Clinical Research Directory

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.

Evaluation of the NEUROSWING Orthosis on Walking Speed in a Population With Dorsal and/or Plantar Flexor Deficits, With a View to a Reimbursement Application

The aim of this randomized, cross-over, multi-center, intention-to-treat, open-label study study is to determine the benefits of the NEUROSWING device on gait speed in patients with dorsal and/or plantar flexor deficits, compared with the use of a carbon orthosis. Each patient will benefit in random order from a 14-day investigation period with the NEUROSWING device and a 14-day control period with a carbon orthosis. These two 2-week periods will be separated by one week, during which no orthosis will be worn and no evaluation will be carried out. Patients will be randomized to determine which phase they will start with. The primary endpoint is walking speed, which will be measured by comparing the results of the 10-meter walk test. For the secondary endpoints, patients will be assessed using the Functional Gait Assessment (FGA), the 6-minute test and an analysis system that will analyze other gait parameters (duration of the different phases of the gait cycle, cadence and step length). In order to carry out the assessments, each patient included will have 12 visits spread over 5 weeks.

The Effects of Protocolized Breathing Exercises on Pulmonary Function in Adolescents With Cerebral Palsy.

This multicenter randomized controlled pilot trial evaluates whether an 8-week protocolized breathing exercise program improves pulmonary function and quality of life in adolescents and young adults with cerebral palsy. Participants are randomized to either a structured breathing exercise program added to usual pedagogical rehabilitation care or sham breathing exercises plus usual care. The study assesses changes in spirometric outcomes (FVC, FEV₁, PEF) and patient-reported quality of life and emotional well-being. Participants complete respiratory assessments and questionnaires at baseline, post-intervention, and follow-up.

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.

Comparative Study of Augmented Reality and Virtual Reality in Music Therapy Interventions for Individuals With Cerebral Palsy

The goal of this clinical trial is to compare the user experience of Augmented Reality (AR) and Virtual Reality (VR) applications during music therapy interventions in individuals with Cerebral Palsy aged 15 to 35 years with Gross Motor Function Classification System (GMFCS) level I-V. The main questions it aims to answer are: Does AR or VR result in lower levels of cybersickness as measured by the Simulator Sickness Questionnaire (SSQ)? Does AR or VR provide better usability, preference, and perceived ease of interaction? Researchers will compare AR and VR conditions to determine which technology results in lower cybersickness levels, higher usability scores, and greater user preference. Participants will: complete a pre-intervention SSQ assessment; engage in AR and VR sessions in a counterbalanced order using the Meta Quest 3 headset; explore each virtual environment for 5 minutes; perform motor tasks involving reaching and interacting with virtual musical objects (musical cubes representing musical notes: C-D-E-F-G-A-B); perform cognitive tasks involving identification and reproduction of musical note sequences guided by a therapist; perform percussion activities by following rhythmic patterns played by a therapist using virtual instruments; complete post-condition assessments after each session, including SSQ, System Usability Scale (SUS), preference, and reported difficulties.

Orthosis to Improve Trunk Control in Infants Age 6-18 Months

The purpose of this study is to determine the impact of the SPIO® Core-MAX® Expedition orthosis on an infant's head, trunk and upper limb function.

Telehealth Virtual Reality Gaming on Cardiometabolic Health Among Youth With Cerebral Palsy

The primary purpose of this study is to examine the preliminary efficacy of 12-weeks of home-based exercise using consumer available virtual reality gaming technology, compared with a 12 week wait-list control group. The secondary purpose is to understand behavioral mechanisms that explain participation in exergaming through semi-structured interviews with participants from both groups at post-intervention or dropout.

Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use

This observational study aims to compare sleep quality, caregiver burden, stress, and self-efficacy between parents of children with spastic diplegic cerebral palsy who use night orthoses and those who do not. Approximately 150 parents will be included and divided into two groups according to their children's night orthosis use. The study will investigate whether night orthosis use is associated with differences in parental sleep quality, caregiver burden, stress, and self-efficacy.

Rehabilitation and Treatment Utilization in Children With Cerebral Palsy: Analysis of the Korean Cerebral Palsy Registry

This cross-sectional observational study analyzed baseline data from 836 children with cerebral palsy enrolled in the Korean Cerebral Palsy Registry (KCPR), a nationwide multicenter prospective registry involving 42 institutions in South Korea. The study examined rehabilitation and treatment utilization and evaluated socioeconomic and geographic factors associated with patterns of rehabilitation service use and cerebral palsy-related management. No intervention was assigned as part of this study.

Acceptability and Efficacy of GO MOVE

The goal of this clinical trial is to learn about the acceptability and efficacy of Go Move, a mobile website developed to assist youth with unilateral cerebral palsy and their caregivers with setting goals and selecting exercises and activities to meet the goals. The main question\[s\] it aims to answer are: * Is Go Move accepted by youth with unilateral cerebral palsy and their caregivers? * Does Go Move support goal attainment for youth with unilateral cerebral palsy? Participants will set up and participate in a goal-driven home program using the Go Move mobile website. Participants will spend 1 hour and 15 minutes per week for 6 weeks working on their home program and will complete pre-intervention and post-intervention assessments.

Implementation of Therapy Together

The goal of this clinical trial is to learn about the implementation of Therapy Together, a pediatric constraint-induced movement therapy program in young children with unilateral cerebral palsy. The main question\[s\] it aims to answer are: * Is the Therapy Together program effective in improving hand function and occupational performance compared to usual care? * Is it feasible to implement the Therapy Together program within the standard care, early intervention framework? Participants will participate in an 8-week pediatric constraint-induced movement therapy program. Researchers will compare the group completing the Therapy Together Program to a group that is receiving usual care to see if there is a difference in the change in hand function, occupational performance, and development.

Chronic Postsurgical Pain

The study purpose is to document the typical trajectory of perioperative pain experience in Cerebral Palsy (CP) and to identify important predictive factors for the development of chronic postsurgical pain. The main aims of the investigators are to: 1. Quantify the trajectory of pain and opioid use in the context of orthopedic surgery in children with CP. 2. Identify predictors for CPSP in children with CP and develop an applicable risk index. 3. Examine relationships between perioperative pain severity and functional/mobility outcomes achieved by orthopedic surgery in children with CP. Participants will complete: 1. Questionnaires/Surveys via email and text message 2. In-person Sensory Tests 3. In-person Gait and Motion Analysis

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.

Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game

The aim of this pilot study is to evaluate muscular activity during a single session of surface electromyography controlled exergame (muscle activation, number of contraction…) in cerebral palsy kids, hemiparetic adults and healthy controls. Secondary aims are to assess different game mode (one-player, coactive two-player or competitive two-player and different gameplay (a rhythm and a platform gameplay) on muscle activation, number of contraction and on participant's experiences. Another aim is to assess enjoyment, motivation, flow and usability in hemiparetics adults.

Sensory-Motor Integration Versus Virtual Reality-Based Exercise in Children With Cerebral Palsy

This study aims to compare the clinical effects of a sensory-motor integration-based exercise program and a virtual reality-based exercise program on gross motor function, balance, and functional mobility in children with cerebral palsy. Participants will be randomly assigned to one of two groups. Both groups will continue to receive standard conventional physiotherapy. In addition, one group will receive a structured sensory-motor integration-based exercise program, while the other group will receive a Nintendo Wii Sports-based virtual reality exercise program. The intervention period will last 16 weeks, with two sessions per week. Outcomes will be assessed before and after the intervention using standardized clinical measures.

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.

Spinal Stimulation and Mobility Devices

This research study will combine non-invasive spinal stimulation with an ankle exoskeleton to examine the acute impact of the stimulation on gait in children with cerebral palsy.

VR Versus Plyometric Exercise on Lower Limb Motor Control and Balance in Spastic Hemiplegic Children

To investigate and compare the effect of Virtual reality and Polymetric exercises on balance, selectivity of the lower extremity and quality of life in children with spastic cerebral palsy. BACKGROUND: Cerebral palsy (CP) can cause a variety of musculoskeletal issues that impact everyday functioning and activities including reduced balance and selective motor control thus improving balance, selective motor control, and quality of life represents a primary goal of pediatric rehabilitation. Various therapeutic interventions have been introduced to enhance lower limb function however, evidence comparing the effectiveness of different treatment approaches remains limited.

The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes

The objective is to explore the potential short and long-term impact of the EXOPULSE Mollii Suit and EXOPULSE Suit on subjects with CP, MS, stroke, fibromyalgia or other neurologic disorders which may cause such types of symptoms, and to identify high responders among the sub-categories of the diagnoses. The primary endpoint will be improvements in the Berg/Pediatric Balance Scale (BBS/PBS) as a measurement of balance and risk of falls.

Using Power Mobility Training to Promote Arm & Hand Function in Children With Cerebral Palsy

Approximately 40% of children with ambulatory cerebral palsy have significant functional asymmetries in arm and hand function. Children with these significant functional asymmetries have difficulties using their more-affected (less preferred) arm and hand in daily activities, especially true in daily activities requiring bilateral hand and arm use. Recent research suggests that power mobility training provided via a ride-on toy may help to motivate these children to use their less preferred arm and hand. This research further notes that participation in power mobility training designed to encourage a child to use their less preferred arm and hand also may help to improve their arm and hand function and use in their daily activities. This exploratory study seeks to explore an innovative intervention using arm- and hand-use focused power mobility training activities, encompassing both navigational/maneuvering activities and embedded play-based reaching and grasping activities. During power mobility training activities, children will be asked to wear a soft mitten or sock on their preferred hand to help them remember to use their less preferred hand and arm. The purpose of this exploratory study is to examine both the effect and feasibility of a 6-week laboratory-based arm-and hand-use focused power mobility training program.

Arm Motor Control on Bi and Uni ADLs

This study is being performed to assess how certain chronic disabilities - stroke, upper extremity (UE) amputation, spinal cord injuries (SCI), cerebral palsy (CP) - differ from healthy subjects in their ability to perform ADLs. By studying the kinematics of the respective cohort of study participants as they are assessed performing common activities of daily living (ADLS), the investigators research team aims to better understand how impaired neural pathways, and pathways that have been impaired at various points along the pathway, deleteriously affect ADLs in patients with differing long-term disabilities.

Therapeutic Listening for Balance and Trunk Control in Children With Cerebral Palsy

This study evaluates whether adding Therapeutic Listening to a structured physiotherapy program can improve balance, trunk control, and reaction time in children with spastic diplegic cerebral palsy. Children with spastic diplegic cerebral palsy may have difficulties with balance, trunk stability, and responding quickly to sensory cues. In this study, children will receive a structured program including core stability, balance, and reaction-time exercises. One group will receive the exercise program alone, while the other group will receive the same program together with Therapeutic Listening delivered through headphones during the exercise sessions. The study will compare changes in balance, trunk control, and auditory reaction time between the two groups after 8 weeks of treatment. The study aims to determine whether Therapeutic Listening provides additional benefits when combined with conventional physiotherapy.

Effect of Nordic Walking Versus Treadmill Training on Gait Asymmetry in Children With Unilateral Cerebral Palsy

Children with hemiparesis show characteristic walking pattern resulting from weakness and spasticity on one side of the body. Nordic walking (NW) engages both the upper and lower body, which can help improve coordination and balance.

The Impact of Community-based Wellness Programs on The Triple Aim

People with disabilities experience a staggering incidence of secondary conditions that can result in death or negatively impact their health, participation in the community, and quality of life. Many of these chronic secondary conditions are preventable. The Institute for Healthcare Improvement has advocated for optimizing care through programs that simultaneously improve health and the patient experience of care, while reducing cost, called the "Triple Aim." Studies have shown that the Triple Aim can be achieved through programs that facilitate community integration; however the U.S. healthcare system lacks a paradigm of care for individuals with disabilities that promotes community integration. In order to identify potential models of healthcare delivery for individuals with disabilities that are effective in achieving the Triple Aim, we will conduct a rigorous research project to evaluate the impact of two different models of care on the Triple Aim: 1) a community-based care management program delivered by a non-profit organization through waiver funds, and 2) the Program for All-inclusive Care for the Elderly (PACE) applied to younger individuals with disabilities between ages 55-64.