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NCT07587476
This randomized controlled trial aims to compare the effectiveness of Constraint-Induced Movement Therapy (CIMT) combined with Functional Electrical Stimulation (FES) versus CIMT alone in improving upper limb function, reducing spasticity, and enhancing functional independence in children with cerebral palsy (CP). A total of 46 children aged 3 to 15 years with spastic or dyskinetic cerebral palsy will be recruited from rehabilitation centers and hospitals in Sukkur, Pakistan. Participants will be randomly assigned into two groups: Group A will receive CIMT combined with FES, while Group B will receive CIMT alone. Both groups will undergo supervised therapy sessions five times per week for six weeks. Outcomes will be assessed before and after treatment using the Modified Ashworth Scale (MAS), Melbourne Assessment of Unilateral Upper Limb Function (MUUL), and Pediatric Evaluation of Disability Inventory (PEDI). The study aims to determine whether combining FES with CIMT provides greater improvements in motor recovery and daily functional performance in children with CP.
NCT06507631
Rationale: In 2010 Aarts developed the pirate group in which children received constrained induced movement therapy (constrained with a sling) followed by bilateral therapy. During this pirate group children were dressed as a pirate to increase motivation and to make the sling more meaningful. This pirate group had a duration of eight weeks with three times three hour training sessions each week. However, due to COVID-19 therapists were introduced to home-based rehabilitation. Therefore they developed the blended care pirate group, which is in principle the same as the pirate group of Aarts, however one training session each week is replaced by a home-based training session. It is however not yet clear how this blended care pirate group is perceived by parents and therapists. Objective: The aim of the current study is to investigate the feasibility and effectiveness of the blended care pirate group. Study population: Children with unilateral cerebral palsy between 2.5 and 8 years old will participate. These children will participate in the blended care pirate group and are asked to participate in the study as well. Intervention: The total duration of one blended care pirate group is eight weeks with two times three hour training sessions at the rehabilitation centre and additional training sessions at home. The training sessions on-site will be the same as the conventional pirate group. For the training sessions at home parents will receive instructions and material from the therapists. This intervention is developed and already planned by therapists without direct influence of the research department and can therefore be considered as standard treatment. Main study parameters/endpoints: The primary outcome are the total training hours performed by parents at home. Additionally after the blended care pirate group parents and therapists will participate in an interview about how they perceived the blended care pirate group. Secondary outcomes are improvements in arm function during the blended care pirate group.
NCT02391324
Robot assisted gait training is seen as a promising intervention for improving the walking abilities of children with cerebral palsy, but research to support its effectiveness compared to best practice physical therapy is lacking. This research consists of a randomized controlled trial (RCT) and a qualitative descriptive study that is linked with the RCT. The goal of the RCT is to compare: 1) a walking training program with the Lokomat® robotic device (LOK), 2) a functional physical therapy program (fPT) that includes activities to enhance balance/co-ordination/endurance and advanced motor skills conducted over 'real ground', 3) a combined Lokomat® + functional physical therapy (LOK+fPT) program, and 4) a regular maintenance therapy condition (CONT) for ambulatory children and youth with CP (aged 5- 18 years). The three intervention programs will consist of sixteen 50-minute sessions given twice weekly over 8 to 10 weeks. The primary objective of the RCT is to compare the four groups with respect to walking-related motor skills as measured by the Gross Motor Function Measure. The secondary objectives are to compare each intervention's impact on walking abilities, individualized goals, fitness, balance, physical activity levels, child's belief in ability to do physical activity, participation and quality of life. The investigators will also evaluate the extent of carryover or progress 3 months after the intervention. The qualitative part of the study will consist of interviews of children and parents after they have finished the study intervention. The information from the interviews will assist us with interpretation of the outcome results (areas of impact and amount of change) from the RCT. In particular, the interviews will 1) provide insight into their experiences with the trial interventions, 2) identify the mobility-related outcomes that are important to families and the factors that influence their preferences, and 3) explain the family values, experiences and contextual factors that influenced participation in the study. This research will provide information needed to allow clinicians and families to make informed choices about Lokomat therapy and physical therapy options in relation to their child's functional goals and abilities.
NCT01829724
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.
NCT07547644
The goal of this clinical trial is to determine whether virtual reality (VR) training using the Nintendo Wii Fit can improve balance, gross motor function, and agility in children aged 7-14 years with spastic cerebral palsy (GMFCS Levels I-II). The main questions it aims to answer are: Does Wii Fit-based VR training improve balance more than conventional physiotherapy? Does VR training enhance gross motor skills such as standing, walking, running, and jumping? Does VR training improve agility in children with cerebral palsy? Does VR training increase enjoyment and engagement during therapy? Researchers will compare Wii Fit-based VR training with conventional physiotherapy to determine which approach leads to greater improvements in motor function. Participants will: Attend 18 sessions over 6 weeks (3 sessions per week). Perform either VR-based exercises using the Wii Fit Balance Board or traditional physiotherapy exercises. Complete pre- and post-intervention assessments using the Pediatric Balance Scale, GMFM-88 (domains D and E), BOT-2 agility subtest, and the PACES enjoyment scale. This study aims to explore a fun, cost-effective, and engaging rehabilitation strategy that may improve functional independence and overall quality of life for children with cerebral palsy.
NCT06498596
Background: Cerebral palsy (CP) is the most common motor disorder that affects children. People with CP have weak muscles; they may have trouble controlling the movements of their arms and legs. Researchers have been developing braces called robotic exoskeletons for people with CP. These devices can adapt to the person s movements and help them move better. This natural history study will explore new technologies that may tell us more about how people with CP move and improve how these exoskeletons work. Objective: To test new technologies to measure people s movements and brain function while they move with and without a robotic exoskeleton. Eligibility: People aged 5 to 25 years with CP. Healthy volunteers are also needed. Design: Participants will have 3 to 5 clinic visits in 2 months. Participants will be fitted with an exoskeleton that will be worn on one of their legs. At each visit, participants will be asked to move their wrist, ankle, and knee while the following measurements are taken: Ultrasound. A bar will be placed against the skin. It will send soundwaves into the body to take pictures of the muscles. Electroencephalography (EEG). Participants will wear a cap with sensors. Their brain waves will be recorded. Electromyography (EMG). Small metal discs will be taped to the skin. They will measure electrical activity of muscle. Participants will flex and extend each joint (wrist, ankle, or knee) on one side of their body. These movements will be done on their own and while assisted by two devices: Functional electrical stimulation (FES). Small adhesive pads will be placed on the skin and electric. Pulses will stimulate muscles to help move the limb. This will be done for the wrist, ankle and knee. Robotic Exoskeleton. A leg brace will be placed on one limb with a motor that will help move the knee. The exoskeleton can be used with or without FES. Participants will also walk on a treadmill at their own pace. Photographs and videos will record how they move.
NCT07504640
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.
NCT07534228
To compare the efficacy of play-based therapy versus NDT in improving fine motor skills in children with Spastic Diplegic Cerebral Palsy. Baseline Assessments (Pre-Intervention) To Establish baseline motor function, balance, and goals. * Standardized Tools (Conducted in Week 1): * Peabody Developmental Motor Scales (PDMS-2): Evaluate gross and fine motor skills. * Modified Ashworth Scale: Assess spasticity in lower and upper limbs. * Pediatric Balance Scale (PBS): Measure static and dynamic balance. * Parent/Child Goal Setting: Identify individualized goals (e.g., stair climbing, dressing independence). 1\. Play-Based Therapy (PBT) * 5-Minute Warm-Up: Gentle play (e.g., rolling a ball, stretching with ribbons) * Building Blocks: Focus on fine motor control, bilateral coordination, and problem-solving. * Puzzles: Enhance spatial awareness, grip strength, and cognitive engagement. * Arts and Crafts: Promote hand-eye coordination (e.g., cutting, drawing) and creativity. * Frequency: 4 days a week, for 3 consecutive weeks * Intensity: Moderate effort; tasks tailored to the child's skill level (e.g., 5 piece puzzles progressing to 10-piece). * Time: 45-minute sessions (30 minutes active play, 10 minutes rest/reinforcement). 2. Neurodevelopmental Therapy (NDT) * 5-Minute Warm-Up: Light mobility exercises (e.g., Hand pumps, seated marching). * Resistance Bands: Strengthen upper limbs (e.g. Bicep curls, shoulder abduction, chest presses.). * Small Dumbbells: Improve upper body strength (1-2 lbs for shoulder/arm exercises). * Stress Ball Squeezes: Enhance grip strength and hand function (5-10 reps/session). * Frequency: 4 days a week, for 3 consecutive weeks * Intensity: Moderate resistance; emphasize alignment and controlled movement * Time: 40-minute sessions (30 minutes active exercise, 10 minutes rest/feedback). Outcome Measures * Peabody Developmental Motor Scales (PDMS-2): for evaluating fine motor skills. * Modified Ashworth Scale (MAS): To measure muscle spasticity (tone) in the limbs. * CHQ: To measure health-related quality of life
NCT07252713
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.
NCT07069257
This randomized, controlled, single-blind trial aims to investigate the effectiveness of neuromuscular electrical stimulation (NMES) combined with oral motor therapy in reducing drooling severity among children with cerebral palsy. Participants will be allocated to an intervention group (oral motor therapy plus NMES), a control group (oral motor therapy alone) and a sham group (oral motor therapy with placebo NMES).
NCT06454656
The goal of this clinical trial is to learn if a new therapy approach to improve walking ability in children with Cerebral Palsy is acceptable to the children and the families in a community setting. The main questions we look to answer are: 1. Do the children/teens tolerate the therapy and feel that it is helpful? 2. Do the parents/ families feel the therapy helps and is easy to commit to? 3. Do the children/teens complete all their therapy sessions and assessments as planned? The participants will trial the therapy for 30 hours over 6 weeks and will perform assessments before and after to see if they meet their goals. They will also be interviewed to see how they felt about the therapy when they finish.
NCT07521384
This prospective observational study collects real world data on participants receiving regenerative therapies administered internationally and delivered intranasally via the Kurve Therapeutics ViaNase device. The study does not assign treatment. Participants are enrolled after receiving, or electing to receive, therapy as part of routine clinical care outside the study. Participants are observed in one of three cohorts based on the therapy received: MuSE cell derived exosomes, MuSE stem cells, or combination therapy. The objective is to evaluate safety, tolerability, and changes in inflammatory biomarkers and clinical outcomes over time in a real world setting. The study also evaluates changes in inflammatory biomarkers, including serum tumor necrosis factor alpha (TNF-α), to better understand the biological effects of these therapies.
NCT07518511
PURPOSE: This study evaluated the effectiveness of a Sensory-Enhanced Home-based Intensive Program (SE-HIP), delivered via asynchronous video guidance, compared to a Standard Home Program (SHP) on improving upper limb function in children with cerebral palsy (CP). BACKGROUND: Children with cerebral palsy (CP) often have upper limb (UL) impairments that limit daily life and participation. Intensive, repetitive therapy is crucial, but traditional delivery has limitations. Home-based programs supported by tele-rehabilitation offer increased dosage and accessibility. Asynchronous models delivered via video guidance are flexible but are less studied for intensive upper limb therapy. Sensory processing deficits are common in cerebral palsy; integrating sensory enhancement may augment motor learning. Evidence combining sensory-enhanced intensive upper limb programs delivered asynchronously is lacking. HYPOTHESES: The investigators hypothesized that children receiving the Sensory-Enhanced Home-based Intensive Program (SE-HIP) would demonstrate significantly greater improvements in primary upper limb functional outcomes, measured by the Box and Block Test (BBT) and the Nine-Hole Peg Test (NHPT), compared to those receiving the Standard Home Program (SHP). RESEARCH QUESTION: Does a sensory-enhanced, asynchronous video-guided home program lead to significantly greater improvements in upper limb function (manual dexterity measured by the Box and Block Test (BBT) and the Nine-Hole Peg Test (NHPT)) compared to a standard video-guided home program in children with cerebral palsy (CP)?
NCT07506837
This interventional study will evaluate the effects of an intensive HABIT-ILE-based camp on cardiorespiratory measures and body composition in children with cerebral palsy. Although intensive motor control-based therapies such as HABIT/HABIT-ILE have shown functional benefits, the novelty of this study is the assessment of energy expenditure during functional tasks and post-intervention changes in body composition. Participants will attend a summer camp-format intervention delivering 90 hours of upper and lower extremity training over 15 days (6 hours/day), supervised by trained rehabilitation staff in a playful, progressive group setting. The program includes bimanual activities, gait and stair tasks, functional strengthening, and whole-body games, with fatigue prevention strategies.Assessments will be performed at baseline and immediately after the camp in July 2027, with follow-up at 6 months (January 2028). Outcomes include functional performance, parent-reported function, low-intensity task-related energy expenditure measured in a physiology laboratory, and body composition measured by DEXA at Universidad Europea de Madrid
NCT05644652
Nordic walking is a physical activity consisting of walking with poles similar to ski poles. The poles are designed for the purpose of activating the upper body during walking. The poles are equipped with rubber or spike tips and the walking itself resembles.
NCT07488429
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
NCT06585618
There is limited data on outcomes for children who have undergone deep brain stimulation (DBS) for movement disorders, and individual centers performing this surgery often lack sufficient cases to power research studies adequately. This study aims to develop a multicenter pediatric DBS registry that allows multiple sites to share clinical pediatric DBS data. The primary goals are to enable large-scale, well-powered analyses of the safety and efficacy of DBS in the pediatric population and to further explore and refine DBS as a therapeutic option for children with dystonia and other hyperkinetic movement disorders. Given the current scarcity of evidence available to clinicians, this centralized multicenter repository of clinical data is critical for addressing key research questions and improving clinical practice for pediatric DBS.
NCT04630392
Whole-body vibration (WBV) and treadmill training (TT) are commonly-utilized rehabilitation interventions for children with neuromotor disorders. WBV has been shown in the literature to positively affect gait and lower body spasticity in this population. However, the effects of a single session of WBV are generally transient, lasting between ten minutes and two hours. Thus, it may be necessary to combine WBV with another intervention to reinforce improved movement patterns and maximize its potential benefits. Therefore, the aim of this study is to investigate the effects of the addition of a single bout of WBV to a single bout of TT on the lower extremity spasticity and gait parameters of ambulatory children with CP.
NCT07466914
Constipation is a common problem in children with cerebral palsy and may negatively affect daily activities, quality of life, and family well-being. Several factors such as nutrition, physical activity level, functional status, and psychological condition of the caregiver may be associated with constipation in this population. The aim of this study is to investigate the presence and severity of constipation in children with cerebral palsy and to examine the factors that may be related to constipation, including dietary intake, fluid consumption, physical activity level, functional status, and caregiver psychological status. This study is an observational cross-sectional study including children with cerebral palsy aged 4-18 years and their caregivers. Data will be collected using questionnaires, clinical classification systems, bowel diaries, nutrition records, and psychological scales. No intervention will be applied to participants.
NCT06268223
This study is a two-part randomized controlled trial designed to investigate the effects of home-based Action Observation Training (AOT) combined with Functional Chewing Training (FuCT) in children with Cerebral Palsy (CP) who have chewing disorders. In Part I, the primary outcome results-chewing function, swallowing function, and feeding behaviour-will be reported. In Part II, the secondary outcome results, including child participation, quality of life, and caregiver impact, will be presented. Within the scope of the study, children with CP will be randomly allocated to either a study group or a control group. Both groups will receive FuCT (5 sets per day, 5 days per week, for 12 weeks). In addition, the study group will participate in a home-based AOT program delivered via telerehabilitation (1 set per day, 3 days per week, for 12 weeks) under the guidance of a physiotherapist. All participants will be assessed at baseline, at week 6, and at the end of week 12.