- and cost-effective. Future studies should include reporting of recruitment strategies, enrolment rates, and related aspects so that researchers can better design recruitment strategies and estimate resources needed to reach the target sample size.
Background/Aims Relearning to walk is an important goal for many children and young people after acquired brain injury. Rhythmic auditory stimulation uses rhythm to support gait retraining. Its efficacy has been shown for adults with acquired brain injury and children and young people with cerebral palsy. No studies exist for children and young people with acquired brain injury. The aim of this pilot study was to investigate whether the addition of rhythmic auditory stimulation to standard physiotherapy improves children and young people's gait speed and quality after severe acquired brain injury. Methods Four children and young people (aged 10–13 years) with severe acquired brain injury accessing residential rehabilitation were recruited to a multiple baseline single case experimental design study, AB design. During baseline (A) phase children and young people accessed standard rehabilitation (10 physiotherapy sessions per week). In the intervention (B) phase, 2 out of the 10 standard physiotherapy sessions were replaced with rhythmic auditory stimulation. Length of baseline was randomised and intervention phases were 4 weeks. The 10 m walk test and Edinburgh Visual Gait Scale were completed pre and post sessions biweekly. Data analysis including visual analysis of level, slope and trend of the data will be presented with the results of a test of statistical significance. Results Data collection will finish in December 2018. Early results indicate that the quality of walking improved more during the intervention phase than the baseline phase for at least one of the participants, and rhythmic auditory stimulation was equal to normal physiotherapy in the other participants. Statistical testing is required. Conclusions Early results indicate that rhythmic auditory stimulation is at least as effective as normal physio in improving the walking quality of children and young people with acquired brain injury, but this needs to be confirmed. Recommendations for clinical practice and future studies can be made based on the findings and experience of this study.
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