Clinical Research Directory

Local Vibration for Drooling in Children With Cerebral Palsy

This randomized-controlled trial evaluates local vibration therapy for drooling and orofacial muscle biomechanics in children with cerebral palsy. Participants receive either local vibration plus conventional physiotherapy or sham vibration plus conventional physiotherapy.

Association Between Extremity Muscle Strength and Functional Outcomes in Children With Cerebral Palsy

The aim of this study was to evaluate whether upper and lower extremity muscle strength is a factor in activity, participation and quality of life parameters in school-age children with CP and to reveal the difference in upper and lower extremity muscle strength compared to typically developing peers.

Ayres Sensory Integration Intervention for Children With Cerebral Palsy

This study will examine whether a 12-week Ayres Sensory Integration (ASI)-based physiotherapy program can improve motor skills and daily functioning in young children with cerebral palsy. Thirty children aged 3 to 6 years who meet the study criteria will be assigned to an intervention group or a control group. Children in the intervention group will receive 36 sessions of ASI-based physiotherapy over 12 weeks. Each session will last 60 minutes and will be provided by a physiotherapist certified in ASI. Children in the control group will continue their usual physiotherapy and rehabilitation and will not receive additional ASI as part of the study. Children will be assessed before and after the 12-week study period. Assessments will include measures of motor skills, development, daily activities, sensory processing, and progress toward individual goals. The Evaluation in Ayres Sensory Integration (EASI) will be completed before the intervention only. Assessments will be carried out in a clinical setting by an assessor who is independent of the therapists providing the intervention.

Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy

This pilot study aims to evaluate the immediate, short-term biomechanical and neuromuscular effects of lower limb manual therapy applied as a preparatory phase prior to functional neuromotor rehabilitation in children with spastic cerebral palsy (hemiplegic and diplegic forms). Using a prospective self-controlled design, 20 children will be assessed under four experimental conditions (baseline, post-manual therapy, post-functional therapy, and post-combined manual + functional therapy) to determine if manual techniques enhance gait parameters and motor execution.

Impact of rTMS Combined With Neurorehabilitation on Lower Extremity Motor Function and Spasticity in Children With Spastic Diplegic Cerebral Palsy

Cerebral palsy (CP) is widely recognized as the most prevalent cause of lifelong physical disability emerging in childhood across most global populations. While international data typically reports a prevalence ranging from 1.5 to 2.5 per 1,000 live births, in our specific national context, this rate is notably higher, reaching 4.4 per 1,000. CP is defined as a heterogeneous group of permanent disorders that fundamentally disrupt the development of movement and posture. These disruptions lead to significant activity limitations and are attributed to non-progressive disturbances occurring in the developing fetal or infant brain. Beyond primary motor impairments, CP is frequently characterized by a complex constellation of associated symptoms, including sensory and perceptual deficits, cognitive impairments, communication difficulties, behavioral challenges, epilepsy, and secondary musculoskeletal complications that develop over time.Among the various clinical presentations, diplegic CP stands out as the most common subtype of spastic CP, with prematurity identified as the leading etiological factor. In children diagnosed with spastic diplegia, all four extremities are typically involved; however, the clinical hallmark of this subtype is that the lower extremities are significantly more affected than the upper extremities. Despite this lower-body dominance, a loss of fine motor skills is frequently observed in the upper extremities as well. Most children with spastic diplegia face the risk of becoming significantly disabled due to these combined symptoms, a situation that exerts a profound and lasting impact on the quality of life for both the child and their entire family.This complex clinical picture underscores the critical importance of implementing a comprehensive and multidisciplinary CP rehabilitation program. Such programs must be initiated as early as possible, tailored to the child's specific age and functional status, and maintained throughout their entire lifespan. The planning of CP rehabilitation requires a highly individualized approach based on the unique needs of each patient. The ultimate and primary goal of these interventions is to facilitate the child's full participation in social life while maintaining the minimum possible level of physical and functional disability.In contemporary CP rehabilitation, a wide array of therapeutic modalities is employed. These include neurophysiological exercises, conventional physical therapy, gait training, orthotics, assistive devices, and pharmacological spasticity management. Furthermore, occupational therapy, cognitive rehabilitation, speech and swallowing therapy, hydrotherapy, and advanced robotic treatments-such as virtual reality applications and balance-training devices-are integrated into the patient's care plan. Functional Electrical Stimulation (FES), including specialized applications like FES cycling, and visual rehabilitation are also prescribed according to individual requirements.In addition to these traditional methods, recent research in pediatric neurology has increasingly focused on the efficacy of Non-Invasive Brain Stimulation (NIBS) for various pediatric neurological disorders. For any therapeutic modality to demonstrate a truly effective and long-lasting impact, it must influence the brain's neuroplasticity over the long term. Theoretically, treatment methods that act directly on the cerebral cortex or specific neuronal populations may support nervous system development and correct dysfunction more effectively than traditional "bottom-up" approaches. While traditional methods rely on remodeling the central nervous system through peripheral organ stimulation, NIBS offers a "top-down" regulatory mechanism.One of the most promising novel diagnostic and therapeutic options in CP management is Transcranial Magnetic Stimulation (TMS), a specific form of NIBS that has shown effectiveness in improving clinical outcomes for children. The fundamental objective of TMS is to stimulate neurons in targeted cortical regions and their associated networks through an intact skull using a magnetic coil. This technology modulates neuronal activity patterns: it achieves an inhibitory effect when applied at low frequencies (1-5 Hz) or an excitatory effect at high frequencies (5-20 Hz), thereby aiming to restore a healthy neuronal balance in the brain.Extensive clinical studies indicate that repetitive TMS (rTMS) can significantly improve motor function, reduce spasticity, enhance balance control, and even improve speech functions in CP patients. Although the relatively limited number of pediatric studies sometimes leads to hesitation regarding safety, current clinical evidence suggests that rTMS is a safe and well-tolerated intervention for children with CP. No serious adverse events have been reported in pediatric rTMS trials to date. Rare side effects, when they occur, are typically transient and mild, including minor headaches, neck pain, scalp

Focused Versus Radial Extracorporeal Shock Wave Therapy on Gastrocnemius Spasticity in Children With Spastic Quadriplegic Cerebral Palsy

The goal of this pilot randomized controlled trial is to compare the effectiveness of focused extracorporeal shockwave therapy (ESWT) versus radial ESWT on gastrocnemius spasticity in children with spastic quadriplegic cerebral palsy (CP). The main questions it aims to answer are: 1. Does focused ESWT (fESWT) reduce gastrocnemius spasticity more effectively than radial ESWT (rESWT)? 2. Are the antispastic effects of fESWT more durable over time compared with rESWT? Researchers will compare: * fESWT group (one session weekly, 4 weeks) * rESWT group (one session weekly, 4 weeks) to see if fESWT more effective to lower Modified Ashworth Scale (MAS) scores during all assessment time points compared with rESWT. Participants will: * Be randomly assigned to either fESWT or rESWT group. * Receive one treatment session per week for 4 consecutive weeks. * Undergo MAS score evaluations at: baseline, post-intervention weeks 1-4, and follow-up at 4, 8, and 12 weeks after the final treatment.

Effects and Feasibility of a HABIT-ILE and a Home Program on the Bimanual Performance of Children With Cerebral Palsy

This single arm double baseline study explored the efficacy and feasibility of the PARTNER program (30h HABIT-ILE + 10h home program) on the functional changes and families' resources of 14 children with unilateral CP aged 24 to 71 months.

Effect Of Brain Gym Exercises On Balance And Quality Of Life In Children With Spastic Diplegia

Statement of the problem Do brain gym exercises affect balance and quality of life in children with spastic diplegia? Null hypotheses: 1. There will be no significant effect of brain gym exercises on balance in children with spastic diplegia. 2. There will be no significant effect of brain gym exercises on quality of life in children with spastic diplegia.

Intelligent Physiological Monitoring to Predict Preterm Brain Injury

Cerebral palsy (CP) remains prevalent among very (28-31 weeks) and extremely (\<28 weeks) preterm infants. Prematurity-related brain injuries (high-grade intraventricular haemorrhage, IVH or periventricular leukomalacia, PVL) develop usually during the first few days after birth and are a strong predictor of CP. Development of IVH or PVL have been linked to hemodynamic instability. Artificial intelligence (AI) provides an opportunity to detect patterns from continuous physiological monitoring data that are associated with prematurity-related brain injury. A dataset of extremely preterm infants will be collated from previous INFANT Research Centre study cohorts. A separate but aligned anonymous dataset will be obtained from the University of Graz. Continuous physiological monitoring data will be analyzed with AI algorithms to identify infants with the highest risk of brain injury.

The Effect of Hip Joint Orthotic Intervention and Conventional Exercise Training on Spasticity, Balance and Walking Performance in Children With Cerebral Palsy

Cerebral palsy (SP) is defined as a group of persistent disorders that cause activity limitation of movement and postural development. Children with cerebral palsy are typically born with a normal anatomical hip sequence. The incidence of hip dysplasia reported in patients with cerebral palsy ranges from 2% to 75%. Various non-surgical measures have been used to prevent or slow the progression of spastic hip dysplasia. The therapy program should include activities designed to sustain hip movement and promote weight bearing. However, there is no convincing evidence that treatment alone prevents hip subluxation. To prevent the progression of hip dysplasia, the physical therapy program should include activities designed to increase the functionality of the buttocks and promote weight bearing. In our study, standing strategies will be applied as conventional therapy. Orthotizing, corrective dynamic elastomeric fabric orthoses and taping applications are often used to prevent hip dysplasia. In our study, TheraTogs orthotic garment part, auxiliary dynamic belt material supporting muscles Tog-Rite will be used.Tog-Rite with a width of 7 cm will be made by applying approximately 50-60% stretch with spiral winding from the hip to the bottom of the knee. Positioning will be taught to families and instructed to wear 4 hours a day. Reminders will be made via remote weekly message, families will be able to reach the therapist at any time. Conventional therapy will continue for 2 sessions per week, 45 minutes in a clinical setting. T0: initial assessment, T1: 3ay conventional therapy, T3: 3 months of conventional therapy + positioning with spasticity, balance and impact on walking will be examined. Socia-demographic information forms of the children taken to the study will be recorded. According to the Gross Motor Function Classification System, children of the GMFCS I- II- III level will be taken to work. Children's independence levels will be determined and recorded with the Functional Independence Measure (WeeFIM). Muscle tone will be assessed by the Modified Ashworth Scale. The Pediatric Berg Balance Scale will be applied for functional balance. Balance measurement will be done with the Becure Balance System. Assessment of the gait will be done through the Gillette functional assessment questionnaire. The walking speed will be done with a 10 meter walking test.

Acceptability of Paediatric Wrist Orthoses Through Co-design

The goal of this pilot interventional study (pre-post design) is to learn if a co-designed wrist-hand orthosis can improve acceptability compared to a conventional orthosis in children aged 6 to 14 years with neuromotor disorders following acquired or congenital brain injury. The main questions it aims to answer are: Does a wrist-hand orthosis developed through a co-design process with the pediatric patient show greater acceptability - measured via the Technological Acceptance Measure (TAM-3) - compared to the conventional orthosis already used by the patient? Does the co-designed orthosis guarantee at least equivalent functional performance to the conventional orthosis, as assessed through upper limb kinematic analysis? Researchers will compare the co-designed orthosis to the conventional orthosis to see if the co-design and personalization process improves acceptance, satisfaction, and functional outcomes. Participants will: Complete acceptance and satisfaction questionnaires (TAM-3 and QUEST 2.1) and undergo functional upper limb assessment while wearing their conventional orthosis Participate in two structured co-design workshops (\~1.5 hours each) involving creative and expressive activities to define preferences for their personalized orthosis Receive and wear the co-designed 3D-printed orthosis, then repeat functional assessments and questionnaires, and take part in a semi-structured interview about their co-design experience.

Core Stability Exercises vs Hippotherapy for Spastic Cerebral Palsy

Cerebral palsy is associated with impaired balance and trunk control, which affect functional mobility and independence. This randomized clinical trial compares the effects of core stability exercises versus hippotherapy, both combined with conventional physiotherapy, on balance and trunk control in children with spastic cerebral palsy. The findings aim to determine which intervention provides greater improvement in functional outcomes.

Concurrent tDCS for Chronic Pain in Adults With Cerebral Palsy

The purpose of this study is to find out whether combining transcranial direct current stimulation (tDCS) using the Starstim tES8 device with motor-based activities, such as action observation or motor imagery (chosen based on task-fMRI results showing activation in the primary motor cortex), is a feasible treatment for chronic pain.

Effects of Circuit Training and Task Oriented Training on Balance and Quality of Life in Children With Spastic Diplegic Cerebral Palsy

Cerebral palsy (CP) is a group of permanent disorders affecting movement and posture, caused by non-progressive disturbances in the developing fetal or infant brain. Circuit training and task-oriented training are two emerging approaches in pediatric rehabilitation. Circuit training focuses on structured exercises performed in sequence to improve strength, agility, and balance, while task-oriented training emphasizes repetitive practice of meaningful, functional activities relevant to daily life.

Effects of Fun-Core (Child-Friendly Core Stabilization) Exercises on Balance and Functional Mobility in Children With Spastic Cerebral Palsy

A total of 54 children, aged between 6 and 12 years, diagnosed with hemiplegic cerebral palsy and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, between June 1, 2025 and March 1, 2026, were planned to be included in our thesis study, which was planned to be prospective, randomized and single-blind. Children and their parents will be informed verbally and in writing about the study's purpose, duration, and method of implementation, and their informed consent will be obtained. They will be asked to sign an "Informed Consent Form." Patient assessment and follow-up forms will be completed at pre- and post-treatment follow-ups. Patients who meet the inclusion criteria will be numbered according to their order of admission and then randomly assigned to either the intervention or control groups by a computer program. In addition to a brochure showing the number of sets and repetitions to be given to the patients as a standard home exercise program, the Fun-Core video exercise program, designed as a child-friendly core stabilization exercise program to be performed 3 times a week, will be given to the intervention group (G1), and the exercises will be delivered to the participants through a website with special accounts. The control group (G2) will receive a standard home exercise program in brochure format, showing the number of sets and repetitions. The exercise program will be performed at home three times a week for 8 weeks.

Epidemiology of Sleep Disordered Breathing in Children and Young People With Cerebral Palsy

Cerebral palsy (CP) refers to a non-progressive movement disorder, which occurs due to damage to the developing brain around the time of birth. Symptoms of sleep disordered breathing (SDB) include noisy breathing during sleep,increased day-time sleepiness and reduced energy levels. In the long term, SDB might have an effect on the brain and learning, as well as putting strain on the heart. Children with CP have a higher risk of sleep breathing problems compared to typically-developing children, and the negative impact of sleep disturbance in children with CP on their family members/carers' sleep and mental health cannot be understated. Early recognition and management of SDB is important for children with CP to give these children the best possible sleep quality, and to maximise learning potential. SDB in children with CP is often under-recognised and under-treated. Treatment of SDB in children with CP might involve wearing a mask that delivers pressurised air to hold open a child's airway and make breathing easier when they are asleep. This is called 'respiratory support' which can be continuous pressure (CPAP) or non-invasive ventilation (NIV) which is pressure support with a back-up breathing rate. There is limited knowledge on the appropriate indications or timing to use them. Though respiratory support in children with CP is proven to help with breathing during sleep, its impact on quality of life, number of hospital admissions or frequency of chest infections is unknown. This study will look at the number of children with CP on respiratory support across the UK, as well as the number of children newly diagnosed with SDB and/or established on respiratory support over a 1-year period. This study will also explore socioeconomic factors that might influence access of sleep services and the perceived facilitators and barriers to successfully initiating respiratory support in children with CP.

The Effect of Perturbation Training on Reactive Balance in Children With Cerebral Palsy

The aim of this project was to evaluate whether perturbation training influences reflex modulation in children with spastic CP and whether changed reflex modulation leads to improved reactive balance and walking. Reactive balance was trained using rotational perturbations. Reactive balance performance and reactive muscle activity during trained and untrained perturbation conditions were assessed in children with cerebral palsy and typically developing children.

Outcomes of Neurosurgical Tone Management

Patients with spastic/dystonic quadriplegia (GMFCS IV/V) are often severely disabled by their tone, and require surgical tone management to improve quality of life, allow for better function, improve comfort, and range of motion. This has historically been limited to Intrathecal Baclofen (ITB) pumps, which are effective for up to 85% of patients but carry significant morbidity / complications and are not appropriate for many patients. More recently, combined dorsal/ventral rhizotomy (CR) has emerged as an alternative means for tone control, a one-time surgery with no required hardware implantation. However, more information is needed regarding long-term outcomes of this procedure in addition to comparative outcomes of ITB. This information will lead to improved patient selection, counseling, and care. This is a prospectively enrolled, single-center study, involving survey administration and clinical observation of outcomes pre- and post-surgery.

Optimized AFO Care For Children With Cerebral Palsy.

Ankle-foot orthoses (AFOs) are widely prescribed in children with cerebral palsy (CP) to improve their gait, enhance mobility and prevent secondary complications during growth. However, in the Netherlands there is considerable variation in how AFO treatment is provided, and AFOs are not always optimally effective. In adults with neuromuscular disorders, it has been proven that optimized orthotic care delivered according to a standardized protocol reduces practice variation and is more effective in achieving individual treatment goals and improving patient satisfaction than usual orthotic care. For children with CP, it is expected that orthotic care based on a similarly standardized and optimized approach, will support better decision-making regarding the most appropriate orthosis and improve the overall AFO care process. In addition, such an approach may reduce healthcare costs compared to current AFO care, for example by reducing the need for consultations with other healthcare professionals. The aim of this study is to develop a new approach to AFO treatment in children with CP. This will be done by developing a standardized protocol that provides guidelines and instructions for healthcare professionals on key aspects of AFO selection, user training and evaluation. First, the effects of current AFO care will be evaluated in a group of 43 children with CP. After development of the new optimized protocol, the effects of optimized AFO care will be evaluated in a second group of 43 children with CP. The investigators will compare the attaining of personal treatment goals at 3 months follow-up between optimized AFO care and usal AFO care, and assess the cost-effectiveness of both interventions.

Proprioceptive Neuromuscular Facilitation Versus Music Therapy in Ataxic Cerebral Palsy

This study will recruit eligible participants from the Physical Therapy Department of the University of Lahore Teaching Hospital, obtain informed consent, and randomly assign them by lottery into two groups, with the assessor kept blinded. Group A will receive PNF combined with conventional physiotherapy, involving 20-30-minute sessions three times a week, beginning with a warm-up, followed by PNF techniques such as rhythmic initiation, hold-relax, and slow reversals, and ending with a cool-down to enhance muscle tone, flexibility, and motor control. Group B will receive music therapy along with conventional physiotherapy in 30-minute sessions three times a week, incorporating warm-up sensory regulation, rhythmic auditory stimulation, instrument play, movement-to-music activities, and vocal exercises, concluding with calming music for relaxation. The interventions aim to improve motor coordination, communication, and overall functional outcomes in children with cerebral palsy.

Childhood Toxin Perception Survey

Context: Most medical and surgical interventions for individuals with Cerebral Palsy (CP)-such as botulinum toxin injections, orthopedic surgery, and rehabilitation-occur during childhood. While these treatments are costly and resource-intensive, there is a significant lack of long-term data regarding their effectiveness in adulthood. Furthermore, the perspective of adult patients on the care they received as children is rarely documented. Understanding this "patient-centered" perspective is vital, as care aligned with an individual's values is proven to result in higher satisfaction and better health outcomes. Problem Statement While botulinum toxin (BTX) has been the gold standard for treating focal spasticity since 2009, it is an iterative (repeated) treatment that can involve procedure-induced pain. At present, there is limited knowledge about how adults with CP perceive the long-term impact of childhood vaccinations. The emotional and physical burden of repeated treatments during development is also not well understood, as are the coping strategies developed by these individuals to manage the stress and pain associated with long-term medical care. Objectives The PERTOXE study is a prospective study designed to explore the transition from childhood care to adult life for individuals with CP. Its primary goals are: Perception of Care: To evaluate how adults with CP perceive the effectiveness and impact of the botulinum toxin injections they received during childhood. Lived Experience: To document the subjective experience of treatment, including induced pain and the quality of communication with healthcare providers. Coping Mechanisms: To explore the "coping strategies" these individuals use to face stressful medical events and chronic functional decline. Significance As the lifespan of individuals with CP increases, understanding long-term outcomes is a research priority. By collecting data from adults, this study aims to improve current pediatric practices, ensuring that childhood interventions better support a high quality of life, functional maintenance, and psychological well-being in adulthood.

Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting

The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program in a clinical setting. The secondary objective of the study focuses on obtaining preliminary data on the potential clinical and psychosocial benefits of the product.

Wearable Eye Tracking During Bimanual Tasks in Children With Cerebral Palsy

This observational pilot study will include 40 children and adolescents aged 6 to 12 years: 20 with cerebral palsy and 20 with typical development. The main purpose is to determine whether Pupil Labs Neon wearable eye-tracking glasses can be used reliably while participants perform structured tasks using both hands. Each participant will attend one study visit. After assessments of near vision, hand function, visual perception, visual-motor function, and attention-related characteristics, participants will wear the eye-tracking glasses. They will view an instruction card, find target objects, and place the objects into boxes using both hands. The tasks will be completed under three conditions that vary visual-search and sequencing demands, with breaks provided as needed. Researchers will evaluate whether the planned procedures can be completed and whether the recordings provide usable eye-tracking data. Exploratory analyses will examine how gaze and hand actions are coordinated and whether these patterns differ between the cerebral palsy and typical-development groups or across task conditions. No treatment will be provided, and the study is not designed to evaluate treatment effectiveness. The findings will be used to improve the measurement protocol and quality-control procedures for future research.

Targeted Muscle Activation During Strength Training for Children With CP

Cerebral palsy (CP) is the most common cause of physical disability in children and is associated with muscle weakness, spasticity, and impaired motor control. These impairments often lead to compensatory movement strategies, in which other muscles are recruited or movements are adapted to offload weaker target muscles. Although lower limb strengthening is widely used to improve motor function in children with CP, outcomes remain inconsistent. One potentially important but rarely examined factor is whether the intended muscles are actually activated during training. This study aims to develop and apply an activation-driven assessment protocol that combines individualized exercise selection, real-time electromyography (EMG) biofeedback, and compensation monitoring to identify conditions that promote target-muscle activation while limiting compensatory mechanisms. The focus is on three key muscle groups: hip extensors (HE), knee extensors (KE), and plantar flexors (PF). In this prospective\[JV2.1\], within-subject repeated-measures study, 30 ambulant children aged 5-12 years with spastic CP and Gross Motor Function Classification System levels I-III will complete three assessment visits in which exercise conditions and feedback strategies are compared using surface EMG and three-dimensional movement analysis.