Clinical Research Directory

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.

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.

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.

Activities-based Locomotor Training in Children With Cerebral Palsy

This project aims to improve the quality of life and functional outcomes for young non-ambulatory children with Cerebral Palsy (CP) by investigating the efficacy of an Activities-Based Locomotor Training (AB-LT) program compared to usual care. By targeting the body structures, activities, and participation components of the World Health Organization's International Classification of Functioning, Disability, and Health (ICF) framework, this study seeks to enhance our understanding of neuroplasticity and motor learning in this population, offering a novel approach to rehabilitation. Results from this research will lead to more effective, individualized therapies that improve motor function, reduce disability, and ultimately lower the long-term healthcare needs associated with CP.

Effect of a Humanoid Robot With Virtual Reality Games to Train Arm Function in Children With Cerebral Palsy - THRIVE Trial

About 60% of children with cerebral palsy (CP) have impaired arm function. Improving arm function requires hundreds of repetitions per day, which is impossible in a single clinical visit. Thus, therapeutic exercises should be sustained in the home environment; however, the compliance in performing home exercise is low due to poor motivation, boredom, and forgetfulness. A better home program is needed. The objective of this project is to examine the effect of our developed "THRIVE" system (Therapeutic Humanoid Robot In Virtual Environment: the combination of robot with virtual reality games), which can provide a motivating and tailored upper-extremity intervention program with instant feedback, to improve arm function in children with CP at their home. The investigators believe the newly developed "THRIVE" system can increase children's engagement and motivation in home exercises as the robot is their playmate to demonstrate and correct their movements. The investigators will also interview parents and children with CP to understand their impression of using technology at home to shape the intervention. The expected outcome is that children with CP receiving "THRIVE" will improve their arm function more and have better engagement than those who receive VR alone immediately after intervention and at follow-up. The long-term goal is to have the "THRIVE" system be the optimal home exercise platform as it can provide challenging but motivating exercises to improve children's arm function while assisting parents in supervising their children with CP to complete home exercises.

Metacognitive Strategy Training Intervention for Transition-Age Youth With Cerebral Palsy

This exploratory randomized controlled trial will examine the feasibility and preliminary effects of a remote PREP intervention compared to an attention control for transition-age youth with cerebral palsy and their caregivers. Youth-caregiver dyads will complete remote baseline assessments and be randomized to a 12-week intervention or attention control, with weekly virtual sessions. Feasibility outcomes will be primary, with secondary outcomes exploring preliminary efficacy. Post-intervention assessments and optional interviews will be conducted remotely to capture outcomes and participant experiences.

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).

Structured Graphic Motor Therapy in Pediatric CP

Structured Graphic Motor Therapy (SGMT) is a novel task-oriented rehabilitation approach that uses standardized, progressively challenging drawing trajectories to improve upper-limb motor function in children with cerebral palsy. This pilot randomized controlled trial will compare SGMT combined with conventional rehabilitation with conventional upper-limb rehabilitation alone over a 16-week intervention period. Standardized clinical assessments and quantitative image-derived measures of graphical motor performance will be used to evaluate changes in motor function, visuomotor coordination, and movement quality.

Effect of rESWT Session Frequency on Spasticity and Function Assessed by Sonoelastography in Children With Cerebral Palsy

Spasticity is a major contributor to functional limitations in children with cerebral palsy. Radial extracorporeal shock wave therapy (rESWT) has emerged as a non-invasive method for reducing spasticity; however, the optimal session frequency remains unclear. This randomized, assessor-blinded, parallel-group controlled trial investigates the effects of different rESWT session frequencies on spasticity, motor function, balance, pain, and muscle properties in children with cerebral palsy. Participants are randomly assigned to three groups receiving sham rESWT, one real rESWT session per week combined with sham, or two real rESWT sessions per week, in addition to routine neurological rehabilitation. Outcomes are assessed using clinical scales and ultrasonography-based measures, including shear wave elastography. The study aims to define the dose-response relationship of rESWT and inform optimal treatment protocols in pediatric neurorehabilitation.

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

Effect of Intensive Segmental Trunk Training on Upper Extremity Function and Seated Postural Stability in Children With Spastic Diplegic Cerebral Palsy

The goal of this randomized controlled trial is to evaluate whether intensive segmental trunk training (ISTT) can improve upper extremity function and seated postural stability in children aged 4-12 years with spastic diplegic cerebral palsy and moderate trunk control impairments. The main questions it aims to answer are: Does intensive segmental trunk training lead to greater improvements in seated postural stability compared to standard physical therapy? Does intensive segmental trunk training lead to greater improvements in upper extremity function compared to standard physical therapy? Researchers compared the ISTT group to the control group (standard physical therapy) to see if the targeted trunk training produces significantly better outcomes in trunk control, upper extremity skills, and gross motor function. Participants underwent their assigned training regimen five times per week for eight weeks and complete pre- and post-intervention assessments measuring trunk control (SATCo, TCT), upper extremity function (QUEST, Box and Block Test), and gross motor function (GMFM-88).

Parental Experiences of Home-Based Intensive Segmental Trunk Training in Children With Cerebral Palsy

The goal of this feasibility study is to evaluate the adherence, parental experiences, and perceptions of a home-based Intensive Segmental Trunk Training (ISTT) program for children aged 4-12 with spastic diplegic cerebral palsy (CP) in Pakistan. The main questions it aims to answer are: What is the rate of caregiver adherence to a home-based ISTT program over 12 weeks? What are the primary barriers, experiences, and perceptions of caregivers implementing the program? What are the preliminary signals of clinical effectiveness on trunk control and gross motor function? Researchers will compare pre- and post-intervention outcomes (baseline vs. week 12) to see if there are statistically significant improvements in trunk control (measured by SATCo) and gross motor function (measured by GMFM-88). Participants (20 primary caregivers and their children) will: Attend an initial in-person orientation session to learn trunk stabilization exercises from a senior pediatric physical therapist Complete a 12-week home-based ISTT program with weekly tele-supervision video calls to monitor progress and address challenges Attend monthly face-to-face monitoring visits at the hospital for clinical assessment and technique reinforcement Complete a KABA (Knowledge, Attitudes, Barriers, and Adherence) survey at baseline and week 12 Participate in a semi-structured interview at the end of the 12-week program to share their experiences.

Comparison of Synchronous and Asynchronous Action Observation Therapy in Children With Cerebral Palsy

The aim of this study is to compare the effects of synchronous and asynchronous action observation therapy (AOT) on balance, gait, and functional capacity in children with cerebral palsy (CP). CP is a neurodevelopmental disorder characterized by impairments in motor skills, particularly motor control and postural balance. By examining the contributions of synchronous (real-time) and asynchronous (delayed) AOT methods to motor performance, this study seeks to identify the most effective therapeutic approach for this population.

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.

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.

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.