Evaluation of the Training in Early Detection for Early Intervention (TEDEI) e-learning course using Kirkpatrick's method.

BACKGROUND: Early intervention in cerebral palsy could improve motor outcome but is only possible following early identification of those affected. There is a need for training of healthcare professionals (HCPs) in early detection of atypical motor development. We developed a video-based e-learning course - Training in Early Detection for Early Intervention (TEDEI) - to address this need. We evaluated whether participation in the course improved knowledge and changed behaviour of HCPs. METHODS: Participants were 332 HCPs (38% physiotherapists, 35.8% occupational therapists), predominantly UK-based (83.7%). Analysis of training effects used mixed methods and followed Kirkpatrick's model, first assessing "Reaction" through a feedback questionnaire involving Likert scale and free text responses (n = 141). "Learning" was assessed through multiple choice questions (MCQs): all 332 HCPs completed a pre-course quiz of 6 MCQs followed by the course, then a 16 item post-course quiz including the 6 pre-course questions. "Behaviour" was assessed through in-depth qualitative interviewing of 23 participants. RESULTS: "Reaction": TEDEI was found to be effective, engaging and well structured. "Learning": Scores improved significantly between the pre-course and post-course quiz, median improvement 1/6 (z = 5.30, p < 0.001). HCPs also reported a perceived improvement in their knowledge, confidence and ability. "Behaviour": HCPs could see how TEDEI would improve their clinical practice through having an assessment framework, ways of working better with parents, and developing observational skills useful for tele-health assessments. CONCLUSION: Our brief e-learning course on early detection for early intervention was viewed positively, improved knowledge and showed potential for positive changes in practice. Kirkpatrick's model provided a useful framework for undertaking this evaluation.

Fifteen-minute consultation: Management of the upper limb in unilateral cerebral palsy.

Children with unilateral cerebral palsy (UCP) have complex health, education and social care needs. Delayed gross motor milestones are the most common presenting feature, and much of the early management focuses on gross motor skills and lower limb management. In later childhood, adolescence and adulthood, upper limb function has significant impact on activity, participation and independence. There is clear pathophysiological rationale and emerging clinical evidence that earlier intervention to improve upper limb function is beneficial. Whereas most children with UCP are managed in secondary care, it is recommended that the assessment and delivery of specialist intervention for the upper limb occurs at a regional centre.

Current Therapeutic Management of Perinatal Stroke with a Focus on the Upper Limb: A Cross-Sectional Survey of UK Physiotherapists and Occupational Therapists.

AIM: To determine current UK pediatric physiotherapist (PT) and occupational therapist (OT) management of perinatal stroke. DESIGN: Web-based cross-sectional survey. METHODS: Participants were members of the Association of Paediatric Chartered Physiotherapists and Occupational Therapists specialist section: children young people and families working with infants. Items covered prioritization of referrals, assessments, therapy approaches aimed at the upper limb, and parental support. RESULTS: 179 therapists responded. 87.2% of PTs and 63.0% of OTs managed infants with perinatal stroke. Infants with clinical signs of motor dysfunction at referral were prioritized for early initial assessment. The most frequently used assessments were the Alberta Infant Motor Scale (AIMS) and Bayley Scales of Infant Development (BSID). Of PTs and OTs, 41.9 and 40.0% used no standardized assessments. Frequently used therapy interventions were Bobath/Neurodevelopmental Therapy (NDT), positioning aids and passive movements. 88.1% of therapists would choose a bilateral rather than unilateral (affected side) therapy approach for infants with perinatal stroke aged up to 6 months. Of PTs and OTs, 56.9 and 57.1% provided psychological support to families. CONCLUSIONS: Assessment and provision of therapy services following perinatal stroke is variable. Increased use of standardized assessments and centralized data collection regarding service provision for high-risk infants is recommended.

Feasibility trial of an early therapy in perinatal stroke (eTIPS).

BACKGROUND: Perinatal stroke (PS) affects up to 1/2300 infants and frequently leads to unilateral cerebral palsy (UCP). Preterm-born infants affected by unilateral haemorrhagic parenchymal infarction (HPI) are also at risk of UCP. To date no standardised early therapy approach exists, yet early intervention could be highly effective, by positively influencing processes of activity-dependent plasticity within the developing nervous system including the corticospinal tract. Our aim was to test feasibility and acceptability of an "early Therapy In Perinatal Stroke" (eTIPS) intervention, aiming ultimately to improve motor outcome. METHODS: Design: Feasibility trial, North-East England, August 2015-September 2017. Participants were infants with PS or HPI, their carers and therapists. The intervention consisted of a parent-delivered lateralised therapy approach starting from term equivalent age and continuing until 6 months corrected age. The outcome measures were feasibility (recruitment and retention rates) and acceptability of the intervention (parental questionnaires including the Warwick-Edinburgh Mental Wellbeing Scale (WEBWMS), qualitative observations and in-depth interviews with parents and therapists). We also reviewed clinical imaging data and undertook assessments of motor function, including the Hand Assessment for Infants (HAI). Assessments were also piloted in typically developing (TD) infants, to provide further information on their ease of use and acceptability. RESULTS: Over a period of 18 months we screened 20 infants referred as PS/HPI: 14 met the inclusion criteria and 13 took part. At 6 months, 11 (85%) of those enrolled had completed the final assessment. Parents valued the intervention and found it acceptable and workable. There were no adverse events related to the intervention. We recruited 14 TD infants, one of whom died prior to undertaking any assessments and one of whom was subsequently found to have a condition affecting neurodevelopmental progress: thus, data for 12 TD infants was analysed to 6 months. The HAI was well tolerated by infants and highly valued by parents. Completion rates for the WEBWMS were high and did not suggest any adverse effect of engagement in eTIPS on parental mental wellbeing. CONCLUSION: The eTIPS intervention was feasible to deliver and acceptable to families. We plan to investigate efficacy in a multicentre randomised controlled trial. TRIAL REGISTRATION: ISRCTN12547427 (registration request submitted 28/05/2015; retrospectively registered, 30/09/2015).

The Tyneside Pegboard Test: development, validation, and observations in unilateral cerebral palsy.

AIM: The aims of this study were twofold: first, to develop and validate a timed test of unimanual and bimanual dexterity suitable for those with disability affecting hand function; second, to explore relationships between unimanual and bimanual completion times. METHOD: We developed the Tyneside Pegboard Test (TPT), an electronically timed test with three peg sizes, incorporating an asymmetrical bimanual task. Nine hundred and seventy-four participants (455 males, 519 females; age range 4-80y) provided normative data. Test-retest reliability and construct validity were assessed (50 adults: 14 males, 36 females; 15-73y) on two occasions 2 weeks apart. Bimanual and unimanual completion times were measured in 87 children (51 males, 36 females) with unilateral cerebral palsy (CP) and 498 individuals in a comparison group (238 males, 260 females; 5-15y). RESULTS: The comparison group showed an asymmetrical U-shaped relationship between completion times and age. Intraclass correlation coefficients ranged from 0.74 to 0.91, indicating moderate test-retest reliability. There was a negative relationship between average TPT bimanual times and Purdue pegboard bimanual scores (Spearman's rho -0.611, degrees of freedom 44, p<0.001). Children with unilateral CP had greater prolongation of bimanual than unimanual completion times compared with the comparison group (mean difference 20.31s, 95% confidence interval 18.13-22.49, p<0.001). INTERPRETATION: The TPT is accessible for those with impaired hand function. Children with unilateral CP demonstrated disproportionate bimanual deficits, even allowing for unimanual dexterity: this has implications for therapy. WHAT THIS PAPER ADDS: We developed an adapted, electronically timed 9-hole pegboard test. Our modifications facilitate use by those with disability affecting hand function. The test incorporates an asymmetrical bimanual task. Children with unilateral cerebral palsy showed disproportionate bimanual dexterity deficits even allowing for unimanual dexterity.

Determinants of parent-delivered therapy interventions in children with cerebral palsy: A qualitative synthesis and checklist.

INTRODUCTION: Parent-delivered therapy interventions for children with cerebral palsy can help achieve a sufficient therapy dose, improve parental mental well-being, and facilitate parent-child relationships creating a more relaxed familial environment. However, parent-delivered interventions may also lead to increased parental stress, guilt if the therapy is not delivered, and time constraints. The primary aim of this review was to gain a deeper understanding of the determinants of effective parent-delivered therapy interventions. METHOD: Searches were conducted in the following databases: Medline, PubMed, Scopus, Embase, CINAHL, and Cochrane. Studies had to meet the following inclusion criteria: descriptions of parent/health care professional/child experiences of parent-delivered therapy interventions for children and young people age 0-18 years with cerebral palsy, published in the English language between January 1989 and May 2017, with qualitative or mixed methods research design. The articles were critically appraised, then synthesized using a meta-ethnographic approach. RESULTS: A literature search identified 17 articles, which met the inclusion criteria. Three main themes were identified: (a) building trusting relationships, (b) enabling the parents to cope, and (c) for parents and health care professionals to see the intervention as a priority. Further synthesis presented three concepts identifying the important aspects of the interventions: empowerment, motivation, and relationships. CONCLUSIONS: The themes and concepts emerging from this qualitative synthesis can be addressed by specific points of action to support parent-delivered therapy interventions. We have summarized these in a checklist for use by intervention developers, health care professionals, and parents.

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.

Effect of parent-delivered action observation therapy on upper limb function in unilateral cerebral palsy: a randomized controlled trial.

AIM: To determine whether home-based, parent-delivered therapy comprising action observation (AO) and repeated practice (RP) improves upper limb function more than RP alone in children with unilateral cerebral palsy (UCP). DESIGN: single-blinded parallel-group randomized controlled trial with 1:1 allocation comparing AO+RP (intervention) with RP alone (control). RANDOMIZATION: computer-generated, with allocation concealment by opaque sequentially-numbered envelopes. SETTING: northern England, August 2011 to September 2013. PARTICIPANTS: 70 children with UCP; mean age 5.6 years (SD 2.1), 31 female. INTERVENTION: home-based activities were provided, tailored to interests and abilities. DURATION: 15 minutes/day, 5 days/week for 3 months. ASSESSMENTS: Assisting Hand Assessment (AHA; primary outcome measure), Melbourne Assessment 2 (MA2), and ABILHAND-Kids at baseline, 3 months, and 6 months. RESULTS: Outcome data was available at 3 months for 28 children in the AO+RP group and 31 controls, and at 6 months for 26 and 28 children respectively. There were no between-group differences in AHA, MA2, or ABILHAND-Kids at 3 or 6 months versus baseline (all p>0.05). Combined-group improvements (p<0.001), observed in AHA and MA2 at 3 months, were maintained at 6 months. ABILHAND-Kids also showed improvement at 3 months (p=0.003), maintained at 6 months. INTERPRETATION: Parent-delivered RP (with or without AO) improves upper limb function and could supplement therapist input.

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.

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.

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.

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.

Early intervention to improve hand function in hemiplegic cerebral palsy.

Children with hemiplegic cerebral palsy often have marked hand involvement with excessive thumb adduction and flexion and limited active wrist extension from infancy. Post-lesional aberrant plasticity can lead to progressive abnormalities of the developing motor system. Disturbances of somatosensory and visual function and developmental disregard contribute to difficulties with hand use. Progressive soft tissue and bony changes may occur, leading to contractures, which further limit function in a vicious cycle. Early intervention might help to break this cycle, however, the precise nature and appropriateness of the intervention must be carefully considered. Traditional approaches to the hemiplegic upper limb include medications and botulinum toxin injections to manage abnormalities of tone, and surgical interventions. Therapist input, including provision of orthoses, remains a mainstay although many therapies have not been well evaluated. There has been a recent increase in interventions for the hemiplegic upper limb, mostly aimed outside the period of infancy. These include trials of constraint-induced movement therapy (CIMT) and bimanual therapy as well as the use of virtual reality and robot-assisted therapy. In future, non-invasive brain stimulation may be combined with therapy. Interventions under investigation in the infant age group include modified CIMT and action observation therapy. A further approach which may be suited to the infant with thumb-in-palm deformity, but which requires evaluation, is the use of elastic taping. Enhanced cutaneous feedback through mechanical stimulation to the skin provided by the tape during movement has been postulated to modulate ongoing muscle activity. If effective, this would represent a low-cost, safe, widely applicable early intervention.