Treatment Trials

12 Clinical Trials for Various Conditions

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RECRUITING
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
Description

The purpose of this study is to characterize the cortical connectivity changes in the brain of spastic diplegic children after Selective Dorsal Rhizotomy.

COMPLETED
Eye-Hand Coordination in Children With Spastic Diplegia
Description

This study will examine how the brain controls eye-hand coordination (visuomotor skills) in children with spastic diplegia and will determine whether impairment of this skill is related to the learning difficulties in school that some of these children experience. Spastic diplegia is a form of cerebral palsy that affects the legs more than the hands. The brain injury causing the leg problem in this disease may also cause difficulty with eye-hand coordination. Healthy normal volunteers and children with spastic diplegia between 6 and 12 years of age may be eligible for this study. Candidates will be screened with a review of medical and school records, psychological testing, neurological and physical examinations, and assessment of muscle function in the arms and legs. Participants may undergo one or more of the following procedures: Neuropsychological testing (1 to 2 hours) - involves sitting at a computer and answering questions, such as whether the letters on the screen make up a real word. Magnetic resonance imaging (MRI) (45 minutes) - uses a strong magnetic field and radio waves to provide images of the brain. The child lies on a table in a narrow cylindrical machine while the scans are obtained. Both the child and parent wear earplugs to muffle the loud noise the radio waves make while the images are formed. Electroencephalography (EEG) and electromyography (EMG) (1 to 2 hours) - EEG uses electrodes to record the electrical activity of the brain. The electrodes are in a special cap that is worn on the head during the procedure. EMG records electrical activity from muscles. Electrodes are placed on the skin over certain muscles. During the test, the child makes simple repetitive movements, such as finger tapping. The cap and the electrodes on the skin are removed at the end of the test.

COMPLETED
FES Assisted Cycling in Children With CP
Description

This project proposes to assess if Functional Electrical Stimulation (FES) assisted cycling can improve the cycling ability, muscle strength, cardiovascular health, quality of life, self perception and functional mobility of adolescents with CP better than a volitional cycling program or a non-intervention control group.

COMPLETED
Cerebral Palsy: Short-burst Interval Training
Description

This study examines the effect of short burst interval treadmill training in ambulatory children with cerebral palsy. Half the sample will receive 20 sessions of training over 4 weeks, while half will receive the training over 10 weeks.

TERMINATED
FES to Improve Gait in CP
Description

The goal of this proposal is to mitigate the typical decline in walking function experienced by children with cerebral palsy (CP) via a Functional Electrical Stimulation (FES)-assisted treadmill training intervention. In this study, the investigators intend to use thier CP FES Gait Training System to assess the neurotherapeutic effects of an FES-assisted treadmill training intervention on walking performance in children with CP. The research design consists of a randomized, controlled, two-treatment study in which the control subjects will cross-over into one of the two treatment groups. An FES-assisted training group will undergo twelve weeks of FES-assisted treadmill training using a distributive practice protocol consisting of alternating bouts of walking with and without FES assistance, followed by over ground walking reinforcement. A treadmill-only training group will undergo the same training regimen without FES-assistance. Finally, a non-intervention group will serve as a control. The investigators will analyze treatment efficacy via functional and biomechanical and measures collected pre-training, post-training and after a twelve-week follow-up period.

ACTIVE_NOT_RECRUITING
ADX-629 Therapy for Sjogren-Larsson Syndrome
Description

This research study will determine whether orally administered ADX-629 is safe and has biochemical efficacy in participants with Sjögren-Larsson syndrome (SLS), a rare inherited disorder of fatty aldehyde metabolism The disease is caused by bi-allelic mutations in ALDH3A2, which results in deficient activity of fatty aldehyde dehydrogenase (FALDH) and leads to the build-up of harmful long-chain (C16-C20) aldehydes and alcohols. Accumulation of these lipids and their metabolic products in skin, brain and eyes is responsible for the symptoms, which persist lifelong. ADX-629 is an aldehyde trapping agent that is expected to eliminate fatty aldehydes and negate aldehyde toxicity, improve the biochemical abnormalities and have clinical efficacy for SLS. The primary objective of this clinical protocol is to determine whether ADX-629 is safe and tolerable for use in SLS subjects. The secondary objective is to determine the efficacy of ADX-629 in reversing the biochemical abnormalities in SLS. Exploratory objectives are to evaluate the short-term clinical effects of ADX-629 on neurologic, cutaneous and ophthalmologic disease in SLS. Participants will be treated with ADX-629 for 12 weeks and monitored for safety and biochemical efficacy.

COMPLETED
Sjogren-Larsson Syndrome: Natural History, Clinical Variation and Evaluation of Biochemical Markers
Description

Sjogren-Larsson syndrome (SLS) is a rare genetic disease in which patients typically exhibit ichthyosis (dry, scaly skin), intellectual disability, spasticity, seizures and a distinctive maculopathy. The purpose of this study is to define the clinical spectrum and natural history of Sjogren-Larsson syndrome, and identify biomarkers that correlate with disease phenotype while establishing a registry for future investigations of biochemical pathogenesis and therapy.

COMPLETED
Study of a Stationary Cycling Intervention for Children With Spastic Diplegic Cerebral Palsy
Description

The study is about the effect of an exercise program using stationary bicycling for children with the spastic diplegic form of cerebral palsy. Spastic diplegia is a type of cerebral palsy that involves spasticity or "tightness" of the leg muscles. We hope to learn whether this type of exercise will allow the children to develop improved strength in the muscles that bend and straighten their knees, enhance their level of physical fitness, improve their ability to walk and improve their ability to perform other activities that are important to them. We hypothesize that children who participate in the stationary cycling intervention will gain strength in the muscles that bend and straighten their knees, will be able to complete a 600 yard walk run test (a test of endurance) more rapidly, and will improve their score on a test of function called the Gross Motor Function Measure (a test designed specifically for children with cerebral palsy).

UNKNOWN
Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy
Description

The purpose of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy.

COMPLETED
Brain Control of Movements in Cerebral Palsy
Description

This study will examine how the brain controls movements in patients with certain types of cerebral palsy. In healthy people, one side of the body usually controls movements on the other side of the body. In patients with cerebral palsy, this pattern may be altered, and one side of the brain may control movements on the same side of the body. Information obtained from this study may lead to improved rehabilitation therapy strategies for patients with cerebral palsy. Healthy volunteers and patients with cerebral palsy between 6 and 18 years of age may be eligible for this study. All candidates will be screened with a medical history, physical examination, and psychological testing. In addition, patients with cerebral palsy will have hearing and vision tests, a review of their medical records, and a magnetic resonance imaging (MRI) scan if one has not been done within the past year. For this test, the patient lies on a table that slides into a narrow metal cylinder with a strong magnetic field (the scanner). The scanning time usually lasts between 45 and 90 minutes. Patients enrolled in the study also will be evaluated by a physiatrist and physical and occupational therapists. They will be examined for muscle stiffness and reflexes. Their gait and movements (e.g., how they pick up a glass of water) will be evaluated. They will be asked about their ability to perform activities around the house and at school and whether a wheelchair or walker is needed to get around. Patients may also be asked about how they are dealing with their movement problems and how it affects their caregivers. All participants will undergo three tests, described below, to evaluate movement control. The first two tests use electrodes (small metal discs) taped to the skin over the muscles in both hands to measure muscle activity. A small disc placed on the fingers detects and measures the hand movements. The third test uses magnetic pulses that stimulate the brain to study how the brain controls movements. 1. Quantitative test of fine motor function: For this test, the subject taps buttons at different speeds on a box attached to a computer. The test is similar to playing simple computer games. 2. Long latency reflexes: For this test, the subject's hand is lightly strapped into a holder that holds the hand still while a motor moves the index finger with sudden small movements. These reflexes may also be tested using a gentle shock to the finger delivered through a ring electrode. 3. Transcranial magnetic stimulation: For this test, the subject sits in a comfortable chair. An insulated coil is held on the scalp. A magnetic pulse from the coil stimulates the brain. The subject may hear a click and feel a snap or pulling sensation on the scalp under the coil. The stimulation may also cause twitching in the muscles of the arm or leg. During the stimulation, the subject may be asked to move certain muscles or perform other simple actions.

Conditions
COMPLETED
Precision Gait Retraining for Children With Cerebral Palsy
Description

This project will develop the first sensor-based mobile Pelvic Assist Device (mPAD) that can deliver precise, adaptable, pelvic control to restore natural coordination of upper- and lower-limb movements during gait in children with Cerebral Palsy

COMPLETED
Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy
Description

The investigators hypothesize that children with spastic cerebral palsy will show greater improvements in gross motor function, associated developmental skills and growth after the 3 months of myofascial structural integration treatment, a form of deep massage, than they showed after a 3- or 6-month pre-treatment waiting period. The investigators further hypothesize that children with spastic CP will maintain their gains in gross motor function for ≥ 3 months after completion of MSI treatment.