Grappling with uncertainty - Experiences of parents of infants following perinatal stroke.

BACKGROUND: The term perinatal stroke describes focal damage to the developing brain due to cerebrovascular disease and occurring either before or shortly after birth. Aetiology, presentation and evolution differ from stroke in adults. AIMS: We aimed to explore early parental experiences related to having a child with perinatal stroke, including how parental psychological wellbeing had been impacted, to consider how support for families could be improved. METHODS AND PROCEDURES: We undertook a qualitative research study, using in-depth interviews of parents of infants with perinatal stroke when the infants were 5-6 months corrected gestational age. Sixteen parents (11 female, 5 male) of 11 infants with perinatal stroke took part. Thematic analysis was used in data interpretation. OUTCOMES AND RESULTS: Parents described distress related to the lack of information regarding likely outcome following perinatal stroke, as well as confusion around the term 'stroke'. Guilt and self-blame were expressed, with increased emotional sensitivity. Seeking information about stroke to reduce uncertainty was a useful strategy for some, but overwhelming for others. CONCLUSIONS AND IMPLICATIONS: The diagnosis of perinatal stroke led to psychological distress in parents. Uncertainty following diagnosis produced significant emotional difficulties. Recommendations for practice include providing timely, paced information and psychological support.

Can wrist-worn devices and a smartphone application influence arm activity in children with unilateral cerebral palsy? A proof-of-concept study.

Aim: To determine whether a wrist-worn triaxial accelerometer-based device and software (including smartphone application), incorporating feedback, is feasible, acceptable, and can lead to increased affected upper limb use during everyday activities in children with unilateral cerebral palsy (UCP). Methods: Study design: Mixed methods proof of concept study. Participants: Children aged 8-18 years with UCP; age-matched typically developing controls ("Buddies"), therapists. Intervention: Baseline (2 weeks): devices recorded arm activity. Active feedback (6 weeks): devices also gave vibratory prompts if affected arm activity fell below pre-set personalised thresholds (UCP group only; control group continued as per Baseline). Final 2 weeks: as baseline. Both groups accessed a smartphone application providing feedback on relative arm motion throughout the study. Assessment and analysis: ABILHAND-Kids questionnaires and MACS classifications captured baseline participant characteristics (UCP group). Accelerometer data was used to calculate relative arm activity (signal vector magnitude) corrected for time worn/day, and trends in relative arm activity examined using single case experimental design (both groups). In-depth interviews with families, "Buddies" and therapists assessed feasibility and acceptability of implementation. A framework approach was used for qualitative data analysis. Results: We recruited 19 participants with UCP; 19 buddies; and 7 therapists. Five participants (two with UCP) did not complete the study. Baseline mean (stdev) ABILHAND-Kids score of children with UCP who completed the study was 65.7 (16.2); modal MACS score was II.Qualitative analysis demonstrated acceptability and feasibility of the approach. Active therapist input for this group was minimal. Therapists appreciated the potential for summary patient data to inform management. Arm activity in children with UCP increased in the hour following a prompt (mean effect size z = 0.261) for the non-dominant hand, and the dominant hand (z = 0.247). However, a significant increase in affected arm activity between baseline and intervention periods was not demonstrated. Discussion: Children with UCP were prepared to wear the wristband devices for prolonged periods. Whilst arm activity increased bilaterally in the hour following a prompt, increases were not sustained. Delivery of the study during the COVID-19 pandemic may have negatively influenced findings. Technological challenges occurred but could be overcome. Future testing should incorporate structured therapy input.

Wrist-Worn devices to encourage affected upper limb movement in unilateral cerebral palsy: Participatory design workshops.

Background: Unilateral (Hemiplegic) cerebral palsy (UCP) causes weakness and stiffness affecting one sided of the body, often impacting activities of daily living. Upper limb therapy at effective intensity is not accessible to most. Aim: To determine stakeholder views on design of an approach using wrist-worn devices and a smartphone application to encourage use of the affected upper limb for children with hemiplegia. Method: Four participatory design workshops and one young people's advisory group workshop incorporating views of five young people with hemiplegia, 13 typically developing peers aged 8-18 years, four parents, three occupational therapists, one teacher and two paediatricians. Two special educational needs co-ordinators were consulted separately. Peers were included to explore a study design whereby each child with hemiplegia would have a participating "buddy". Topics included views on an acceptable wrist-worn device and smartphone application, participant age range, involvement of a buddy, and barriers to using the technology in a school setting. Ethical/welfare considerations included data security, and potential risks around providing smartphones to young children. Results: Children wanted a comfortable, conventional-appearing wristband incorporating a watch face and a secure, well-fitting strap. They were prepared to wear a band on each wrist. They wanted support with explaining the study to schoolteachers. Most schools restricted smartphone use during the school day: the study design accommodated this. Children agreed with a game as reward but had different views on an acceptable game; direct access to feedback data was preferred by some. Parents commented on the lack of access to upper limb therapy for children with UCP; therapists concurred. The proposed participant age range was widened based on feedback. Typically developing children were prepared to be buddies to help a friend with CP. Stakeholders were reassured by data security explanations and plans to provide internet safety information to participants. Conclusion: The participatory design process informed plans for the proof-of-concept stage of the study, hopefully leading to an approach that will be fun, easy to integrate into everyday life, and have the capacity to increase use of the affected arm and hand.

Participatory design in the development of an early therapy intervention for perinatal stroke.

BACKGROUND: Perinatal stroke is the leading cause of unilateral (hemiparetic) cerebral palsy, with life-long personal, social and financial consequences. Translational research findings indicate that early therapy intervention has the potential for significant improvements in long-term outcome in terms of motor function. By involving families and health professionals in the development and design stage, we aimed to produce a therapy intervention which they would engage with. METHODS: Nine parents of children with hemiparesis and fourteen health professionals involved in the care of infants with perinatal stroke took part in peer review and focus groups to discuss evolving therapy materials, with revisions made iteratively. The materials and approach were also discussed at a meeting of the London Child Stroke Research Reference Group. Focus group data were coded using Normalisation Process Theory constructs to explore potential barriers and facilitators to routine uptake of the intervention. RESULTS: We developed the Early Therapy in Perinatal Stroke (eTIPS) program - a parent-delivered, home-based complex intervention addressing a current gap in practice for infants in the first 6 months of life after unilateral perinatal stroke and with the aim of improving motor outcome. Parents and health professionals saw the intervention as different from usual practice, and valuable (high coherence). They were keen to engage (high cognitive participation). They considered the tasks for parents to be achievable (high collective action). They demonstrated trust in the approach and felt that parents would undertake the recommended activities (high collective action). They saw the approach as flexible and adaptable (high reflexive monitoring). Following suggestions made, we added a section on involving the extended family, and obtained funding for a website and videos to supplement written materials. CONCLUSIONS: Focus groups with parents and health professionals provided meaningful feedback to iteratively improve the intervention materials prior to embarking on a pilot study. The intervention has a high potential to normalize and become a routine part of parents' interactions with their child following unilateral perinatal stroke.

Publishing protocols for trials of complex interventions before trial completion - potential pitfalls, solutions and the need for public debate.

BACKGROUND: Open Science is 'the movement to make scientific research, data and dissemination accessible to all levels of an inquiring society'. In the spirit of the Open Science movement, advance publication of protocols for clinical trials is now being advocated by BioMed Central, BMJ Open and others. Simultaneously, participants are becoming increasingly active in their pursuit and sharing of trial- and health- related information. Whilst access to protocols alongside published trial findings has clear benefits, advance publication of trial protocols is potentially problematic for trials of complex behavioural interventions. In this article we explain, with examples, how this could lead to unblinding, 'contamination' between intervention and control groups and deliberate biasing of assessment outcomes by participants. We discuss potential solutions and demonstrate the need for public debate about how this issue is best managed. CONCLUSION: Triallists may still be underestimating participants' interest in information. This needs to change: joint and open discussions with the public are needed to inform how we should proceed.