Clinical Research Directory

Dorsal Root Electrical Stimulation in Children With Cerebral Palsy

The goal of this clinical trial is to evaluate whether dorsal root electrical stimulation could reduce spasticity in children with cerebral palsy (CP).

Coaching, Learning, Empowerment in Cerebral Palsy - a 6-Week Integrated PT/OT Caregiver "Primer" Bootcamp for Infants Diagnosed With or at High Risk for Cerebral Palsy

This study focuses on the caregiver's knowledge, comfort, and confidence in interacting with and supporting their infant with Cerebral Palsy (CP) or at high risk for Cerebral Palsy. Four caregivers with their infants will be in one cohort to assess the benefits of group intervention. The intervention is delivered in a group, bootcamp-style educational format led by clinical team including pediatric physiatrist, physical therapist and occupational therapist.

Turkish Version of the Hammersmith Neonatal Neurological Examination (HNNE)

Infants at risk are defined as an infant with a history of adverse environmental and biological factors that may lead to neuromotor developmental problems. This group includes premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays due to various reasons. These babies are also monitored for cerebral palsy (CP). CP is the most common physical disability in childhood, with an incidence of 2.1 per 1000 births. CP encompasses a group of permanent impairments in movement and posture development resulting from injury to the developing brain. Thanks to preventive measures and advances in obstetric and neonatal care, the incidence and severity of CP are currently decreasing in some countries, and it is emphasized that recovery can be more rapid with the use of early diagnosis guidelines or protocols in follow-up units. Early detection and monitoring of infants in the community for CP is essential only with appropriate, valid, and reliable tools to minimize potential sequelae through the timely implementation of CP-specific interventions. International guidelines require monitoring of infants at high risk of CP. This follow-up should be conducted by an interdisciplinary team, including a neonatologist, pediatrician, pediatric neurologist, pediatric physiotherapist, speech-language-swallowing therapist, and special education specialist. Pediatric physiotherapists are an important part of this team for developmental follow-up and rehabilitation. The Hammersmith Neonatal Neurological Examination (HNNE) is a method developed by Dubowitz and used in both clinical and research neurological examinations of preterm and term infants, is the neonatal form of the Hammersmith Infant Neurological Examination (HINE). Its use in the Neonatal Intensive Care Unit (NICU) is crucial for beginning risk assessment as early as possible. Research has determined the optimality score for this test for term infants evaluated in the first days after birth. Subsequently, the current version of the HNNE was standardized by evaluating low-risk term and high-risk preterm infants (25-34 weeks) at term ages, 6-48 hours after birth.The aim of this study was to develop a Turkish version of the HNNE for infants at risk in Turkey and determine its validity and reliability. The translated HNNE version, which was found to be valid and reliable in this population, will be suitable for use by all healthcare professionals in Turkey. This study also aimed to determine the predictive value of HNNE at corrected 3-4/6 and 12 months when used in the follow-up of at-risk infants in NICUs in Turkey.The study consists of two phases. The first phase consisted of translating the short version of the survey into Turkish and conducting its cultural adaptation. The second phase involved reliability analysis. The principles of Guillemin et al. and Beaton et al. will be used in the translation and cultural adaptation processes.

Effect of Whirlpool Therapy Combined With Botulinum Toxin in Children With Cerebral Palsy

This study aims to investigate the effects of adding whirlpool therapy to standard rehabilitation in children with cerebral palsy who recently received botulinum toxin-A injections. Participants will be divided into two groups: one group will receive standard physiotherapy, while the other group will receive physiotherapy combined with whirlpool therapy. The effects of these interventions on spasticity, gait function, and motivation will be evaluated over a 12-week follow-up period.

Experiences of Managing Sleep Disordered Breathing in Children 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. 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 analyse the experiences of children with CP being managed for SDB, and the views of their carers/parents, and health professionals involved in their care. By undertaking semi-structured interviews, the investigators aim to explore the impact SDB and it's management has on children

Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy

The goal of this clinical trial is to learn if a two month training with the Agilik powered orthosis improves the knee extension or the endurance in pediatric patients with Cerebral palsy and a crouch gait. It will also learn about the safety of Agilik. The main questions it aims to answer are: Does the Agilik powered orthosis increase the value of the knee extension during walking? What medical problems do participants have when using the Agilik powered orthosis? Researchers will compare a group of patients using the Agilik powered exoskeleton with a group of patients treated with standard therapy. Participants will: Use Agilik at home or perform standard therapy for 2 months Visit the clinic at the beginning of the study, after 3 months and after 1 additional month.

Effect of Aquatic Therapy Program on Balance in Children With Spastic Diplegic Cerebral Palsy

1. Evaluate the effect of a structured aquatic therapy programme on static balance in children with spastic diplegic cerebral palsy. 2. Assess the effect of the same programme on dynamic balance in this patient population. 3. Compare balance outcomes between children receiving aquatic therapy and those receiving conventional land-based physiotherapy.

Individualized Nutrition Intervention in Children With Cerebral Palsy

The goal of this clinical trial is to learn if individualized nutrition support can improve nutrition, gastrointestinal symptoms, and quality of life in children with cerebral palsy. The main questions it aims to answer are: Does individualized nutrition support improve the nutrition status of children with cerebral palsy? Does individualized nutrition support improve gastrointestinal symptoms and quality of life? Researchers will compare children who receive individualized nutrition support with children who receive routine care. Participants will: Be randomly placed into one of two groups Have their nutrition status assessed Have their gastrointestinal symptoms and quality of life assessed Receive individualized nutrition support or continue routine care

Robotic Knee Orthosis-assisted Walking in CP

Robotic exoskeletons are becoming increasingly accepted to provide upright mobility in individuals with neurological disorders. These devices can assist in overcoming gravitational forces and reduce energy consumption. Agilik is one such device intended for individuals with neurological disorders. However, Agilik is relatively new, and its efficacy in individuals with CP is unknown. Therefore, this study aims to assess the effectiveness of Agilik as an assistive device for individuals with CP and crouch gait. In this pilot study, ten individuals with CP, GMFCS levels I and II, and crouch gait will walk with Agilik under the supervision of a physical therapist. Assessments of walking with shoes or AFO and Agilik will evaluate the efficacy of the device. The pilot study will assess if Agilik decreases crouch and improves gait characteristics in individuals with CP.

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.

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.

Speech and Arm Combined Exergame

The purpose of this study is to develop innovative home therapy games to train the weak arm and improve speech intelligibility (clarity) of children with hemiplegia from cerebral palsy. The investigators are exploring the effects of these therapy games and how they change the children's speech, hand movement, and brain activation. 15 children who are 8-17 years old will be recruited for this study. These children should have a diagnosis of cerebral palsy, mild to moderate speech issues but use speech as the primary mode of communication, mild to moderate movement difficulty and muscle spasticity, adequate hearing (pass a hearing screening), and be able to follow simple task-related directions. Children who have severe vision impairment that limits the child's ability to interact with the entire computer screen, have severe arm weakness so they cannot move their arm enough to interact with the computer games, have severe increase in tone in their weak arm, or have difficulty following instructions or paying attention to computer video games for at least 10 minutes cannot participate in this study. The therapy games will take 8 weeks to finish at home. Each child will play these games for 30 minutes each day, 5 days per week. In addition, children will come to the lab 4 times for speech and hand movement assessment: (1) 1st assessment takes place immediately before the child start to play the video games. (2) 2nd assessment takes place 4 weeks (midpoint) after the child starts to play the games. (3) 3rd assessment takes place immediately after the video games are finished. (4) 4th assessment takes place 6 weeks after the video games are finished. Each assessment should take about 2 hours to complete in the Rutgers movement lab or at Rutgers SLP Clinic. A total of 15 children will take part in this research study. The research will last for 2 years overall.

Impact of Task-Specific Electrical Stimulation on Upper Limb Functional Motor Skills in Children With Spastic Quadriplegia

Cerebral palsy is a non-progressive lesion of the brain occurring before 2 years of age resulting in disorders of posture and movement.( Ostensjo S, 2004)( Keles MN, 2018) . Although non-progressive, motor impairments develop as the child grows leading to activity and participation restriction. For children with CP, body function and structure impairments include changes in muscle tone and strength that affect the ability to control movement, specifically in regard to postural responses, selective control, regulation of activity, ability to learn unique movements, and inappropriate sequencing.(Ross SA, 2007)( Ostensjo S, 2004) . Lack of proper loading and maladaptive muscle pulls over time causes the skeletal system to adapt to positions of malalignment, malformation, and overall bone weakness (Beckung E, 2007) (Elbasan B, 2018) . These changes lead to delays in the natural progression of gross motor skills. As the child falls behind in motor function, they also fall behind in cognitive stimulation and development.( Akaya KU, 2018) . Understanding the anatomical and physiological implications that CP has on the developing child is necessary for physical therapists to treat this population, especially when utilizing electrical stimulation. Spastic quadriplegia Is a type of cerebral palsy that affects all four limbs and typically involves significant motor impairment. It results from brain damage that occurs before, during, or shortly after birth, affecting the areas of the brain responsible for movement and coordination. Electrical stimulation is a mode of physical therapy that can be utilized in the treatment of various nerve and muscle injuries, in addition to patients with acute and chronic pain. It involves an electrical pulse applied to a muscle or nerve that activates excitable tissue utilizing internal or external electrodes to build muscle strength, reduce pain, as well as create or support limb movement (Kerr C, 2007) .

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

Speech Production Enhancement Using Augmentative Communication for Kids

The goal of this clinical trial is to learn if speech supplementation can improve speech intelligibility in children ages 7 to 17 years with cerebral palsy. The main questions it aims to answer are: * To what extent can speech supplementation improve intelligibility in children with CP compared with habitual speech produced without speech supplementation? * How much intelligibility change is necessary for meaningful improvement when children use speech supplementation strategies? Participants will: * complete speech and language assessments * complete a speech pre-test using habitual speech * learn a speech supplementation strategy with training from a speech-language pathologist * complete a speech post-test using the speech supplementation strategy * complete a speech repetition task where specific words are emphasized (emphatic stress) * use the previously learned speech supplementation strategy + emphasis on specific words while producing a set of sentences

The Effect of Spinal Manipulation on Heart Rate Variability in Children With Cerebral Palsy.

This randomized, sham-controlled crossover trial aims to evaluate the immediate effects of spinal manipulation on heart rate variability in children with cerebral palsy. Each participant will attend four experimental sessions conducted on separate days. In two sessions, spinal manipulation will be performed, and in two sessions, a sham procedure will be applied. The order of interventions will be randomized for each participant. Heart rate variability will be recorded before and after each intervention.

Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy

The goal of this clinical trial is to evaluate the feasibility and user satisfaction of a non-immersive VR rehabilitation system, i.e. Rehametrics, for gait and balance training in children with CP in children between 4 to 10 years old. Secondary objectives include assessing the system's impact on functional mobility, gross motor function, balance, active participation, and user experience. Primary hypothesis: rehabilitation intervention with Rehametrics is feasible and well accepted in a clinical setting for children with CP aged 4 to 10 years. Participants will train exercises related to balance and gait using Rehametrics platform

Comparison of Sensory Integration Therapy and Conventional Physical Therapy on Gross Motor Function in Children With Athetoid Cerebral Palsy: A Randomized Controlled Trial

This is an RCT aiming to explore the comparison of Sensory Integration Therapy and Conventional Physical Therapy on Gross Motor Function in Children with Athetoid Cerebral Palsy

Effects of Motor Imagery and Action Observation on Motor Function in Unilateral Cerebral Palsy

The aim of this study is to evaluate the effects of action observation therapy and motor imagery methods, provided in addition to a conventional physiotherapy and rehabilitation program, on gross motor function, upper and lower extremity functional skills, and quality of life 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.

Assessing Intellectual and Motor Outcomes in High-risk Infants

Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated issues with their motor skills. Some newborns are at higher risk of developing CP, including babies born prematurely, those who have an injury to their brain, and those who have an abnormal neurological examination. However, most babies with a higher risk of CP do not develop CP. The problem is that doctors can't tell early on who will and who will not develop CP, they can only say who has a risk of it. Therefore, these babies are followed up in out-patient clinics to see how they are progressing, usually by a neonatologist (baby doctor), often a physiotherapist, and some may also be referred to services in the community like the Early Intervention Team. If there is a significant concern, doctors will often perform a scan of the baby's brain to provide more information. Even with all this follow-up, it still usually takes at least 12 months, and can be up to 2 years, to diagnose a child as having CP. In this study the aim is to try and reduce the age of diagnosis of CP by assessing children in high-risk out-patient clinics using novel and specific examinations. We would also like to improve our ability to predict who will need help with learning, language or other non-motor outcomes. This study is being conducted at several hospitals in Ireland, including Cork University Maternity Hospital (CUMH), The Rotunda Hospital and the Coombe Women and Infants Hospital. It is being coordinated by the In4kids network and will be conducted in the INFANT Centre/ University College Cork (UCC). The study has been funded by Research Ireland and the Cerebral Palsy Foundation, USA.

Combined Effect of FES And FCT in Cerebral Palsy

To determine the combined effect of functional electrical stimulation and functional circuit training on postural stability, balance, and functional mobility in cerebral palsy

Complex Rehabilitation Technology Enabled Physical Activity for Children With Motor Delays Via Telehealth in Natural Environments

The primary goal of CP-MOVES is to evaluate 1) the preliminary efficacy of a telehealth-delivered, parent coaching intervention in the use of adaptive standers, on physical activity, sleep, and endurance in young children with severe motor delays and 2) on physical activity, sedentary time, resting heart rate, and perceived stress in parents. The main questions the study aims to answer include: 1. Do measures of physiological fitness and sleep in children with severe motor delays (i.e., unable to stand without support) change after a therapist-directed, parent-delivered intervention using telehealth and adaptive standers? 2. Do parents report any changes in their child's endurance, participation, or quality of life OR parent stress following intervention? Children ages 1-6 years old with severe motor delay and one parent will: 1. Complete three 30 minute sessions of standing in an adapted stander per week for 8 weeks. One session per week will be completed with a physical therapist, delivered through telehealth and two sessions per week will be completed as a home program with the parent and child (no therapist or telehealth). 2. Wear activity tracker sensors on the wrist(s) and waist for one-week before and after treatment. 3. Complete questionnaires about the child's endurance, participation, and quality of life and the parent's stress, before and after treatment. 4. Complete an assessment of postural control before and after treatment. 5. Complete an post-treatment interview

tDCS and Bi-manual Training in Cerebral Palsy

Unilateral spastic cerebral palsy (USCP) is the most common subtype of cerebral palsy and significantly limits upper limb function. Traditional therapies such as constraint-induced movement therapy (CIMT) and bimanual intensive training offer limited benefits. Pharmacologic treatments often produce behavioral side effects and do not address underlying neuro-plastic deficits. There is an unmet need for safe, effective, non-invasive interventions targeting motor recovery through cortical modulation.