Task-specific training versus usual care to improve upper limb function after stroke: the "Task-AT Home" randomised controlled trial protocol.

Background: Sixty percent of people have non-functional arms 6 months after stroke. More effective treatments are needed. Cochrane Reviews show low-quality evidence that task-specific training improves upper limb function. Our feasibility trial showed 56 h of task-specific training over 6 weeks resulted in an increase of a median 6 points on the Action Research Arm test (ARAT), demonstrating the need for more definitive evidence from a larger randomised controlled trial. Task-AT Home is a two-arm, assessor-blinded, multicentre randomised, controlled study, conducted in the home setting. Aim: The objective is to determine whether task-specific training is a more effective treatment than usual care, for improving upper limb function, amount of upper limb use, and health related quality of life at 6 weeks and 6 months after intervention commencement. Our primary hypothesis is that upper limb function will achieve a ≥ 5 point improvement on the ARAT in the task-specific training group compared to the usual care group, after 6 weeks of intervention. Methods: Participants living at home, with remaining upper limb deficit, are recruited at 3 months after stroke from sites in NSW and Victoria, Australia. Following baseline assessment, participants are randomised to 6 weeks of either task-specific or usual care intervention, stratified for upper limb function based on the ARAT score. The task-specific group receive 14 h of therapist-led task-specific training plus 42 h of guided self-practice. The primary outcome measure is the ARAT at 6 weeks. Secondary measures include the Motor Activity Log (MAL) at 6 weeks and the ARAT, MAL and EQ5D-5 L at 6 months. Assessments occur at baseline, after 6 weeks of intervention, and at 6 months after intervention commencement. Analysis will be intention to treat using a generalised linear mixed model to report estimated mean differences in scores between the two groups at each timepoint with 95% confidence interval and value of p. Discussion: If the task-specific home-based training programme is more effective than usual care in improving arm function, implementation of the programme into clinical practice would potentially lead to improvements in upper limb function and quality of life for people with stroke. Clinical Trial Registration: ANZCTR.org.au/ACTRN12617001631392p.aspx.

A single-case experimental evaluation of a new group-based intervention to enhance adjustment to life with acquired brain injury: VaLiANT (valued living after neurological trauma).

Adjustment to life with acquired brain injury (ABI) requires self-identity and behaviour to be updated, incorporating injury-related changes. Identifying and enabling new values-consistent behaviours could facilitate this process. We evaluated the feasibility, acceptability, and preliminary efficacy of VaLiANT, a new group intervention that aims to enhance "valued living" following ABI. We used a non-concurrent multiple baseline single-case experimental design (SCED) with an 8-week follow-up phase and randomization to multiple baseline lengths (5-7 weeks). Eight participants (50% women, aged 26-65; 4 Stroke, 3 Traumatic Brain Injury, 1 Epilepsy) attended eight group sessions with assessments before, during, and after the group. Target behaviour was valued living, assessed weekly by the Valued Living Questionnaire. Secondary outcomes included measures of wellbeing, mood, psychological acceptance, self-efficacy regarding ABI consequences, cognitive complaints, and intervention acceptability. Target behaviour was analysed through visual and statistical analysis while secondary outcome data were analysed via reliable change indices and descriptive statistics. Target behaviour data displayed no convincing patterns of improvement. Reliable improvements were found for most participants on secondary outcomes, particularly subjective wellbeing and anxiety. Intervention delivery was feasible with high acceptability ratings. Further investigation of VaLiANT is warranted, based on the feasibility and acceptability of intervention delivery and signals of efficacy identified across adjustment-related secondary outcomes.

Investigating feasibility and preliminary efficacy of a simulator-based driving intervention for people with acquired brain injury: A randomised controlled pilot study.

OBJECTIVE: To investigate the feasibility and preliminary efficacy of a driving simulator intervention on driving outcomes following acquired brain injury. DESIGN: Pilot randomised controlled trial. SETTING: Occupational therapy driver assessment and rehabilitation service. SUBJECTS: Individuals post-acquired brain injury aiming to return to driving. INTERVENTION: Eight sessions of simulated driver training over four weeks, in addition to usual care. Control: Usual care only. MAIN MEASURES: Feasibility outcomes: Participant recruitment and retention; data completeness; therapy attendance and fidelity; adverse events. Performance outcomes: on-road driving performance; Simulator Sickness Questionnaire; Brain Injury Driving Self-Awareness Measure and Driving Comfort Scale - Daytime, assessed at baseline and five weeks post-randomisation. RESULTS: Out of 523 individuals screened, 22 (4%) were recruited and randomised, with 20 completing their allocated group (n = 12 Simulator, n = 8 Usual Care). For those who completed training, session attendance was 100% with simulator sickness rated, on average, as mild. Six individuals (50%) in the Simulator group failed the on-road assessment, versus two (25%) in the Usual Care group (P = 0.373). On average, the Simulator group reported a positive change in confidence ratings (M = 5.77, SD = 13.96) compared to the Usual Care group, who reported a negative change (M = -6.97, SD = 8.47), P = 0.034. The Simulator group (M = 0.67, SD = 3.34) demonstrated no significant change in self-awareness relative to the Usual Care group (M = -0.83, SD = 1.83, P = 0.325). CONCLUSIONS: With adjustments to inclusion criteria and recruitment strategies, it may be feasible to deliver the intervention and conduct a larger trial. There is potential benefit of simulator training for improving driver confidence after acquired brain injury.

Does Integrating Cognitive and Psychological Interventions Enhance Wellbeing After Acquired Brain Injury? Study Protocol for a Phase II Randomized Controlled Trial of the VaLiANT (Valued Living After Neurological Trauma) Group Program.

Background and Objectives: Cognitive and emotional changes affect the majority of individuals with acquired brain injury (ABI) and are associated with poorer outcomes. The evidence for "siloed" rehabilitation approaches targeting cognition and mood separately remains mixed. Valued living (i.e., acting consistently with personal values) is associated with better psychological functioning and participation in work and other productive activities. Rehabilitation interventions that concurrently address cognitive and emotional barriers to valued living may therefore result in improved outcomes. VaLiANT (Valued Living After Neurological Trauma) is an 8-week group intervention developed by our team, which uniquely combines cognitive rehabilitation and psychological therapy to improve wellbeing and meaningful participation (i.e., valued living) following ABI. Method: This protocol describes the design and implementation of a Phase II parallel-group randomized controlled trial with blinded outcome assessors, to evaluate the potential efficacy of VaLiANT and the feasibility of a Phase III trial. Participants are adults with a history of ABI at least 3 months prior to study entry, who experience cognitive and/or emotional difficulties and associated reduced participation in valued activities. Random allocation to the treatment condition (8-week VaLiANT group program) or a usual care waitlist control condition occurs at a 2:1 treatment: control ratio. The primary outcome is wellbeing, measured by the Warwick-Edinburgh Mental Wellbeing Scale. Secondary outcomes include measures of valued living, mood, cognitive complaints, quality of life, community participation, post-traumatic growth, and self-efficacy. All measures are collected across three time points by blinded assessors (baseline, 8-week follow-up, 16-week follow-up). Trial feasibility will be evaluated against recruitment rates, drop-out rates, intervention acceptability, and treatment fidelity (manual adherence and therapist competence). Discussion: This trial will extend current knowledge on how to improve long-term outcomes following ABI by evaluating an innovative integrated, multi-domain approach to rehabilitation concurrently addressing cognitive and emotional barriers to participation in meaningful life roles.

The development of a simulator-based intervention to rehabilitate driving skills in people with acquired brain injury.

PURPOSE: With little to guide researchers and clinicians on how best to develop driving simulator interventions for ABI survivors, we aimed to describe the development process of a driving simulator intervention for ABI survivors in a rehabilitation setting. METHOD: Intervention mapping methodology was used as a framework for the development of our driving simulator intervention. A qualitative synthesis of theoretical and empirical literature and stakeholder meetings enabled identification of factors affecting return to driving, selection of justifiable intervention goals, and identification of appropriate theoretically-informed techniques to facilitate change. These were used as a basis for design of intervention components and materials. A plan for delivery, implementation and evaluation was then developed. RESULTS: Determinants of driving ability, including knowledge and skills, self-efficacy, self-awareness of driving skills, awareness of risk and compensatory strategies were identified. These were applied to a range of tactical and operational driving behaviours to identify targets for change. Theoretically-informed strategies included direct instruction, repetition, graded difficulty, feedback and tailoring. An eight-session protocol, with a corresponding clinical manual, was developed for brain-injured patients who were referred for occupational therapy driving assessment. Protocols for recruitment, inclusion/exclusion criteria and facilitator training were developed, as well as a plan for evaluating feasibility, acceptability and effectiveness. CONCLUSIONS: Intervention mapping was a useful approach to systematically develop an intervention tailored to the rehabilitation hospital context to complement existing driver rehabilitation. The feasibility and effectiveness of the simulator programme developed in this study will be evaluated in future studies.IMPLICATIONS FOR REHABILITATIONWe were able to gather important information and provide recommendations to tailor a new driving simulator intervention for individuals with acquired brain injury within a rehabilitation service.The processes and methods described provide researchers and clinicians with a systematic process for the selection of driving simulator intervention components and delivery.This investigation can be used to educate rehabilitation clinicians and technicians to improve driver training and delivery to acquired brain injury survivors.

User experiences and perspectives of a driving simulator intervention for individuals with acquired brain injury: A qualitative study.

Driving a motor vehicle is a common rehabilitation goal following acquired brain injury (ABI). There is increasing interest in the use of driving simulators for driver rehabilitation post-ABI; however, there is still limited research demonstrating efficacy and acceptability. This study sought to examine the user experience of a driving simulator intervention for ABI survivors. Semi-structured interviews were conducted with 14 individuals, including 12 ABI survivors (42% male; Mean age = 53.92 years, SD age = 17.63) who completed the intervention, and 2 occupational therapist driver assessors who facilitated the intervention. Thematic analysis was adopted to analyse interview data. Findings suggest that individual differences (e.g., anxiety, previous experience) influenced participant response to training. The intervention allowed participants to practise various driving skills, re-familiarize themselves with the task of driving, and prepare for return to on-road driving within a safe environment. The intervention was perceived to be useful for enhancing driver self-awareness, autonomy, confidence and patience. Fidelity and simulator sickness were considered limitations of the simulator technology. Subjective accounts of the appropriateness of intervention components are also documented. Overall, the simulator intervention was reported to be a positive experience for participants. Themes emerging from this study can inform future driving simulator interventions for ABI survivors.

An assessment of the utility and functionality of wearable head impact sensors in Australian Football.

OBJECTIVES: To assess the utility and functionality of the X-Patch® as a measurement tool to study head impact exposure in Australian Football. Accuracy, precision, reliability and validity were examined. DESIGNS: Laboratory tests and prospective observational study. METHODS: Laboratory tests on X-Patch® were undertaken using an instrumented Hybrid III head and neck and linear impactor. Differences between X-Patch® and reference data were analysed. Australian Football players wore the X-Patch® devices and games were video-recorded. Video recordings were analysed qualitatively for head impact events and these were correlated with X-Patch® head acceleration events. Wearability of the X-Patch® was assessed using the Comfort Rating Scale for Wearable Computers. RESULTS: Laboratory head impacts, performed at multiple impact sites and velocities, identified significant correlations between headform-measured and device-measured kinematic parameters (p<0.05 for all). On average, the X-Patch®-recorded peak linear acceleration (PLA) was 17% greater than the reference PLA, 28% less for peak rotational acceleration (PRA) and 101% greater for the Head Injury Criterion (HIC). For video analysis, 118 head acceleration events (HAE) were included with PLA ≥30g across 53 players. Video recordings of X-Patch®-measured HAEs (PLA ≥30g) determined that 31.4% were direct head impacts, 9.3% were indirect impacts, 44.1% were unknown or unclear and 15.3% were neither direct nor indirect head impacts. The X-Patch® system was deemed wearable by 95-100% of respondents. CONCLUSIONS: This study reinforces evidence that use of the current X-Patch® devices should be limited to research only and in conjunction with video analysis.

SCAT3 changes from baseline and associations with X2 Patch measured head acceleration in amateur Australian football players.

OBJECTIVES: To investigate changes from baseline on SCAT3 as a result of football game exposure, and association with X2 Patch measured head acceleration events in amateur Australian footballers. DESIGN: Prospective cohort. METHODS: Peak linear acceleration (PLA) of the head (>10 g) was measured by wearable head acceleration sensor X2 Biosystems X-Patch in male (n=34) and female (n=19) Australian footballers. SCAT3 was administered at baseline (B) and post-game (PG). RESULTS: 1394 head acceleration events (HEA) >10 g were measured. Mean and median HEA PLA were recorded as 15.2 g (SD=9.2, range=10.0-115.8) and 12.4 g (IQR=11.0-15.6) respectively. No significant difference in median HEA PLA (g) was detected across gender (p=0.55), however, more HEAs were recorded in males (p=0.03). A greater number (p=0.004) and severity (p<0.001) of symptoms were reported PG than at B. No significant association between number of HEA or median PLA, and SCAT3 change scores (p>0.05 for all), was identified for either gender. CONCLUSIONS: Increase in symptom severity post game was not associated with X2 measured HEA. Males sustained more HEA, however HEA PLA magnitude did not differ across gender. Further work on the validation of head acceleration sensors is required and their role in sports concussion research and medical management.

Characterising Upper Limb Movements in Huntington's Disease and the Impact of Restricted Visual Cues.

BACKGROUND: Voluntary motor deficits are a common feature in Huntington's disease (HD), characterised by movement slowing and performance inaccuracies. This deficit may be exacerbated when visual cues are restricted. OBJECTIVE: To characterize the upper limb motor profile in HD with various levels of difficulty, with and without visual targets. METHODS: Nine premanifest HD (pre-HD), nine early symptomatic HD (symp-HD) and nine matched controls completed a motor task incorporating Fitts' law, a model of human movement enabling the quantification of movement timing, via the manipulation of task difficulty (i.e., target size, and distance between targets). The task required participants to make reciprocal movements under cued and blind conditions. Dwell times (time stationary between movements), speed, accuracy and variability of movements were compared between groups. RESULTS: Symp-HD showed significantly prolonged and less consistent movement times, compared with controls and pre-HD. Furthermore, movement planning and online control were significantly impaired in symp-HD, compared with controls and pre-HD, evidenced by prolonged dwell times and deceleration times. Speed and accuracy were comparable across groups, suggesting that group differences observed in movement time, variability, dwell time and deceleration time were evident over and above simple performance measures. The presence of cues resulted in greater movement time variability in symp-HD, compared with pre-HD and controls, suggesting that the deficit in movement consistency manifested only in response to targeted movements. CONCLUSIONS: Collectively, these findings provide evidence of a deficiency in both motor planning, particularly in relation to movement timing and online control, which became exacerbated as a function of task difficulty during symp-HD stages. These variables may provide a more sensitive measure of motor dysfunction than speed and/or accuracy alone in symp-HD.