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A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT).

ABSTRACT: BACKGROUND:An acquired brain injury (ABI) is a complex injury often followed by a broad range of cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities, vocational rehabilitation (VR) is a challenging task, however, of great importance, since approximately 75% of the patients with ABI are of working age. Thus, standardized clinically effective and cost-effective methodologies regarding VR for patients with ABI are highly needed. Therefore, the aim of this study is to evaluate the effect of an individually targeted manual-based VR for patient with ABI compared to conventional VR (usual care). METHODS:This study is an interventional, two-arm, six-month follow-up, cluster randomized controlled trial involving four municipalities in the Zealand Region and the Capital Region of Denmark. A total of 84 patients with ABI evenly distributed across four municipalities will be included in the study. The patients will randomly be allocated in a 1:1 ratio to the VR intervention provided by a specialized Brain Injury Centre or the conventional VR provided by the municipalities (usual care). The six- to nine-month intervention will consist of individual and group therapies as well as a work placement program including supported employment. Furthermore, the intervention will include a family intervention program followed up by support to one individual family caregiver. The primary outcomes are increased work or study rate at six-month follow-up. Moreover, a budget impact analysis and possibly a cost-utility analysis of the intervention will be performed. DISCUSSION:This study consists of a comprehensive multidiciplinary VR intervention involving several parties such as the municipalities, a specialized rehabilitation team, and patients' own family caregivers. If this intervention is proven successful when compared to the conventional VR, it will provide evidence for a manual-based individualized holistic approach in returning to work after an ABI. Furthermore, the study will contribute with novel knowledge regarding feasibility and clinical effectiveness of the VR intervention relevant to clinicians, researchers, and policymakers. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03086031 . Registered on 21 March 2017.

SUBMITTER: Hoeffding LK

PROVIDER: S-EPMC5550982 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT).

Hoeffding Louise K LK Nielsen Maria Haahr MH Rasmussen Morten A MA Norup Anne A Arango-Lasprilla Juan Carlos JC Kjær Ulrikka K UK Burgdorf Kristoffer Sølvsten KS Quas Kirsten Jensen KJ Schow Trine T

Trials 20170810 1

<h4>Background</h4>An acquired brain injury (ABI) is a complex injury often followed by a broad range of cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities, vocational rehabilitation (VR) is a challenging task, however, of great importance, since approximately 75% of the patients with ABI are of working age. Thus, standardized clinically effective and cost-effective methodologies regarding VR for patients with ABI are highly needed. Therefore, the aim of t ...[more]

PMID: 28793916

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Project description:BackgroundSwallowing impairment (dysphagia) following brain injury can lead to life-threatening complications such as dehydration, aspiration pneumonia and acute choking episodes. In adult therapeutic practice, there is research and clinical evidence to support the use of swallowing exercises to improve swallowing physiology in dysphagia; however, the use of these exercises in treating children with dysphagia is largely unexplored. Fundamental questions remain regarding the feasibility and effectiveness of using swallowing exercises with children. This review aims to outline the published literature on exercise-based treatment methods used in the rehabilitation of dysphagia secondary to an acquired brain injury across the lifespan. This will allow the range and effects of interventions utilised to be mapped alongside differential practices between adult and child populations to be formally documented, providing the potential for discussions with clinicians about which rehabilitative interventions might be appropriate for further trial in paediatrics.MethodsThis study will use a scoping review framework to identify and systematically review the existing literature using Joanna Briggs Institute (JBI) and Preferred Reporting Items for Systematic Reviews (PRISMA) scoping review guidelines. Electronic databases (MEDLINE, PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine Database (AMED)), grey literature and the reference lists of key texts including systematic reviews will be searched. Information about the rehabilitation design, dosage and intensity of exercise programmes used as well as demographic information such as the age of participants and aetiology of dysphagia will be extracted. The number of articles in each area and the type of data source will be presented in a written and visual format. Comparison between the literature in adult and child populations will be discussed.DiscussionThis review is unique as it directly compares dysphagia rehabilitation in adults with that of a paediatric population in order to formally identify and discuss the therapeutic gaps in child dysphagia rehabilitation. The results will inform the next stage of research, looking into the current UK-based speech and language therapy practices when working with children with acquired dysphagia.Systematic review registrationOpen science framework osf.io/ja4dr.

Project description:ObjectivesEstablishment of effective evidence-based interventions in rehabilitation of working memory (WM) deficits after acquired brain injury (ABI) is sorely needed. Despite robust evidence for the efficiency of clinical hypnosis in a wide range of clinical conditions, and improved understanding of mechanisms underlying its effects, the potential of clinical hypnosis in cognitive rehabilitation is underexplored. A recent study has shown large effects of hypnotic suggestion on WM capacity following ABI. This randomized controlled trial aims to evaluate and explore the replicability of these findings and examine the generalization of treatment effects. The study will also explore possible mechanisms of change.MethodsNinety patients will be recruited from the Sunnaas Rehabilitation Hospital. Inclusion criteria are nonprogressive ABI, minimum 12-month post-injury, ongoing WM deficits, and age between 18 and 67 years. Patients will be randomized to either (a) an intervention group receiving four weekly 1-h sessions with induction and hypnosis, (b) an active control group receiving four weekly 1-h sessions of induction and mindfulness, or (c) a passive control group without intervention. The targeted procedure consists of suggestions about enhancing WM functions, for example through the instantiation of preinjury WM capacity in the present using age regression or through visualizations of brain plasticity. The non-targeted suggestions contain no explicit mention of ABI- or WM-related abilities. Each participant will be assessed at baseline, immediately after intervention, and 6 months after baseline. The primary outcome is the WM index from WAIS-IV and self- and informant-reported WM subscale from BRIEF-A, a questionnaire exploring executive functioning in everyday life. Secondary outcomes include a cognitive composite score derived from tests measuring processing speed, executive functions, learning capacity and memory, and self-reported measures of emotional distress, quality of life, and community integration. Exploratory measures include self-rated ABI and WM-related self-efficacy.DiscussionRehabilitation of impaired WM after ABI has hitherto yielded limited transfer effects beyond the training material, i.e., improvement effects on everyday WM capacity, and clinical trials of new interventions are thus warranted. Long-standing empirical evidence demonstrates that hypnosis is an effective therapeutic technique in a wide range of conditions, and recent exploratory research has suggested a high efficacy of hypnosis in improving WM capacity in patients with ABI. However, these extraordinary findings need replication in studies applying scientifically rigorous designs. If successful, our ambition is to provide recommendations and materials to implement hypnotic suggestion as an adjunct treatment following ABI. Study findings may inform future studies exploring the use of clinical hypnosis in other areas of rehabilitation, such as mild TBI, and in other neurological conditions where WM deficit is prominent.Trial registrationClinicalTrials.gov NCT05287542. Registered on March 2022 PROTOCOL VERSION: Protocol version 2.0, December 2023.

Project description:BackgroundPediatric 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.MethodsChildren 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.DiscussionThe 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 registrationClinicalTrials.gov NCT04798859 . Registered on March 15, 2021.

Project description:Introduction:Chronic migraine is a largely refractory condition affecting between 1 and 2.2% of the overall population worldwide, with females more affected than males. There are also high health and socioeconomic costs associated both for the individual and society. The mainstay of chronic migraine management is pharmacological, but the options available have limited efficacy and there are often unwanted side effects. There is some evidence for manual therapy as a treatment option for migraine, but its effectiveness for chronic migraine is unknown. Therefore, we have designed a pragmatic randomised control trial to investigate whether adding manual therapy to the tertiary specialist treatment of chronic migraine improves patient-reported outcomes. Methods:A pragmatic, randomised controlled trial in a hospital tertiary headache clinic. Participants will be randomised into one of two groups: treatment as usual or treatment as usual plus manual therapy. The primary outcome measure will be a change in the Headache Impact Test score. Secondary outcomes will also be measured over the 12-week study period including changes in headache frequency, migraine specific quality of life and reductions in relevant medicine consumption. The manual therapy group will have five treatment sessions each lasting 30?min. The recruitment target of 64 participants will allow power at 80% with p?=?0.05 using minimal clinical difference for Headache Impact Test of 3.7 and includes provision for a 10% dropout rate. Recruitment will take place between August 2018 and February 2019. The results will form part of a doctoral study and be published in peer-reviewed journals and presented at national/international conferences. Discussion:Current pharmacological approaches have limited effects in the management of chronic migraine and there is a requirement to improve treatment options and reduce the health and economic burden of the condition. Manual therapy has been shown to be effective in other chronic pain conditions as well as other primary headaches. This study will explore the effectiveness of manual therapy as an adjunctive approach to the management of chronic migraine. Trial registration:The trial has received a favourable opinion from the UK Health Research Authority (IRAS 228901) and is registered at ClinicalTrials.gov.number NCT03395457. Registered 1st March 2018.

Dataset Information

A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT).

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A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT).

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