4 Sites, Finland

Fascial Manipulation in Cerebral Palsy Rehabilitation

Introduction Fascial manipulation (FM) is a manual therapy method developed by physiotherapist Luigi Stecco. It involves the treatment of deep fascia related to muscles or superficial fascia of subcutaneous tissue, which is made up of connective tissue. The goal of FM is to normalize the function of muscle-related fascia, allowing movement to return to normal and overstrained or painful structures to heal. Superficial fascial treatment is needed, for example, in the treatment of surgical scars and swelling The method has been used to treat various musculoskeletal disorders, with evidence supporting its effectiveness. FM can be used in the rehabilitation of children with CP (cerebral palsy) to treat stiffness caused by the non-neural component of spasticity. Both neural and non-neural factors influence the abnormal movement patterns caused by spasticity in children with CP. Recent research suggests that non-neural factors are functionally more significant. Spasticity caused by upper motor neuron damage leads to an increase in the extracellular matrix (ECM) of the muscle. The main component of the extracellular matrix is hyaluronan (HA), which facilitates internal muscle and intermuscular sliding and myofascial force transmission. The mechanical properties of the muscle, such as stiffness and viscosity, often change with spasticity, as the increased concentration of HA associated with spasticity can increase the viscosity of the ECM and the collagen content in the muscle. This affects both active and passive movement and alters the force production and coordination between agonist and antagonist muscles. Increased resistance to active movement causes fatigue and pain. Increased ECM viscosity increases the stretch on the perimysium and the muscle spindle attached to it, sensitizing spindle activation. These non-neural peripheral factors are believed to cause muscle stiffness. There have been few studies on the effectiveness of FM in the rehabilitation of children with CP. The limited studies and practical observations suggest that treatment targeting muscle-related fascia may be a beneficial addition to the rehabilitation of children with CP. High-quality studies on the effectiveness of FM in general musculoskeletal rehabilitation are scarce. A recent systematic review indicates that the level of evidence for FM is low to moderate. A systematic review on children with CP has recently been published. In Finland, the rehabilitation of children with CP has largely relied on the NDT/Bobath framework, although its effectiveness has been strongly criticized in a recent meta-analysis. The need for further research is evident. Therapists trained in NDT/Bobath use their experience, reflection, and knowledge gained from various continuing education courses in their work. The NDT-Bobath approach serves as the framework for clinical decision-making in therapy. It emphasizes the importance of the child's own activity in the development of agency. Research Objectives The aim is that the therapy method used in the study will provide additional benefits to the rehabilitation of children with CP by enabling better movement patterns, more effective training, and more economical movement, thereby enhancing the child's/youth's functional capacity. The indication for fascia manipulation is to prevent and correct the typical functional limitations caused by CP and to enable better functional capacity. Based on clinical observations, the acute effect of FM on the movement of children with CP is promising. The aim of this study is to investigate the acute and longer-term effects of FM using objective methods. The researchers will conduct an eight-week randomized and controlled rehabilitation intervention study with children with CP, comparing the effect of FM on walking ability and lower limb joint movements to therapy conducted according to current best rehabilitation practices. Through an interview study (with parents after the intervention), the researchers will investigate the potential added value of FM in the participant's involvement and empowerment, i.e., the ability to participate more diversely in various social activities and cope with hobbies, school, and other community activities. The assumption is that movement will be less strenuous. An interview with the child's own physiotherapist after the fascia manipulation intervention aims to identify any changes in functional capacity and therapy situations observed by the physiotherapist. The Gross Motor Function Classification Scale (GMFCS) is used to determine the severity of the motor impairment in children with CP, describing gross motor function, i.e., movement. The classification uses levels 1-5 (Terveyskylä, Lastentalo, CP-vamma lapsella). The target group for this study are children at GMFCS level 2 (independent walking without assistive devices, often requiring orthoses, with some difficulty moving outside the home, e.g., stairs) and GMFCS level 3 (independent walking with assistive devices, such as a walker or rollator, with significant difficulty moving outside the home, often using a wheelchair outdoors). Hypotheses: I) Acute Effect: Compared to conventional neurological physiotherapy, fascia manipulation more effectively reduces spasticity and stiffness in the ankle and other lower limb joints and decreases co-contraction of the extensor-flexor muscles of the ankle during walking. Participants will include those in GMFCS levels 2 and 3. They rarely have differentiated movement in the ankle, so any changes will be visible in the movements of the knee and hip. II) Longitudinal Effect: Compared to conventional neurological physiotherapy, fascia manipulation treatment better promotes the function of lower limb joints, which is reflected in an improved walking pattern (Gait Deviation Index) and positive changes in walking performance (6-minute walk test, primary outcome measure) and efficiency (oxygen consumption). III) Improved mobility increases and eases patients' participation in various activities outside the home, such as attending school and engaging in hobbies, and transitions in these situations Study Design and Patient Recruitment The researchers will conduct an 8-week randomized and controlled rehabilitation intervention study, recruiting 20 children aged 7-14 years with a diagnosis of spastic CP (GMFCS levels 2-3) . The participants will be recruited from the HUS/ULS patient registry. Sample Size and Randomization Power calculations were performed based on the primary outcome measure (6-minute walk test). Based on clinical observations, the researchers estimate that FM increases walking speed by approximately 10% (0.05 m/s), which corresponds to an improvement of about 60 meters in the 6-minute walk test. With an effect size of 0.8, the required sample size would be 15 (power = 90% and α = 0.05), but the researchers are accounting for a 25% dropout rate and will recruit a total of 20 children with CP. Participants will be randomized into two groups of 10: 1) fascia manipulation group (intervention group I) and 2) conventional physiotherapy group (intervention group II). Randomization will be done in blocks of four based on age, gender, GMFCS level, and baseline walking ability (6-minute test) and walking pattern (Gait Deviation Index). Once a group of four participants is formed based on registry data, they will be contacted, and both the child and the guardian will be asked about their willingness to participate in the study. If the child and guardian are willing to participate, the participants will be assigned to groups using a computer-based randomization tool, distributing 2-4 participants (considering GMFCS level, age, gender, and 6-minute walk test result) to intervention group I and intervention group II. If the child or guardian declines, a new participant will be sought using registry data (considering age, gender, and severity of CP), and their willingness to participate in the study will be asked. This process will continue until the intervention groups are formed. The study is prepared to increase the sample size by an additional 10 (5+5) patients if necessary. The decision will be made after 20 (10+10) patients have been studied and the interventions have been carried out. If there is attrition or other issues that complicate statistical analysis, the sample size will be increased. Intervention Group I In Intervention Group I, children will undergo motion analysis measurements at the beginning of the study, receive one fascia manipulation treatment, and then have the measurements repeated after the treatment to assess the acute response to the therapy. The group will receive 8 FM intervention treatments (once a week) either at the child's home or at the physiotherapist's office. The therapy intervention will last about two months. After the treatments, the children will undergo motion analysis measurements again to assess the longitudinal effect of the therapy. It is noteworthy that during the fascia manipulation treatment, the regular weekly physiotherapy based on stretching will continue. Intervention Group II In Intervention Group II, children will undergo initial measurements, after which the physiotherapist will guide them through stretching exercises, and final measurements will be taken to assess the acute response to the stretching. During the two-month intervention, the children will receive the same therapy as before (traditional physiotherapy) and, in addition, a remotely conducted stretching program guided by the physiotherapist. Thus, the children will receive physiotherapy twice a week. This arrangement is to more reliably assess the potential added value of fascia manipulation. After the two-month intervention, the children in Intervention Group II will undergo the same motion analysis measurements as at the beginning, and then Intervention Group II will receive FM therapy eight times. The duration of the intervention is about two months. A semi-structured interview will be conducted with the relative (parent) of the participant after the fascia manipulation intervention. A total of about 10 parents will be interviewed. The aim of the qualitative study is to document the impact of FM on the participant's daily life, schooling, social participation, and the effects on the lives of the participant's parents. The study will also interview the participant's physiotherapist (a total of about 10). The researcher will contact the interviewee to arrange a suitable time. The interview can be conducted either via Teams remote connection or face-to-face. The interview will last about 30 minutes. The interviews will be recorded if the interviewees give their consent. The recorded interviews will be transcribed anonymously, and personal data will not be linked to the anonymized data.

Tailored Treatment of Insomnia in Social and Health Care Sector Shift Workers in Occupational Health Care

Disturbed sleep and insomnia are common among shift workers, and disturbed sleep is considered a key factor in other health risks associated with shift work. However, there are no established treatment practices for treating insomnia in shift workers. This study aims to evaluate the effectiveness of Cognitive-Behavioural Therapy for Insomnia (CBT-I) tailored for social and health care sector shift workers whose work includes night shifts. Furthermore, the study will assess the shift workers' experiences of the acceptability and feasibility of CBT-I from their perspective. The study will also examine which features of shift work and employee characteristics promote or interfere with the effectiveness of the tailored CBT-I. The study is a randomised controlled trial. Participants will be shift workers in the social and health care sector who work in three or two shifts, including night shifts, and have significant insomnia symptoms. Participants will be recruited through occupational health services (OHS) and social media posts. The FIOH study group will carry out the measurements of the participants. Participants will complete the baseline measures (sleep diary, actigraphy and questionnaires) and then will be randomly assigned to receive the research intervention (CBT-I tailored to the shift work context; six individual sessions) or the control intervention (sleep hygiene counselling; one individual session). The interventions will be delivered by the nurses of the participants´ OHS and the FIOH. Participants will complete the follow-up measures after the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment. The results of the study can be utilised in OHS to guide and treat shift workers with insomnia as part of supporting their work ability.

CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)

Efficacy of Music-Based Telerehabilitation After Stroke

ReDirection / Self-Guided ICBT to Reduce the Risk of Child Sexual Abuse Material (CSAM) Use

Photodynamic Treatment in the Management of Residual Biofilm - a Crossover Study

The antimicrobial effect of aPDT is based on the principle that light as such activates a non-toxic, photosensitive molecule, generating reactive oxygen species that kill the bacterium. Applications of aPDT in dentistry include the treatment of bacterial and fungal infections and the diagnosis of lesions. In dental treatment, regular photodynamic treatment with dual-light has been shown to be beneficial for the gingival health of dental implants and to reduce the amount of visible plaque (VPI). Photodynamic treatment has also been shown to slow down the amount of biofilm re-forming in the mouth. The simultaneous use of blue light and near-infrared light operating at 810 nm and 405 nm has been shown to reduce Staphylococcus aureus more effectively than using only a single light source. The use of indocyanine green as a photosensitizer in dual-light phototherapy has also been shown to be effective in eliminating Streptococcus oralis. Indocyanine green has otherwise low toxicity to dental restorative materials and to non-target host tissue. Indocyanine green is also very suitable as a photosensitizer due to its high absorption peak. Indocyanine green-mediated photodynamic therapy as an adjunct to non-surgical periodontal treatment has been shown to improve treatment outcomes for dental adhesive tissue diseases with statistically significant results at 3 months and 6 months after treatment with periodontitis patients. There is in vitro evidence for the efficacy of indocyanine green specifically against periodontal pathogens. Tooth decay, gingivitis and periodontitis are common oral infections associated with tooth extraction and are caused by bacteria living in the mouth. In total, more than 500 different species of bacteria can be found in the mouth. The normal flora of a healthy mouth is rich in a variety of microbes that start to multiply from birth. Bacteria of different species form biofilms, or plaques (bacterial communities), on the tooth surfaces, some of which mutate to become pro-inflammatory. Most oral diseases are multifactorial. A high-sugar diet, poor oral hygiene, general diseases, dry mouth, ill-fitting dentures or antimicrobial therapy can affect the microbial balance in the mouth and thus contribute to the development of oral diseases. Locally, oral areas are affected by possible plaque overgrowth, orthodontic appliances, open caries deposits and partially erupted wisdom teeth, which provide an easy attachment site for bacterial pathogens and a challenging area to clean. As biofilm accumulates at the gum line over several days, it causes the tissue to release inflammatory neurotransmitters that call on defense cells from the bloodstream to destroy bacteria. Inflammation of the gums appears as swelling, redness and bleeding on cleaning. If gingivitis becomes chronic, it is a risk for periodontitis, which is the inflammation and tissue destruction of the attachment tissues. Periodontitis is manifested in the mouth as inflammation of the attachment tissues, with deepening of the gum pockets around the tooth, increased tooth mobility, and alveolar leakage on X-rays. Careful, daily self-care and regular dental hygiene are the most important preventive measures for oral and jaw infections and dental infections. The surface of the tooth does not clean itself like the surface of the mucous membrane or skin through natural taming, so it must be cleaned mechanically. It is recommended to brush the teeth twice a day for two minutes with fluoride toothpaste and to brush the interdental spaces every 24 hours with a suitable instrument. Lumoral® is a powerful LED light device with a mouthpiece operating blue light at 405 nm and near-infrared light at 810 nm. The Lumoral® treatment involves a combination of the use of mouth rinse inculding indocyanine green , Lumorinse®, and the Lumoral® dual-light mouthpiece. A tablet of Lumorinse® is dissolved in 30 millilitres of water to form a mouthwash, which is swished around the oral cavity for 60 seconds. After using the mouthwash, the Lu-moral® mouthpiece is placed in the mouth for 10 minutes of light activation. After use, the teeth are cleaned by brushing and cleaning the interdental spaces. The active photosensitive substance of Lumorinse® adheres to the surface of the dental plaque, and the targeted light from the mouthpiece produces an antibacterial effect in the mouth. Lumoral® does not cause bacterial resistance, making it suitable for regular use. The treatment is bacterio-selective, meaning that it targets only harmful microbes in the mouth and does not affect the normal oral flora. The purpose of this study is to investigate the amount of residual biofilm by comparing conventional tooth cleaning with the additional cleaning of teeth with Lumoral®. The aim is to determine whether Lumoral® treatment reduces the amount of residual biofilm in the mouth in adults in general good oral health.

The Effect of Daratumumab in Patients with Monoclonal Gammopathy of Renal Significance (MGRS) in Finland

Intervention Effectiveness Study of BEtter AT LEarning (BEATLE)- Digital Neuropsychological Rehabilitation Program

BEATLE (BEtter AT LEarning) is a neuropsychological digital rehabilitative program (Digital Care Pathway, DCP) developed at the Department of Phoniatrics, University Hospital of Helsinki and Uusimaa region (HUS). The purpose of this DCP is to provide knowledge on meta-skills and tools for learning to 12-16-year-olds who experience learning difficulties due to developmental language disorder, dyslexia, or other developmental issues. The aforementioned developmental disorders can have long-lasting impacts on individuals' lives. For instance, children with DLD have been reported to have a lower quality of life than typically developing children, according to parent evaluations. Self-evaluation is a crucial aspect of individual performance and well-being. Albert Bandura's social cognitive theory posits that individuals are proactive and reflective beings who simultaneously shape and are shaped by their environment (Reciprocal Determinism). According to Bandura, individuals constantly evaluate and form beliefs about their capabilities to perform in given situations (Self-efficacy). The theory of self-efficacy is often employed in educational sciences, where students with higher self-efficacy beliefs have been found to exert more effort in schoolwork, perform better academically, and have a more positive attitude toward school. Primary school students with specific learning difficulties have been reported to have lower self-efficacy beliefs than their peers. Another perspective on self-evaluation and perception of difficulties can be explored through the concept of self-compassion. Neff defines self-compassion as a multifaceted construct that encompasses how individuals emotionally respond to suffering, cognitively understand their predicament, and pay attention to their suffering. A longitudinal study found that ninth-grade students with low self-esteem but high self-compassion exhibited better psychological health one year later compared to those with low self-compassion. Self-compassion has demonstrated its utility as a framework for interventions. The aim of BEATLE is to provide understanding, inspiration, and tools for better learning in adolescents. This study aims to (1) analyze the effectiveness and feasibility of the BEATLE online rehabilitative course in three clinical groups (DLD, Dyslexia, and Mixed Specific Developmental Disorder) and (2) explore the potential differences in effectiveness among these diagnostic groups. For example, participants with dyslexia may report better and more lasting outcomes than participants with DLD or Mixed Specific Developmental Disorder, considering that the DCP includes several strategies for using digital tools such as dictation and text-to-speech, which can aid with primary difficulties related to reading and writing. The study will employ a randomized controlled trial with a waitlist design. The objective is to assess potential changes in perceived self-efficacy, self-compassion, executive functioning, and attitudes toward learning as reported by participants, guardians (parents), and teachers. Additionally, this study aims to examine the correlation between the usage of the DCP and its effectiveness. Participants will be recruited from 12-16-year-old patients referred to HUS Phoniatrics or HUS Pediatric Neurology. The target sample size is 52 participants per group (26 in the intervention group and 26 in the waitlist group), totaling 156 complete participants. Accounting for a conservative dropout rate of 50%, up to 312 participants may be required for recruitment. Another digital health program (DHP) on acquired brain injury patients in adults has reported a dropout rate of approximately 20%. Recruitment will be conducted by neuropsychologists at respective clinics. After expressing willingness to participate, participants and their guardians will sign consent forms. Participants will then receive an envelope containing study materials and a consent form for their teacher to sign. Participation in the study does not supersede any other treatment. Signed consent forms will be submitted to the research team, after which participants will be randomized into either the intervention group or the waitlist group. Randomization will be conducted in RedCap to minimize the risk of bias. Participants in the intervention group will receive an invitation to the DCP a few days after signing the agreement and completing the pre-intervention questionnaires. Participants in the waitlist group will first complete baseline questionnaires and will then wait 10 weeks before entering the cross-over phase and receiving access to the DCP.

A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)

Stroke in Working Age and Job Accommodation in Facilitating Transition Back to Work

Introduction: Strokes are one of the most significant conditions affecting cognition among working-age adults. Incidence of stroke increases in older age and due to the lengthening of working careers, more people are experiencing strokes while still employed. Additionally, the incidence of strokes among younger workers has increased over recent decades. In Finland, 2000 - 3000 work-aged persons suffer a stroke annually. The majority experiences cognitive or emotional symptoms post-stroke, and for about half of them, these symptoms become long-lasting or permanent. The cognitive demands of modern work have steadily increased, and the severity of cognitive symptoms has been shown to strongly predict the likelihood of returning to work after a stroke. While job accommodation has been shown to be an effective way to support return to work after many illnesses, there is limited research on its benefits following a stroke. Furthermore, there is lack of research on cognitive job accommodation, despite health professionals finding it particularly challenging. Aims: To evaluate the effect of job accommodations after stroke on various work and health related outcomes. In addition, information about working-aged stroke patients returning to work and the practices of job accommodation is provided. In the future these results can potentially be applied also to other conditions affecting cognition. Participants and methods: This study will recruit 18-68 year old stroke patients who are returning to work (n ≈ 100). Participants will be randomized into either a job accommodation intervention group or a control group. The study will assess the benefits of cognitive job accommodation in terms of absenteeism, presenteeism, work modifications, perceived work ability, health indicators and cognitive and emotional symptoms. Participants will be followed through web-based surveys and novel cognitive tests over a 12-month period. The study will adopt a multidisciplinary approach (ergonomics, occupational psychology, neuropsychology, and medicine) and will be based on the International Classification of Functioning, Disability, and Health (ICF) model. Cognitive job accommodation will utilize an established model, a design form, and an instructional video. Collaborators and target organizations: The research will be conducted in collaboration with the Helsinki University Hospital Neurocenter and the Finnish Institute of Occupational Health. In addition to these organizations the study is funded by the Finnish Work Environment Fund. The target organizations include occupational health services and workplaces of stroke survivors. Utilization of Results: The methods developed in this study can be used in future collaborations between workplaces, occupational health services, and specialized healthcare. The findings can also be applied to other conditions that cause cognitive difficulties and require job accommodation.