Clinical Research Directory

Immersive AOT: Multisensory Stimulation and Neurophysiological Correlates in Children With Cerebral Palsy and Typical Development - A Pilot Study

The discovery of the Mirror Neuron System (MNS) has promoted the development of rehabilitation techniques such as Action Observation Treatment (AOT) and Motor Imagery (MI). These are based on the principle that neural circuits active during execution, also activate during the observation or imagination of movements. These techniques have been found to be effective in several clinical populations including children with Cerebral Palsy (CP), the most common childhood-onset motor disorder. We hypothesize that a multimodal version of AOT, integrating not only visual stimuli (standard practice) but also auditory and tactile stimuli, could further enhance the activation of the MNS. In fact, everyday actions naturally involve multiple sensory channels, and evidence indicate that audio-visual action observation activates the MNS more intensely than visual stimuli alone, thus offering a potential improvement for CP rehabilitation. The primary aim of this observational pilot study, conducted at IRCCS Fondazione Stella Maris, is to verify whether a multisensory (=immersive) AO session - combining visual, auditory, and tactile stimuli - produces greater activation of the MNS, than a traditional session (visual AO alone). Neural correlates will be measured through high-density Electroencephalography (hdEEG), with a specific focus on the modulation of the sensorimotor mu rhythm. Twenty children and adolescents with CP, aged 7-25 years, and 20 typically developing (TD) aged-matched peers will be recruited in the study. The study also aims to assess the level of participants' attention during stimuli presentation through eye tracking, and to verify whether immersive AO can influence MI abilities, measured through specific tasks and questionnaires (i.e., Motor Imagery Questionnaire for Children (MIQ-C, aged 7-12) and the Motor Imagery Questionnaire - 3 (MIQ-3) for adolescent). In an initial phase of the study both questionnaires will be the validated in a separate sample of 120 TD Italian children and 120 Italian adolescents or adults. The absence of intellectual disability will be assessed using the age-appropriate version of Raven's Progressive Matrices test. Each participant will undergo two EEG sessions: the immersive session will consist of watching first-person videos accompanied by auditory stimuli consistent with the action and tactile stimuli provided by TouchDIVER Pro haptic gloves (Weart, CE-marked device), suitably adapted for the paediatric population. The traditional session will consist of watching videos without sounds or any tactile additional stimulus. The two sessions will be performed in a in random order. In both sessions, after the observation phase, participants will be asked to perform or imagine the same actions presented in the videos. During observation, eye movements and gaze behavior will be monitored using an eye tracking system. Throughout each session, cortical activity will be recorded using a 128-channel hdEEG net. The sessions will be video-recorded to accurately monitor participants motor behavior, response times, and compliance with the protocol. At the end of each EEG session, participants will be administered the MIQ-C or MIQ-3 questionnaire and a short task to assess MI abilities. In this task, participants will watch some of the videos previously used during the EEG session and will then be asked to imagine the same action. In this case, their imagery will be interrupted at specific time points, and they will be asked to select, from two images, the moment of the action corresponding to the point at which they were interrupted. Data analysis will examine within- and between-groups differences for the immersive AO vs the traditional AO. Correlation analysis will be also performed between neurophysiological data, attentional data, questionnaires, MI responses and standardized clinical assessments ( for the CP group), in order to understand how the participants' motor and cognitive abilities influence the activation of the circuits involved in the experimental tasks.

rTMS Treatment of Spasticity in Children With Cerebral Palsy/ Hemiplegia Due to ABI - a RCT

This RCT aims to investigate the effect of repetitive transcranial magnatic stimulation (rTMS) in treating children with hemiplegoc cerebral palsy. The study will measure any improvement in spasticity after using contra-lesional inhibitory rTMS follow by intensive limb training. Participants will attend a 10-day rTMS treatment sessions, follow by intensive training of the impaired limb. They will also undergo MRI scans before and after the treatment to investiagte the underlying neurophysiological mechanisms that lead to changes clinically by using TMS as well as MR-DKI. Researchers will compare the intervention group and the sham group to see if rTMS could result in improvement of participants' spasticity.

Evaluating the Impacts of a Single Session of Robot Assisted Gait Training With a Trexo

Early use of robotic gait trainers have shown many benefits, however why these benefits occur and how to maximize them is unknown. There are a few options for how a robotic gait trainer can be used, however, there is not much understanding of how these options impact rehabilitation and compensate for impairments. The investigators aim to evaluate the impacts of as single session of Trexo robotic gait training and the impact of different modes of the Trexo robotic gait trainer. The investigators will evaluate how the different settings impact things like physical activity, walking, brain activity, spasticity, and fatigue. Investigators will arrange for a familiarity and fitting session to start, so that study team members can fit the participant to the Trexo and so that participants can become familiar with the feeling of using the Trexo robotic gait trainer. After the initial fitting sessions, follow up sessions will be completed to evaluate different settings on the Trexo, for example in "endurance" mode (where the robot completes the movements for the participant) and in "strength" mode (where the robot requires some assistance from the participant). Investigators may also test different fitting settings, for example with and without the supportive seat in the Trexo. Only three visits are required (one fitting/familiarity session and two testing sessions), however participants and/or their families may choose to complete more testing sessions if they want to assess other aspects of the training. For example, if the first two testing sessions assessed physical activity, participants and their families may choose to return for further sessions to assess brain activity. The aim of the study is to determine how robot assisted gait training impacts rehabilitation and compensates for impairments, as well as to provide suggestions on how the robotic gait trainer might be improved or modified. This study is exploratory to find out more about how these robotic gait trainers, specifically the Trexo, impacts various aspects of rehabilitation.

Effect of Masgutova Neurosensorimotor Reflex Integration on Oro-Motor Functional Skills in Children With Cerebral

Cerebral palsy (CP) is a disorder of movement and/or posture caused by a non-progressive brain lesion that persists through the lifespan and has a prevalence of more than 2 per 1000 live births (Oskoui et al., 2013). It comprises a heterogeneous group of impairments that may also affect the oral motor functions needed for eating, drinking, swallowing, and articulation (Romano et al., 2017). Dysphagia is a swallowing problem that can influence the safety and efficiency of feeding. This may lead to inadequate nutritional status due to prolonged feeding times (Mishra et al., 2018), stress during mealtimes for the caregiver and/or the child, and impaired growth (Cousino and Hazen, 2013; Stevenson et al, 2006). Estimates of the prevalence of dysphagia in children with CP vary widely due to the different definitions and tools used, variability in severity of CP, and motor type. The prevalence ranges from 21% in a group of 1357 children with CP (Parkes et al., 2010), to 99% in a group of 166 severely affected children with intellectual impairment (Calis et al., 2008). Children with CP commonly have feeding disorders and dysphagia that in many instances place them at risk for aspiration with oral feeding, with potential pulmonary consequences. They also commonly have reduced nutrition/ hydration status and prolonged stressful mealtimes. The specific nature and severity of the swallowing problems may differ, at least to some degree, in relation to sensorimotor impairment, gross and fine motor limitations, and cognitive/ communication deficits. Children with generalized severe motor impairment (for 2 example, spastic quadriplegia) are likely to experience greater swallowing deficits (Calis et al., 2008; Parkes et al., 2010). Oropharyngeal dysphagia may be characterized by problems in any or all phases of swallowing (Arvedson et al., 2019). The oral cavity and pharynx are anatomically separate but functionally integrated, the two regions are involved in complex motor responses that include feeding, chewing, swallowing, speech, and respiration. The multiple sensory receptors that innervate these two regions provide the first link in reflexes that control muscles of the entire head, upper gastrointestinal tract, and airway. Most of the reflexes affect the diversity of muscles that compose the tongue, which is vital to all stages of feeding, and which continually affects the patency of the airway (Miller, 2002). The types of oral and pharyngeal problems that children with CP have include reduced lip closure, poor tongue function, tongue thrust, exaggerated bite reflex, tactile hypersensitivity, delayed swallow initiation, reduced pharyngeal motility and drooling. Impaired oral sensorimotor function can result in drooling that in turn results in impaired hydration (Santos et al., 2012). The Schedule for Oral Motor Assessment (SOMA) is an assessment tool developed for the objective assessment of oral motor function in infants, with proven reliability and validity clinical setting. The SOMA is an assessment tool designed for the objective evaluation of oral-motor functions in children, with proven reliability and validity in infants aged 8-24 months. For the 5 types of test diet, based on the cutting score after assessment in each category, subjects are classified into normal or abnormal oral-motor function groups (Reilly et al., 1995). Oral motor rehabilitation therapy in children with CP aims at reducing or eliminating swallowing disorders and promoting functional feeding (Novak et al., 2020). Some studies suggest that intervention with oral motor therapy (OMT) or oro-motor exercise (OME) has a beneficial effect on functional independence levels and improves the quality of life of patients with feeding and swallowing 3 disorder (FSD) (Sığan et al., 2013; Howe and Wang, 2013). The Masgutova Neurosensorimotor reflex integration (MNRI) Facial Reflex Integration course is directed to the specific primary reaction of facial reflexes and their integration with whole movement development and learning. It arises from the basic Neurosensorimotor Reflex Integration concept that addresses the enhancement of learning through developing movement