BackgroundAcquiring a traumatic injury constitutes a severe life change for the survivor, but also for the surrounding family. The paradigm of helping the family has primarily been on psychosocial interventions targeting caregivers. However, interventions including both survivor and caregivers should be an essential part of treatment, as the whole family’s functional level and mental health can be affected. The current study protocol presents a manualized family intervention for families living with traumatic injury to the brain (TBI) or spinal cord (tSCI). The objectives are to investigate if the intervention improves quality of life (QoL) and decreases burden. It is hypothesized that the family intervention improves problem-solving strategies and family dynamics, which will reduce the burden. This may improve the caregivers’ mental health, which will improve the support to the survivor and QoL.MethodsThe study is an interventional, two-arm, randomized controlled trial. During a 2-year period, a total of 132 families will be included. Participants will be recruited from East-Denmark. Inclusion criteria are (1) TBI or tSCI, (2) ≥ 18 years of age, (3) ≥ 6 months to ≤ 2 years since discharge from hospital, (4) ability to understand and read Danish, (5) cognitive abilities that enable participation, and (6) a minimum of one family member actively involved in the survivor’s life. Exclusion criteria are (1) active substance abuse, (2) aphasia, (3) prior neurologic or psychiatric diagnose, and (4) history of violence. Within each disease group, families will be allocated randomly to participate in an intervention or a control group with a ratio 1:1. The intervention groups receive the family intervention consisting of eight sessions of 90 min duration. Families in the control groups receive 2 h of psychoeducation. All participants complete questionnaires on QoL, self-perceived burden, family dynamics, problem-solving strategies, mental health, and resilience at pre-intervention, post-intervention, and 6-month follow up.ConclusionIf the intervention is found to have effect, the study will contribute with novel knowledge on the use of a manual-based intervention including the entire family. This would be of clinical interest and would help families living with the consequences of TBI or tSCI.Trials registrationClinicalTrials.gov, NCT03814876. Retrospectively registered on 24 January 2019.

Although a control group is lacking, the evidence suggests that the positive improvement is a result of the combined visual and balance training. The combination of balance and visual training appears to facilitate changes at a multimodal level affecting several functions important in daily life.

Validated self-report measures of post-stroke fatigue are lacking. The Dutch Multifactor Fatigue Scale (DMFS) was translated into Danish, and response process evidence of validity was evaluated. DMFS consists of 38 Likert-rated items distributed on five subscales: Impact of fatigue (11 items), Signs and direct consequences of fatigue (9), Mental fatigue (7), Physical fatigue (6), and Coping with fatigue (5). Response processes to DMFS were investigated using a Three-Step Test-Interview (TSTI) protocol, and data were analyzed using Framework Analysis. Response processes were indexed on the following categories: (i) “congruent,” response processes were related to the subscale construct; (ii) “incongruent,” response processes were not related to the subscale construct; (iii) “ambiguous,” response processes were both congruent and incongruent or insufficient to evaluate congruency; and (iv) “confused,” participants did not understand the item. Nine adults were recruited consecutively 10–34 months post-stroke (median = 26.5) at an outpatient brain injury rehabilitation center in 2019 [five females, mean age = 55 years (SD = 6.3)]. Problematic items were defined as <50% of response processes being congruent with the intended construct. Of the 38 items, five problematic items were identified, including four items of Physical fatigue and one of Mental fatigue. In addition, seven items posed various response difficulties to some participants due to syntactic complexity, vague terms, a presupposition, and a double-barrelled statement. In conclusion, findings elucidate the interpretative processes involved in responding to DMFS post-stroke, strengthen the evidence base of validity, and guide revisions to mitigate potential problems in item performance.

BackgroundAn 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).MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT03086031. Registered on 21 March 2017.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2115-0) contains supplementary material, which is available to authorized users.

The three extracted components of MFIS proved clinically informative. The arousal component revealed particularly interesting results in studying fatigue. The correlation analysis shown at this component differs from cognitive and physical fatigue and describes another aspect of PSF, important in future treatment and research.