Clinical Research Directory

Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach)

Children with disabilities often access rehabilitation services to improve their abilities to participate in everyday activities. Goal-directed therapy is considered an important therapeutic strategy to achieve outcomes that are meaningful to families. Not a lot is known about the effects of goal setting on rehabilitation outcomes. Strategies to help children participate in the goal-setting process are rarely used in clinical practice. The aim of this project is to test the effects of a child-focussed goal setting approach, Enhancing Child Engagement in Goal Setting (ENGAGE), on therapy outcomes. Service use and the cost vs. benefits of the ENGAGE approach compared to usual practice will also be examined. Children with neurodevelopmental disabilities aged 5-12 years old (n=96) who access paediatric rehabilitation services at six rehabilitation sites will participate. Therapists (n=24) at participating sites in Alberta, Canada will be randomized into 1) the ENGAGE intervention group or 2) the usual therapy practice control group. Children will participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. This study will determine if the ENGAGE approach to goal setting affects child goal performance, satisfaction with goal performance, functional abilities, participation, and parent and child quality of life. The investigators will also evaluate differences in parent and child quality of life in relation to parent costs (e.g., absenteeism, presenteeism, travel costs) and compare amount of therapy time between the two groups to see which approach is more cost-effective and efficient. After the study, children, parents and therapists will be asked to discuss aspects that influenced effective implementation of the ENGAGE approach. This study could provide evidence to improve meaningful child and family outcomes in paediatric rehabilitation and improve efficiency of paediatric rehabilitation services.

Assessing Transition Practices for Children With Disabilities: Pathways to a Successful Adulthood

Transition to adult care is a purposeful and structured movement of youth with complex disabilities from child centered to adult oriented services. This complex and potentially challenging period requires careful planning. The investigators aim to examine the transition practices in the University Hospital of Saint Etienne. The study employs a mixed methods approach, combining: * A retrospective evaluation : Analyzing transition data over a 10-year period. * A prospective qualitative study : Conducting semi-structured interviews with patients who have already transitioned within our clinic.

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.

Non-Invasive Measurement of Pulmonary Dysfunction in Children With Cerebral Palsy

This proposal addresses pulmonary dysfunction in severe cerebral palsy by using a novel non-invasive respiratory sensor. The two aims of the project are to 1) provide a screening tool to detect respiratory distress and 2) Find a correlation between the degree of pulmonary dysfunction and scoliosis in children with cerebral palsy.

Effects of Proprioceptive Neuromuscular Facilitation and Task-Oriented Training on Upper Extremity Function in Children With Spastic Diplegic Cerebral Palsy

Children with spastic diplegic cerebral palsy often experience upper extremity impairments, including reduced coordination, muscle control, and functional hand use, which limit independence in daily activities. Proprioceptive Neuromuscular Facilitation (PNF) and Task-Oriented Training (TOT) are commonly used rehabilitation approaches to improve motor function; however, evidence comparing their individual and combined effects on upper extremity function remains limited. This randomized controlled trial aims to compare the effects of PNF alone, TOT alone, and a combined PNF plus TOT intervention on upper extremity function in children with spastic diplegic cerebral palsy. Sixty-three children aged 6 to 12 years with Gross Motor Function Classification System (GMFCS) levels I to III will be randomly assigned to one of three intervention groups. Each group will receive supervised 45-minute treatment sessions, three times per week for six weeks. Upper extremity function, functional independence, and joint range of motion will be assessed at baseline, mid-intervention (3 weeks), and post-intervention (6 weeks) using the Melbourne Assessment of Unilateral Upper Limb Function (MA2), Pediatric Evaluation of Disability Inventory-Functional Skills Scale (PEDI-FSS), and goniometric measurements. The findings of this study are expected to provide evidence regarding the most effective rehabilitation approach for improving upper extremity function in children with spastic diplegic cerebral palsy.

Influence of Hawthorne Effect and Dual-tasks on Gait in CP

It is the clinical experience of the authors that some children with cerebral palsy who walk in crouch gait show sufficient knee extension during the clinical gait analysis, but walk in considerable knee flexion when they leave the gait laboratory. Possible differences between walking in a gait lab and walking in daily life may be caused by the effect of observational awareness in the lab (also known as the Hawthorne effect), and the lack of dual-tasks (DT) during the analysis (which are common during daily life walking). Since so far there is no technique to reliably measure gait kinematics in children with CP outside of the laboratory, the researchers aim to objectify the influence of both the Hawthorne effect and dual-tasks by introducing different conditions during a standard clinical 3D gait analysis.

Robot-assisted Training in Children With CP

Cerebral palsy (CP) is the most common physical disability in early childhood causing serious motor and sensory impairments. Effective interventions for the recovery of motor functions are of profound significance to children with CP, their families, caregivers, and health professionals. Robot-assisted rehabilitation represents a frontier with potential to improve motor functions and induce brain reorganization in children with CP.

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.

Upper Extremity Sensation and Function in Children With Cerebral Palsy

This cross-sectional study was designed to evaluate upper extremity sensation in children with spastic cerebral palsy and to investigate its effect on upper extremity use in activities of daily living. Children aged 6-15 years with cerebral palsy (n=15) and typically developing peers (n=15) who volunteer to participate in the study will be included. Participants' sociodemographic data will be recorded, and upper extremity vibration sense, stereognosis, tactile sense, two-point discrimination, and joint position sense will be assessed. In the final stage, the Jebsen Taylor Hand Function Test will be administered, and parents will be asked to complete the Abilhand Kids Hand-Related Ability Scale.

Retrospective Study of Intensive Therapy Pathways in Children With Cerebral Palsy (P'TI-PARCOURS)

This retrospective single-center study aims to describe the care pathways of children with unilateral cerebral palsy (hemiplegia) who participated in intensive therapy programs (COLHEMI and/or Mini-COLHEMI) at the Centre des Massues since January 2010. The COLHEMI program (launched in 2010, for children aged 6-12) provides 70 hours of intensive motor learning-based therapy over 2 weeks, while the Mini-COLHEMI program (launched in 2020, for children from age 2) provides 30 hours over 2 weeks. The study will describe the immediate and medium-term impact of these programs on bimanual performance (Assisting Hand Assessment, AHA) and individualized goal attainment (Goal Attainment Scaling, GAS), analyze their impact on bimanual developmental trajectories using all available AHA scores, identify characteristics of good responders, and describe parent satisfaction. Approximately 75 patients will be included. Data are collected retrospectively from electronic and paper medical records by an occupational therapist.

A Gamified Breathing and Postural Awareness Education Model for Children With Cerebral Palsy

This project aims to develop an accessible, learning-oriented model based on gamified breathing and posture training that emphasizes active participation for children with cerebral palsy (CP), their families, and educators. Since current practices are largely clinic-centered, there is a growing need for game-based, motivational and widely discernible programs. In this context, the project aims to provide an inclusive model that enhances breathing and postural awareness through digital technology, thereby increasing motivation and adherence.

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.

Functional Progressive Resistive Training and Cerebral Palsy

Functional Progressive Resistive Exercise (FPRE) is a strengthening approach that combines functional movement activities with progressively increased resistance. It involves performing task-oriented exercises, such as sit-to-stand, stair climbing, and walking-related activities, while gradually increasing the load to enhance muscle strength, endurance, and functional performance. FPRE is widely used in rehabilitation programs to improve mobility and the ability to perform activities of daily living in various populations, including children with neurological and musculoskeletal disorders.

Aquatic Therapy for Children With Neuromotor Deficits

The purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention for children ages 3-9 with neuromotor deficits such as cerebral palsy. The intervention takes place in a warm water therapy pool, twice a week for ten weeks and targets swim safety skills, upper extremity function and self care participation and performance.

Locomotor Learning in Infants at High Risk for Cerebral Palsy

The objective of this project is to characterize the evolution of locomotor learning over the first 18 months of life in infants at high risk for cerebral palsy (CP). To characterize how locomotor skill is learned (or not learned) during this critical period, the investigators will combine established protocols using robust, unbiased robotic and sensor technology to longitudinally study infant movement across three consecutive stages during the development of impaired human motor control - early spontaneous movement, prone locomotion (crawling), and upright locomotion (walking).

Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy

The investigators hope to use MRI biomarkers to identify and characterize sensorimotor network disruption patterns associated with chronic pain and sensory deficits in CP. Investigators will use existing information in the medical record as well as subjective reports from interview, physical exam data, and anatomical and functional MRI data to non-invasively identify brain injury correlates of pain and sensory deficits.

Comparative Effect of CIMT and PNFTechnique on Hands Dexterity in Cerebral Palsy

Cerebral Palsy (CP) is a group of permanent disorders of the development of movement and posture, causing activity limitations that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. The primary motor impairments in CP often include issues with muscle tone, reflexes, and coordination. Among the various motor disorders associated with CP, impairment of the upper extremities is particularly common and functionally debilitating. Specifically, reduced hand dexterity the ability to perform coordinated, fine motor tasks significantly impacts a child's independence in daily activities such as feeding, dressing, and school-related tasks like writing. Therefore, improving hand function is a critical goal in physiotherapy for this population The objective of this study was to compare the effectiveness of a constraint induced movement therapy ( CIMT ) and Proprioceptive neuromuscular facilitation technique on dexterous movement of hands in cerebral palsy .The study design will be Randomized Controlled Trail. The study setting will be Pediatric Rehabilitation Center or Physiotherapy Department. The duration of study will be 10 months after approval of synopsis. The sample size will be 20 which is calculated by epitools. The sampling technique will be Non-probability convenient sampling . Children who are diagnosed with cerebral palsy will be included. Children with other musculoskeletal and neurological issues will be excluded. Data Collection Tools will be Box and Block test and Pediatric Evaluation of Disability Inventory.. The data will be analyzed using SPSS 23. Keyword Cerebral Palsy, Constraint induced movement therapy (CIMT), dexterous movement, Proprioceptive neuromuscular facilitation

Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy

The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of a sensorimotor intervention (SMI) provided in the first 6 months of life for infants with hypoxic-ischemic encephalopathy.

Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy

TABLO (Tranexamic Acid to reduce Blood Loss after varus derotation Osteotomy) is a clinical trial of postoperative tranexamic acid vs placebo in non-ambulatory children with cerebral palsy (CP) undergoing reconstructive hip surgery. Improving surgical outcomes is a high priority in this patient population given the high risk of bleeding and the diminished capacity for these children to withstand substantial blood loss. Preliminary data from the study institution indicates that approximately one third of these patients receive transfusion of blood products in the postoperative period. There is growing evidence that hidden blood loss occurring in the postoperative period is substantial and can potentially be attenuated with the administration of Tranexamic Acid (TXA). However, trials on postoperative TXA have been carried out exclusively in adult surgical populations.

Upper Extremity Function, School Performance, and Academic Success in Children With Cerebral Palsy

The aim of this study is to investigate the relationship between upper extremity functionality and school-related outcomes, including academic achievement, school performance, and perceived academic success in school-aged children with cerebral palsy. The study specifically aims to evaluate how upper extremity motor function is associated with academic participation and school-based functional performance. The main hypotheses are: H0: There is no significant relationship between upper extremity functionality and academic achievement, school performance, and perceived academic success in school-aged children with cerebral palsy. H1: There is a significant relationship between upper extremity functionality and academic achievement, school performance, and perceived academic success in school-aged children with cerebral palsy.

Investigating New Methods to Study Movement in Children and Young Adults With Movement Disorders.

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.

Robotic Exoskeleton Gait Training for Children With Cerebral Palsy

The goal of this clinical trial is to evaluate whether robotic-assisted gait training can improve motor function, walking capacity, joint flexibility, muscle structure, and psychological well-being in children aged 6 to 12 years with spastic cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) level IV. The main questions it aims to answer are: Can robotic gait training improve gross motor function and walking ability in children with GMFCS level IV CP? Does robotic training enhance joint range of motion, muscle morphology, and psychological satisfaction in this population? Researchers will compare a robotic gait training group to a usual care group to see if the robotic intervention leads to better physical and psychological outcomes. Participants will: Be randomly assigned to receive either robotic gait training or continue their usual care for 6 months Complete three 45-minute training sessions per week (robotic group only) Undergo physical and psychological assessments at the beginning, midpoint, and end of the study Have their gross motor function, walking ability, joint flexibility, muscle structure, and quality of life measured using validated tools

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

Pilot Study on the Validity, Tolerability, and Impact of a Walking Rehabilitation Intervention Using Cruro-Malleolar Cast in Children With Cerebral Palsy

This pilot study investigates whether walking training using cruro-malleolar casts (CMCs) - rigid leg splints extending from the thigh to the ankle - can safely improve gait quality in children with bilateral cerebral palsy (CP). CMCs are already used in routine clinical care at our center, but their biomechanical effects and therapeutic value have never been formally studied.Children aged 7 to 14 with bilateral spastic CP (diplegia or quadriplegia, GMFCS levels I-III) will participate in a 4-week treadmill walking program wearing CMCs, preceded by a 1-month observation baseline and followed by a 6-month follow-up. The investigators will use motion capture technology and surface electromyography to measure how the CMCs immediately change the way children walk - particularly at the hip and pelvis - and whether the training program leads to lasting improvements in walking speed, quality, and endurance.The study also carefully monitors pain and effort perceived by children during each training session, so that tolerance of the intervention can be rigorously assessed. Six participants will be enrolled. The study uses a Single-Case Experimental Design (SCED), which allows rigorous conclusions to be drawn from a small number of patients through repeated measurements over time.