Clinical Research Directory

AI-based Model for Rehabilitation Engagement and Motor Performance Evaluation in Pediatric Patients

What is the purpose of this study? This study wants to learn how the physiological signals and movement data can help researchers understand and predict how children with neuromotor impairments engage with rehabilitation. Who can take part? 40 participants between 5 and 17 years old will take part. Half of them will be children with neurotypical development (control). The other half will be children with neuromotor impairments. What will happen in the study? Children within the control group will take part in 1 rehabilitation session, while those with neuromotor impairments will take part in 2 to 3 rehabilitation sessions as part of the treatment plan already provided by their referring physicians. During each session, researchers will collect: (i) physiological signals like heart activity (ECG), heart rate variability (HRV), and electrodermal activity (EDA); (ii) movement data; (iii) exergames scores and motor performance data; (iv) questionnaires filled out by therapists to understand how engaged the participant is. Children will use one of two technology-assisted rehabilitation systems during their sessions: either the Lokomat (robotic exoskeleton that supports children with impairments in walking) or the GRAIL system (a treadmill system with motion tracking and extended reality). Why is this study important? Researchers will use the data to understand and predict how each child responds to therapy and engage with it. These analyses will help therapists adjust rehabilitation settings in real-time, offering more personalized and effective care for children with neuromotor impairments.

Clinical Impacts of Structured Robotic Gait Training Programs

Background and Rationale: Walking impairments impacts the 2-3/1000 children who have cerebral palsy1,2, and others unable to walk due to other central nervous system disorders such as a traumatic brain injury. The impacts of this and related impairment impact all aspects of life. The lifelong costs of these is staggering in terms of dollars (over $1 million/child) and health adjusted life years (\~half compared to typically developing populations despite only slightly shorter lifespans). Yet there are currently no effective interventions to treat the fundamental balance impairment that underlie these problems4,5. Early use of robotic gait trainers have shown many benefits6,7, however access to these trainers is limited due to cost, availability, and ease of use within the home. Currently, there are a few options for an overground robotic gait trainer supported by the stability of a walker. The Trexo, is an option designed for use at home or in a community settings, but barriers to access mean that access to this therapy is out of reach for many people who may see benefits. Research Questions and Objectives: The aim of this study is to (a) evaluate the feasibility of a clinical robotic gait training program and (b) evaluate the effectiveness of these types of programs in achieving patient, family, and therapist goals. The study will examine adherence to a structured training program to determine if training with a robotic gait trainer in a hospital setting is feasible for the entire length of the designed training program. Goals will be set, a re-evaluation of these goals will be completed following the training program to determine whether or not the clinical program of robotic gait training was successful in helping patients reach the goals set out at the beginning of the program.

The FBRI VTC Neuromotor Research Clinic

The FBRI VTC Neuromotor Research Clinic was established and opened in May of 2013 to provide intensive therapeutic services to individuals with motor impairment secondary to neuromotor disorders. It is direct by Dr. Stephanie DeLuca and based on the principles surrounding ACQUIREc Therapy. ACQUIREc Therapy is an evidenced-based approach to pediatric constraint-induced movement therapy, which refers to a multi-component form of therapy that is focused on helping children who have asymmetric motor abilities between the two sides of the body. Historically, ACQUIREc Therapy has the unimpaired or less impaired upper extremity constrained (by a cast or a splint) while also receiving active therapy from a specially trained therapist who shapes new skills and functional activities with the child's more impaired upper extremity but who is also a licensed Occupational or Physical Therapist (OT/PT). Therapy dosages are high much higher than tradition OT or PT - often lasting many hours per day, up to 6 hours a day, 5 days a week, for 2-4 weeks. Investigators have developed further treatments based on the same principles of intensive services combined with behavior shaping for other areas of the body that are also affected by weakness (e.g., the leg and trunk) also, but which usually do not involve constraint. These have been more generally labeled ACQUIRE Therapy. All forms involve intensive, play-based therapy for children with asymmetric motor impairments of the arms and hands. The primary focus of treatment is to facilitate the acquisition of new motor skills in the child's weaker body parts through high levels of intensive therapy using scientifically-based behavioral guidelines. Therapy is also delivered in naturalistic environments. ACQUIREc Therapy as a treatment method has been tested in two randomized controlled trials, and a specific manual for its implementation has been developed. Dr. (s) Ramey and DeLuca previously founded a similar clinic, The Pediatric Neuromotor Research Clinic, at the University of Alabama at Birmingham where Dr. DeLuca directed the research clinic for 13 years and oversaw the implementation of the ACQUIREc Therapy treatment protocol in more than 400 cases. This research will involve analyzing and interpreting the clinical data of children going through clinical procedures at the FBRI VTC Neuromotor Research Clinic. All participation is voluntary and no children will denied services if families choose not to participate.

PT for Montana Children With NMD Using Hippotherapy and the Equine Environment

The goal of this pilot clinical trial is to determine if physical therapy incorporating horses can improve the motor skills of the arms in children 6-17 years old with neuromotor disorders (such as cerebral palsy, spinal muscular atrophy, or spina bifida) compared to standard play-based physical therapy. The main questions it aims to answer are: 1. Is the study protocol feasible and acceptable for participants, that investigators could apply them to a larger trial? 2. Do participants make improvements toward their goals for motor function, arm use, and participation in life situations following treatment, and is it different between the experimental and comparative intervention groups? 3. What are the physiological, behavioral, and emotional responses of children receiving physical therapy incorporating horses, versus those receiving standard physical therapy? Researchers will compare the experimental group who receive physical therapy incorporating horses to the comparative intervention group who receive standard play-based physical therapy to see if there is a difference in outcomes. Participants will complete a pre- and post-intervention assessment of their motor function and participation in life situations. Participants will receive physical therapy twice a week for 8 weeks for the intervention. In both groups, physiological, behavioral, and emotional responses to the interventions will be measured in 4 total sessions, 1 each at weeks 2, 4, 6, and 8.

Multicenter Study That Offers New Solutions for Paediatric Rehabilitation by Proposing a Rehabilitation Plan Based on Each Child's Needs Using New Technological and Robotic Devices, Combined Among Them.

The goal of this clinical trial is to demonstrate the efficacy of multi domain robotic and technological rehabilitation on everyday life and satisfaction in children with neuromotor conditions. The main questions it aims to answer are: * Will we have significant changes using the COPM in children taking part in the sperimental group? * The children who will undergo the multidomain treatment will also experience functional improvements in individual areas? * Thy type of treatment will improve motivation, active participation and satisfaction in children? Researcher will compare the multidomain treatment to standard care proposed by the included clinical centers: single domain rehabilitation with one innovative device. Both groups will undergo also conventional multidomain therapy. This will be done to see if using a holistic approach, and including every need of the child in the rehabilitation plan, can lead to greater improvements in quality of life compared to the control group. Participant will: * Be evaluated 3 times with clinical outcome measures * Take part in a rehabilitation program, at least 20 x 2hours sessions treatment, organized in: * 4 weeks, 5 times per week * 7 weeks, 3 times per week