Clinical Research Directory

Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy

The goal of this interventional study is to learn about the biomechanical factors underlying the beneficial changes in children with cerebral palsy after using individually-adapted stand-on ride-on power mobility devices (PMD). The main questions we aim to answer are: * How does the use of stand-on PMDs affect static balance in children with cerebral palsy? * How does the use of stand-on PMDs affect dynamic balance and mobility function in children with cerebral palsy? Children ages 4-6 years old with cerebral palsy (GMFCS levels II and III) will: * Use individually-adapted stand-on PMDs for three months. * Undergo tests to measure static balance, dynamic balance, and mobility function before and after the intervention. * Receive a full biomechanical assessment (kinematics, kinetics, muscle activity, gait spatiotemporal characteristics). Researchers will compare pre-intervention and post-intervention measurements to quantify improvements in balance, muscle activation, and mobility.

Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders

Background: \- Cerebral palsy (CP) is the most common motor disorder in children. CP often causes crouch gait, an abnormal way of walking. Knee crouch has many causes, so no single device or approach works best for everybody. This study s adjustable brace provides many types of walking assistance. Researchers will evaluate brace options to find the best solution for each participant, and whether one solution works best for the group. Objective: \- To evaluate a new brace to improve crouch gait in children with CP. Eligibility: * Children 5 17 years old with CP. * Healthy volunteers 5 17 years old. Design: * All participants will be screened with medical history and physical exam. * Healthy volunteers will have 1 visit. They will do motion analysis, EMG, and EEG described below. * Participants with CP will have 6 visits. * Visit 1: \<TAB\>1. Motion analysis: Balls will be taped to participants skin. This helps cameras follow their movement. \<TAB\>2. EMG: Metal discs will be taped to participants skin. They measure electrical muscle activity. \<TAB\>3. Participants knee movement will be tested. \<TAB\>4. Participants will walk 50 meters. \<TAB\>5. Participants legs will be cast to make custom braces. * Visit 2: * Participants will wear their new braces and have them adjusted. * Steps 1 3 will be repeated. * EEG: Small metal discs will be placed on the participants scalp. They record brain waves. * Participants will have electrical stimulation of their knees and practice extending them. * Participants will take several walks with the braces in different settings. * Visits 3 5: participants will repeat the walking and some other steps from visit 2. * Visit 6 will repeat visit 2.

Speech Therapy Settings in Cerebral Palsy

Cerebral palsy (CP) is a common neurodevelopmental disorder affecting motor functions, cognition, and communication skills in children. Speech and language delays are prevalent among children with CP, significantly impacting their social interactions and daily life activities. This study aims to compare the effectiveness of hospital-based professional speech and language therapy with home-based parent-guided interventions for language development in children aged 18-36 months with CP. Participants will be assessed at baseline and after 6 months using standardized tools measuring motor functions, manual abilities, communication skills, and functional independence. The study will provide valuable insights into optimizing therapeutic approaches for language and communication development in children with CP.

Virtual Reality vs Functional Strength Training in Children With Cerebral Palsy

Virtual reality (VR) has shown to be effective to improve arm function in children with cerebral palsy (CP). Recently, functional strength training (FST) starts to show to improve arm function in patients with stroke but has not been extensively explored in children with CP. This pilot study is to examine the effect of FST and VR on improving arm function in children with CP using a sequential multiple assignment randomized trial (SMART) to develop valid, high-quality adaptive intervention using VR and FST to improve arm function in children with CP. There is a growing interest and need for research on how to adapt and re-adapt intervention in children with CP in order to maximize clinical benefits. The treatment adapted here is by augmenting or switching to the other intervention. Forty children with spastic type of CP will be recruited from the greater Atlanta area. Children will be randomly assigned to receive either VR or FST for 6 weeks (60 minutes per day, 3 days per week). After receiving 6 weeks of intervention, the children will be evaluated to determine whether they are responders or non-responders. For those who are responders, they will continue receiving the same dosage and type of intervention. That is, children who are assigned to VR will continue receiving VR for the next 6 weeks; children who are assigned to FST will continue receiving FST for the next 6 weeks. For those who are non-responders, children will be randomly assigned to augmenting the other intervention or switching to the other intervention. That is, for children who are assigned to augmenting the other intervention (i.e. the combination group), they will receive the combination of FST and VR for the next 6 weeks. For children who are assigned to switch to the other intervention, children who are assigned to VR in the first 6 weeks will receive FST for the next 6 weeks; whereas children who are assigned to FST in the first 6 weeks will receive VR for the next 6 weeks. Similar instruction, visit, and email reminder will be conducted as what they receive in the first 6 weeks. At the end of the study, children and primary caregivers will be interviewed to understand their perception about the intervention they have received. The research team is expected children with CP will improve their arm function regardless which intervention they are assigned; however, children received VR will have a better improvement in arm function as compared with those who received FST at the end of the intervention.

Cerebral Palsy and the Study of Brain Activity During Motor Tasks

Background: \- Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS) and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it is active. EEG records electrical activity in the brain. Both have been used safely for many years, even in very young children. NIRS or EEG can be used while a person is moving to show which parts of the brain are the most active. Researchers want to use NIRS and EEG to study brain activity during movement in people with cerebral palsy and healthy volunteers. Learning more about how people with and without cerebral palsy use their brain to control their muscles may lead to new ways of training people with cerebral palsy to move better. Objectives: \- To study how the brain controls body movement in people with and without cerebral palsy. Eligibility: * Individuals at least 5 years of age who have cerebral palsy. * Healthy volunteers at least 5 years of age. Design: * This study has three parts. People with cerebral palsy will be selected for all three. Healthy volunteers will be asked to do only two of them. Everyone who participates will have NIRS and/or EEG exams during movement. People with cerebral palsy may also have biofeedback sessions to train coordination of movement and brain activity. * Participants will be screened with a physical exam and medical history. Urine samples may be collected. * All participants will have at least one session of NIRS and/or EEG imaging studies. Sessions may also include the following tests: * Magnetic resonance imaging to look at the brain * Electromyography to measure electrical activity of the muscles * Motion analysis of specific body parts * Ultrasound to measure activity of the muscles * Motorized, robotic, and electrical stimulation of the muscles * Other clinical tests of muscle movement as needed. * Participants with cerebral palsy will have biofeedback sessions. These sessions will help them learn to coordinate muscle movement and brain activity.

Effects of Core Stability Program on Abdominal Endurance in Wheelchair Bound Cerebral Palsy

This study aims to evaluate the effects of a Core Stability Program on abdominal endurance and constipation severity in wheelchair-bound children with cerebral palsy. It seeks to determine whether targeted core strengthening exercises can improve muscular endurance of the abdominal region while also alleviating constipation symptoms, thereby enhancing overall functional health and quality of life in this population.

A Novel Program Using Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia

The purpose of this study is to assess the feasibility and utility of 2 types of play-based training programs co-delivered by researchers and caregivers within home/community settings to promote arm function among 3-to-8-year-old children with hemiplegia. Specifically, investigators will assess the feasibility of implementation and acceptance/satisfaction associated with a researcher-caregiver co-delivered community-based training program involving either joystick-operated powered ride-on toys (SPEED training) or creative upper extremity training (CRAFT training). The investigators will also compare the effects of these 2 types of training programs on children's arm motor function and spontaneous use of their affected arm during daily activities.

Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation

The goal of this study is to test the effects of transcranial direct current stimulation (tDCS) on motor learning and brain plasticity in children with unilateral spastic cerebral palsy (USCP).

Effect of Sunlight Exposure on Vitamin D Levels in Children With Cerebral Palsy

The goal of this clinical trial is to learn the effect of sunlight exposure on serum vitamin D levels in children aged 1-5 years with cerebral palsy. This study also aims to assess the effect of sunlight exposure on the incidence of acute respiratory tract infections and to evaluate the safety of the intervention. The main questions it aims to answer are: * Does sunlight exposure increase vitamin D levels in children with cerebral palsy? * Does sunlight exposure influence the incidence of acute respiratory tract infections in children with cerebral palsy? * Does sunlight exposure cause acute adverse effects in children with cerebral palsy? Participants will: * Be randomly assigned to either the sunlight exposure group or the control group. * Undergo baseline assessments, including vitamin D levels measurement, anthropometric measurements, dietary assessment, and Fitzpatrick skin phototype assessment before randomization. * Receive sunlight exposure for 10 minutes, three times per week between 11:00 AM and 1:00 PM for 8 weeks (intervention group), while participants in the control group will continue their usual sunlight exposure habits. * Have caregivers record daily sunlight exposure (intervention group), acute respiratory tract infection episodes, adverse events, and dietary intake during the study period. * Undergo repeat vitamin D levels measurement and evaluation of dietary intake, acute respiratory tract infections incidence, and adverse events at the end of the 8-week intervention.

A Feasibility Randomised Controlled Trial of an Online Exercise Programme for Adults With Cerebral Palsy

Adults with cerebral palsy (CP) often face challenges in accessing exercise programmes that are appropriate for their needs. Barriers such as limited mobility, a lack of tailored options, and restricted access to physiotherapy services can make participation difficult. Exercise is important for improving physical health, mental well-being, and overall quality of life. However, many adults with CP do not have regular opportunities to take part in structured physical activity. This study aims to investigate whether an online exercise programme can serve as an effective and accessible alternative. The main aim of the study is to assess the feasibility of delivering an online exercise programme for adults with CP. Key areas of focus will include demand, implementation, practicality, adaptability, acceptability, and potential benefits to physical, mental, and social well-being. A total of 60 adults with CP will be recruited and randomly assigned to one of two groups (30 participants per group). One group will complete an 8-week online exercise and education programme. The second group will receive the same educational materials during the study and will be provided with information about the home exercise programme after the 8-week intervention period. Data will be collected on attendance, completion rates, engagement with exercises, and any reported adverse events. Health-related surveys will be completed before and after the programme to assess any changes. In addition, a selected group of participants from the intervention group will take part in interviews to provide feedback on their experiences. Findings from this study may support the development of accessible, effective, and person-centred online exercise programmes for adults with CP. Results may help improve future programme design and contribute to better care and support for adults with CP in Ireland.

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).

NEO-REEDUC - Mixed Reality for Motor Rehabilitation: a Prospective, Multicenter, Controlled, Randomized, Open Study.

This study aims to assess the effectiveness of a motor rehabilitation protocol that includes mixed reality activities, compared to conventional rehabilitation, on postural stability in children and adult patients with neurological impairments.

Motus Nova Foot Device for Patients With Hemiplegia

Individuals with hemiplegia commonly demonstrate gait deviations such as difficulties with heel strike at initial contact, foot drop in swing, asymmetrical limb loading, muscle activation, and balance impairments. This study evaluates whether a therapeutic device (Motus Nova Foot; FDA approved) used in the home setting can increase heel strike, decrease limp, improve foot clearance in swing phase, improve quality of active muscle contraction of the affected limb, and improve balance. The Motus Nova Foot moves the ankle/foot and uses guided computer/video activities to encourage active participation while automatically recording device use and duration.

Effect of Transcranial Direct Current Stimulation on Hand Recovery and Quality of Life in Hemiparetic Cerebral Palsied Children

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may help improve hand function in children with cerebral palsy. This study investigates whether tDCS combined with functional task training is more effective than functional task training alone for improving hand recovery and quality of life in children with hemiparetic cerebral palsy. Sixty children aged 7 to 12 years with hemiparetic cerebral palsy will be randomly assigned to one of two groups. The experimental group will receive anodal tDCS at 2mA for 20 minutes, 3 times per week for 1 month, combined with 40 minutes of functional task training. The control group will receive functional task training alone for 60 minutes, 3 times per week for 1 month. Hand function will be measured using the Jebsen Taylor Hand Function Test and grip strength using a hand held dynamometer. Spasticity will be assessed using the Modified Ashworth Scale, and quality of life will be measured using the Pediatric Quality of Life Inventory 4.0 (PedsQL). All assessments will be conducted before and after the 1-month treatment period. The findings of this study may help determine whether adding tDCS to standard rehabilitation provides additional benefits for hand recovery and quality of life in children with hemiparetic cerebral palsy.

Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries

This protocol is designed to enable access to intravenous infusions of banked umbilical cord blood (CB), that is thawed and not more than minimally manipulated, for children with various brain disorders. Children with cerebral palsy, congenital hydrocephalus, apraxia, stroke, hypoxic brain injury and related conditions will be eligible if they have normal immune function and do not qualify for, have previously participated in, or are unable to participate in an active cell therapy clinical trial at Duke Medicine. For the purpose of this protocol the term children refers to patients less than 26 years of age. Cord blood is administered as a cellular infusion without prior treatment with chemotherapy or immunosuppression. The mechanism of action is through paracrine signaling of cord blood monocytes inducing endogenous cells to repair existing damage.

Strength Training Combined With Blood Flow Restriction and Cerebral Palsy

load resistance exercises are performed while partially restricting venous blood flow to the exercising limb using a pneumatic cuff. In children with hemiplegic cerebral palsy, this intervention has been proposed to enhance muscle strength and hypertrophy while minimizing mechanical stress on joints and soft tissues. Previous studies suggest that BFR training may improve muscle thickness, muscle strength, functional mobility, gait performance, and overall physical function compared with conventional low-intensity strength training alone. However, careful monitoring of cuff pressure, exercise intensity, and safety considerations is essential when applying this technique in pediatric populations.

Exopulse Mollii Suit, Motor Functions & CP Children With Cerebral Palsy

Cerebral Palsy (CP) is is estimated to be around 1.5-3 per live birth, with prenatal factors accounting for 75% of cases. CP appears in early childhood and persists with age and is characterized by permanent lesions or abnormalities affecting the immature brain. It mainly occurs as a motor system disorder (e.g., abnormal movements or posture) with the presence of hemiplegia, diplegia or tetraplegia, and spastic, dyskinetic or atactic syndromes. .This study will explore the potential clinical benefits of the Molliimethod in children with cerebral palsy. Spasticity impacts balance and mobility, halts the patients quality of life and their ability to perform their activity of daily living, and could also increase the risk of fractures and falls. Available interventions that aim on improving spasticity are facing limitations such as varios side effects. Therefore, developing novel therapies such as the EXOPULSE Mollii Suit could help to overcome such limitations and noninvasively improve balance, mobility, quality of life and reduce spasticity and pain in children with CP.

Effects of Lokomat-Robot Assisted Gait Training on Gross Motor Function in Children and Young Adults With Cerebral Palsy

This single-center, controlled, delayed-intervention, quasi-experimental study evaluates the effectiveness of Lokomat®-assisted robotic gait training on gross motor function and health-related quality of life in children and young adults with cerebral palsy. Although previous studies have reported improvements in walking ability, gross motor function, and lower limb performance following Lokomat-assisted gait training, uncertainty remains regarding the optimal treatment intensity and dosing schedule, particularly across different age groups and levels of functional impairment. The primary objective of this study is to evaluate the effect of a 20-session (8 week) Lokomat-assisted gait training program on standing and walking function, assessed using Dimensions D and E of the Gross Motor Function Measure (GMFM-88). Secondary objectives include evaluation of lower limb muscle strength, walking speed, health-related quality of life, individualized rehabilitation goal attainment, and objective gait training parameters recorded by the Lokomat® system. The study employs a controlled, delayed-intervention, quasi-experimental design conducted over three consecutive study periods. During each study period, one intervention group receives Lokomat-assisted gait training in addition to usual rehabilitation, whereas a concurrent control group receives usual rehabilitation alone. As standard (usual) rehabilitation participants receive nationally approved standard-of-care rehabilitation, which may include neurorehabilitation, physiotherapy, and/or educational (pedagogical) rehabilitation, as appropriate to their individual clinical needs and routine care. After completion of the control period and post-intervention assessment, participants in the control group receive the same 20-session Lokomat-assisted gait training program and physiotherapy program during the subsequent study period. Participants allocated to the control group during the final study period receive the intervention after completion of the formal study period.

Neuromodulation of the Cortex and Spinal Cord

Specific Aim 1: To further quantify the difference in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence of persons with CP. Overall hypotheses: The sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be uncharacteristic in persons with CP when compared with neurotypical controls. Furthermore, the extent of the alterations in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be tightly linked with the clinical presentations of persons with CP. Specific Aim 2: To investigate the effect of transcutaneous current stimulation applied over the cortex and/or spinal cord on the sensorimotor cortical activity, spinal cord dynamics, and corticospinal coherence. Overall hypotheses: Compared with the sham controls, those receiving the transcutaneous current stimulation will demonstrate alterations in the strength of the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence. Moreover, the extent of the alterations in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be tightly linked with the clinical presentations of persons with CP.

Improving Activity in Individuals With Cerebral Palsy

Individuals with cerebral palsy are known to have a reduced amount of physical activity; yet, there are no known intervention strategies for improving the number of steps they take each day. This study will use wearable physical activity monitors to assess if behavioral coaching is a viable strategy for combating the reduced physical activity seen in this patient population.

How Much Virtual Reality Intervention Improve the Balance of Patients With Cerebral Palsy

The purpose of this clinical study is to investigate how effective virtual reality applications are in adult cerebral palsy rehabilitation. The main questions it aims to answer are: Do virtual reality interventions (of Becure Balance and Becure Wesense Systems) improve balance and is this improvement reflected in the clinic? Is there a change in brain functional resting state networks after virtual reality interventions?

Igniting Mobility in Adolescents and Young Adults With Cerebral Palsy

The study design will consist of a cohort of adolescents and young adults with cerebral palsy (CP) that will undergo a gait training protocol. All participants will complete MEG or EEG baseline brain imaging measures of their sensorimotor cortical activity, MRI brain/spinal cord imaging (previous MRI or template brain may be substituted), neurophysiological tests of the spinal cord H-reflex, and a series of mobility clinical tests and cognitive tests. Participants with metal in their body that would interfere with the MEG (e.g., braces on teeth, permanent retainer) will not undergo the MEG tests but will undergo the EEG assessments. Those who complete the MEG assessments will not undergo the EEG assessments. After completing the baseline tests, the participants with CP will undergo the therapeutic gait training. After completing all of the therapeutic gait training sessions, the participants with CP will repeat the same assessments that were completed at baseline. Separately, a cohort of neurotypical adolescents and young adults will also complete the baseline assessments. The neurotypical participants will not undergo the therapeutic gait training, but will be used as a normative group for interpreting if the changes seen in the participants with CP after therapy are in fact moving the system toward a normative state.

Smartphone Accelerometry for Gait Analysis in Children With Unilateral Spastic Cerebral Palsy

This observational study will evaluate whether a smartphone's built-in accelerometer can provide accurate and repeatable measurements of walking in children with unilateral spastic cerebral palsy. Thirty-five children aged 6 to 12 years will complete two walking trials along a 10-meter indoor walkway at their usual comfortable speed. During each trial, a smartphone will be secured over the lower back at the L4-L5 level to record body acceleration using the Phyphox application. At the same time, a video camera will record the child's walking for analysis using Kinovea software. Measurements obtained from the smartphone will be compared with measurements obtained from video analysis. The study will assess walking velocity, cadence, stride timing, and gait asymmetry. The two repeated walking trials will also be used to determine whether the smartphone measurements are consistent when the test is repeated during the same session. The study does not involve any treatment or change to the child's usual medical or physical therapy care. The purpose is to determine whether smartphone-based gait assessment may be a practical, low-cost method for evaluating walking in children with unilateral spastic cerebral palsy.

Effect of Coordinative Locomotor Training in Children With Cerebral Palsy

Cerebral palsy is a brain disorder that affects how children move their bodies. Children with spastic hemiplegic CP have stiffness on one side of the body, making it hard to walk and balance. This study will test a special exercise program called Coordinative Locomotor Training (CLT). CLT uses running and skating movements to train both arms and legs to work together. The investigator want to see if CLT works better than regular physiotherapy for improving coordination and balance in participants. Half of the children will do CLT, and the other half will do regular exercises. The investogar will measure their balance and walking ability before and after 4 weeks of training.